The scope of the issue is deliberately broad, spanning six thematic areas that together map the full journey of a drug product from early-stage design to commercial manufacture. These include particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies for oral, injectable, inhalable, transdermal, and other dosage forms; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies in dosage form design and commercial production; and the application of Quality by Design and Process Analytical Technology frameworks to formulation and manufacturing. Together, the topics describe a discipline that sits at the hinge between synthetic chemistry and clinical medicine, where the physical form of a compound can determine whether an innovative drug ever helps a patient.

The emphasis on particle engineering reflects a well-known bottleneck in modern drug development. A large fraction of newly discovered drug candidates are poorly soluble in water, which limits their absorption in the gastrointestinal tract and forces formulators to find creative ways to deliver an effective dose. Particle engineering tackles this problem at its root by manipulating crystal form, particle size, shape, and surface properties. Techniques such as micronization, nanosizing, spray drying, hot-melt extrusion, and controlled crystallization can dramatically increase the effective surface area of a drug or convert it into a more soluble amorphous state, thereby boosting bioavailability without altering the molecule itself.

Solid-state science is the quiet foundation beneath these efforts. The same drug molecule can crystallize into multiple distinct forms, known as polymorphs, each with its own solubility, stability, and mechanical behavior. A change in crystal form during manufacturing or storage can cause a formulation to fail regulatory specifications or lose potency, a risk that has derailed commercial products in the past. The special issue’s focus on solid-state characterization and control underscores how much attention is now devoted to selecting, monitoring, and locking in the right physical form early in development, using tools such as X-ray powder diffraction, differential scanning calorimetry, Raman spectroscopy, and dynamic vapor sorption to fingerprint every batch.

The translational dimension of the issue is equally significant. In pharmaceutical parlance, translation means the movement of a formulation concept out of the research laboratory and into robust, reproducible, large-scale production. A tablet or suspension that works beautifully on a small benchtop mixer can behave entirely differently in a two-thousand-liter industrial vessel, where mixing efficiency, drying rates, and heat transfer change dramatically. Formulation scientists increasingly design experiments to anticipate these scale effects from the outset, selecting excipients and unit operations that can be transferred to the plant without compromising product quality. Papers addressing scale-up of drug products will speak directly to one of the most persistent pain points in the industry.

Emerging manufacturing technologies represent another pillar of the call for papers. Continuous manufacturing, in which raw materials flow through an integrated production line rather than moving in discrete batches, has gained regulatory acceptance in recent years and promises tighter process control, smaller facility footprints, and faster response to demand. Additive manufacturing, including 3D printing of dosage forms, allows drug products with complex release profiles or personalized doses to be fabricated layer by layer. These technologies dovetail with the special issue’s interest in quality frameworks, because continuous and digital manufacturing depend on real-time data streams to keep every unit of product within specification.

That dependence explains the prominence of Quality by Design and Process Analytical Technology, two paradigms that have reshaped how regulators and manufacturers think about pharmaceutical quality. Quality by Design asks developers to build scientific understanding of how formulation and process variables affect the final product, so that quality is designed into the medicine rather than tested in afterward. Process Analytical Technology supplies the instrumentation for that approach, embedding sensors such as near-infrared and Raman probes directly into mixers, dryers, and tablet presses so that critical quality attributes can be measured during production. The special issue’s inclusion of these frameworks signals an interest in submissions that demonstrate not just novel formulations but principled, data-driven development strategies that regulators can evaluate with confidence.

The range of dosage routes covered in the call reflects the diversity of modern drug delivery. Oral solid dosage forms remain the dominant commercial product class, but injectable biologics, inhalable powders for respiratory disease, and transdermal patches each impose their own particle and formulation requirements. Inhaled medicines, for example, depend on exquisitely controlled particle sizes, typically in the range of one to five micrometers, to deposit drug in the deep lung rather than the throat. Injectable suspensions must balance particle size against needle clogging and long-term physical stability. Transdermal systems require drug molecules to permeate the skin at therapeutic rates, often aided by penetration enhancers or engineered adhesive matrices. A journal issue that spans all of these routes implicitly argues that the underlying science of particles and formulations is a common language across delivery platforms.

Underlying all of these themes is a candid acknowledgment that drug delivery has become one of the decisive factors in whether new therapies succeed. Many biologics require sophisticated formulations to survive manufacturing, storage, and administration; small molecules increasingly need enabling technologies to achieve adequate oral exposure; and combination products must integrate devices with drug formulations in seamless designs. By soliciting work that moves from molecular-level particle design to commercial production, the guest editors are positioning the special issue as a venue for research with direct industrial relevance, not merely laboratory novelty. The January 2027 publication date gives prospective authors roughly a year and a half from the announcement window to prepare manuscripts, a timeline consistent with the journal’s aim of assembling a coherent snapshot of the field rather than a loose collection of incremental studies.

For researchers working at the intersection of materials science, chemical engineering, and pharmaceutics, the call for papers arrives at a moment when the boundaries between those disciplines are dissolving. Machine learning is being used to predict polymorph stability and optimize formulation compositions, process models built from first principles are replacing purely empirical scale-up rules, and real-time analytics are turning manufacturing lines into data-generating laboratories. The special issue’s six topics read, in that light, as an invitation to demonstrate that particle engineering and formulation science are no longer supporting disciplines but central engines of pharmaceutical innovation, capable of rescuing otherwise unpromising molecules and delivering them to patients in forms that are stable, manufacturable, and clinically effective.

Subject of Research: Pharmaceutical formulation science and particle engineering for drug dosage form development

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, dosage forms, pharmaceutics, translational research

The announcement arrives at a moment when the pharmaceutical industry is confronting a persistent and expensive problem: a large proportion of drug candidates emerging from discovery pipelines are poorly soluble in water, which severely limits how much of an administered dose actually reaches the bloodstream. Particle engineering offers a family of physical and chemical strategies for overcoming this barrier. By controlling the size, shape, crystal form, and surface properties of drug particles, formulators can dramatically alter dissolution rate, solubility, and ultimately bioavailability. Reducing particle size into the micrometer or nanometer range increases the surface area available for dissolution, while converting a crystalline drug into an amorphous solid dispersion can produce an apparent solubility advantage that enables oral absorption of otherwise unusable molecules. These are precisely the kinds of approaches the special issue seeks to showcase.

The scope of the call for papers is deliberately broad, spanning six thematic areas that together map the modern landscape of dosage form development. The first covers particle engineering approaches for solubility, stability, and bioavailability enhancement, the core discipline that underpins much of contemporary formulation work. The second addresses advanced formulation strategies for pharmaceutical dosage forms, explicitly including oral, injectable, inhalable, and transdermal routes as well as advanced drug delivery systems. The third focuses on solid-state characterization and control, the analytical backbone that determines whether a carefully engineered drug form survives manufacturing, storage, and the acidic environment of the stomach. The remaining themes address translational formulation science and scale-up, emerging manufacturing technologies, and the application of Quality by Design and Process Analytical Technology frameworks to formulation and production.

Solid-state science deserves particular attention because it sits at the intersection of chemistry, engineering, and regulatory science. A single active pharmaceutical ingredient can exist in multiple crystalline polymorphs, each with a different arrangement of molecules in the solid lattice and therefore different physical properties such as melting point, dissolution behavior, and mechanical stability. The most stable polymorph at a given temperature and pressure dissolves most slowly, while metastable forms that dissolve faster may spontaneously convert to the stable form during processing or storage, erasing the intended performance benefit overnight. Amorphous materials sidestep the lattice entirely but carry their own risk of recrystallization, often requiring polymeric stabilizers and careful control of moisture and temperature. Characterization techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to fingerprint these forms and monitor them throughout a product’s life cycle, which is why the special issue lists solid-state control as a standalone topic.

The emphasis on translation and scale-up reflects a hard truth in pharmaceutical development: a formulation that performs beautifully on a laboratory bench may fail when produced at commercial scale. Processes such as hot-melt extrusion, spray drying, and high-shear wet granulation behave differently when the batch size grows by orders of magnitude, because heat transfer, drying kinetics, and mixing efficiency do not scale linearly. A nanosuspension prepared by wet milling in a small vessel may show a different particle size distribution when the same milling media and residence times are applied in industrial equipment. Translational formulation science seeks to anticipate these changes, designing processes and formulations that remain robust from the first gram to the final tonne. Contributions that document this journey, including the failures and fixes along the way, are exactly the kind of practical knowledge that the guest editors appear to want gathered in one place.

Emerging manufacturing technologies form another pillar of the issue. Continuous manufacturing has been gaining ground in the pharmaceutical industry as an alternative to traditional batch processing, offering tighter control, smaller footprints, and the ability to move material directly from powder feed to finished tablet without intermediate storage. Additive manufacturing, most visibly three-dimensional printing, has demonstrated the ability to produce dosage forms with complex internal geometries and personalized doses that conventional tableting cannot achieve. Other technologies, including electrospinning for nanofibrous drug carriers, supercritical fluid processing for solvent-free particle formation, and microfluidic platforms for the reproducible production of lipid nanoparticles, are expanding the toolbox available to formulators. The special issue’s inclusion of commercial production among its emerging technologies signals an interest not only in laboratory novelties but in processes that can realistically be validated, licensed, and run at industrial scale.

The sixth thematic area, Quality by Design and Process Analytical Technology, represents a regulatory philosophy that has reshaped how drug products are developed and approved. Quality by Design asks developers to begin with predefined objectives, identify the critical material attributes of both drug substance and excipients, and understand how process parameters affect the quality attributes of the final product. Rather than testing quality into a finished batch, the goal is to build it in through design space definition and risk management. Process Analytical Technology supplies the real-time measurement tools that make this possible: near-infrared spectroscopy can monitor blend uniformity inside a granulator, Raman spectroscopy can track polymorphic conversion during crystallization, and laser diffraction can verify particle size in a spray-drying stream without stopping the process. Together these frameworks allow continuous verification of product quality and support the regulatory flexibility that modern agencies increasingly expect.

The breadth of dosage routes named in the call, from oral tablets to injectables, inhalables, and transdermal systems, underscores how particle engineering principles cut across delivery technologies. Inhaled medicines depend on aerodynamic particle size in a narrow range, typically a few micrometers, to deposit in the deep lung rather than the throat, making particle size control a direct determinant of therapeutic performance. Transdermal patches rely on drug properties and formulation design to drive molecules through the skin barrier at controlled rates. Injectable formulations, including long-acting suspensions and emerging nanocarriers, depend on particle characteristics for both syringeability and the duration of drug release after administration. By inviting contributions across all of these routes, the editors are framing particle engineering not as a niche specialty but as a unifying discipline of pharmaceutics.

The guest editorial team brings a combination of academic and translational experience to the project. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research, Min-Soo Kim of Pusan National University works extensively on particle engineering and solubility enhancement technologies, and Heejun Park of Duksung Women’s University contributes expertise in pharmaceutics and formulation development. Their decision to devote a full special issue to translational aspects, rather than to a single technology, suggests an intent to capture a snapshot of the field as it stands in the middle of the decade, with an eye toward what actually reaches patients. For the Journal of Pharmaceutical Investigation, which serves an international readership of pharmaceutical scientists, the January 2027 issue could function as a reference collection for both academic researchers and industry formulators.

For researchers in pharmaceutics, the announcement is effectively an open invitation to publish work where it will be read by the community that matters most to this discipline. The June 30, 2026 deadline provides a concrete target for groups with mature datasets on nanocrystal stabilization, amorphous solid dispersion manufacturability, continuous processing case studies, or analytical method development for solid-state control. As drug molecules continue to grow larger, less soluble, and more demanding in their delivery requirements, the value of disciplined particle engineering and formulation science only increases. Whether the next generation of medicines arrives as printed personalized tablets, continuously manufactured amorphous dispersions, or inhalable nanocarriers, the path from molecule to medicine will run through the same territory this special issue is designed to map: the controlled manipulation of particles and formulations, translated reliably from laboratory insight to industrial product.

Subject of Research: A special issue of the Journal of Pharmaceutical Investigation on translational pharmaceutical dosage form development through particle engineering and formulation science

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solid dispersions, pharmaceutical scale-up, dosage forms, Journal of Pharmaceutical Investigation

The timing of the call reflects a growing crisis in drug development that has little to do with discovering new molecules and everything to do with delivering them. An estimated large fraction of newly discovered drug candidates, particularly those emerging from high-throughput screening campaigns, are classified as poorly water-soluble. These compounds may bind their biological targets beautifully in vitro yet fail to reach therapeutic concentrations in the bloodstream because they simply cannot dissolve in gastrointestinal fluids. Particle engineering has emerged as the discipline that confronts this problem head-on, manipulating the size, shape, morphology, and solid-state form of drug particles to maximize the surface area available for dissolution and to stabilize thermodynamically unfavorable but therapeutically useful states.

Among the most influential techniques in this field is micronization, which reduces particle size into the low-micrometer range, and its more extreme descendant, nanonization, which pushes particles below one micrometer and often below 100 nanometers. At these scales, according to the Noyes-Whitney equation that governs dissolution kinetics, the rate at which a particle dissolves is directly proportional to its surface area, so shrinking particles dramatically accelerates the release of drug into solution. Nanocrystal suspensions stabilized by surfactants or polymeric stabilizers have already reached the market in several oral and injectable products, demonstrating that particle-scale manipulation can translate into clinically meaningful improvements in bioavailability. The special issue explicitly invites contributions on such particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that the editors want the full breadth of current methodology represented.

Equally central to the call is solid-state science, the study of how drug molecules arrange themselves in the solid phase. A single active pharmaceutical ingredient can exist in multiple crystalline polymorphs, each with a distinct lattice energy and therefore a distinct solubility, melting point, and physical stability profile. It can also be rendered amorphous, lacking any long-range crystalline order, which confers a substantial solubility advantage but introduces the persistent risk of recrystallization during storage. The infamous case of ritonavir, an HIV protease inhibitor whose market launch was derailed in the late 1990s when a previously unknown, more stable and far less soluble polymorph spontaneously appeared in production, remains the canonical warning of what happens when solid-state behavior is incompletely mapped. Modern developers now deploy a battery of characterization tools, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance, to detect and control these forms, and the special issue places solid-state characterization and control squarely among its priority topics.

Beyond solubility, the call for papers reaches across the entire landscape of dosage forms and delivery routes. The editors list advanced formulation strategies for oral, injectable, inhalable, and transdermal products, alongside broader advanced drug delivery systems. Each route imposes its own demanding constraints. Oral formulations must survive gastric acid, digestive enzymes, and the variable pH of the intestinal tract before releasing their payload at the right site and rate. Inhaled products must generate aerosol droplets or dry powder particles in a narrow aerodynamic size band, typically one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must drive molecules across the skin’s stratum corneum, a barrier that admits very few drugs, often requiring chemical permeation enhancers, microneedle arrays, or engineered vesicles. Injectable formulations face the strictest requirements of all, demanding sterility, isotonicity, appropriate viscosity, and freedom from particulate contamination. Formulation science is the discipline that reconciles a molecule’s intrinsic chemistry with these route-specific physiological realities.

A distinctive emphasis of this special issue is translational formulation science and the scale-up of drug products, the often underappreciated passage from a well-behaved bench process to a robust manufacturing operation producing hundreds of thousands of units. Processes that work flawlessly in a one-kilogram laboratory batch can behave entirely differently at industrial scale. Spray drying, hot-melt extrusion, high-shear wet granulation, and fluid-bed coating all involve heat and mass transfer phenomena whose balance shifts with equipment geometry, batch size, and processing time. A spray-dried amorphous dispersion, for example, depends on rapid solvent evaporation to lock the drug in its amorphous state; slower drying at scale can allow phase separation or crystallization that destroys the solubility advantage the technology was chosen to deliver. Translational research that documents how formulation critical quality attributes survive, or fail to survive, the journey to commercial scale is precisely what the editors hope to attract.

Running through the topic list is a pair of acronyms that have reshaped pharmaceutical manufacturing culture over the past two decades: QbD and PAT. Quality by Design is a regulatory philosophy, championed by agencies including the US Food and Drug Administration, that holds that quality should be built into a product by design rather than tested in at the end of the line. In practice, developers identify critical quality attributes of the drug product, determine which raw material properties and process parameters influence them, and establish a design space within which the process can operate while consistently delivering acceptable quality. Process Analytical Technology supplies the real-time sensory apparatus for this vision, using tools such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement to monitor blend uniformity, granule moisture, particle size distribution, and polymorphic form during production rather than after it. Contributions applying QbD and PAT to formulation and manufacturing are explicitly solicited, reflecting how thoroughly these frameworks now permeate both industrial practice and regulatory expectation.

The special issue also embraces emerging manufacturing technologies in dosage form design and commercial production, a category that encompasses some of the most dynamic developments in the field. Additive manufacturing, best known in the form of three-dimensional printing, has already produced the first FDA-approved printed drug product, an orally disintegrating levetiracetam tablet whose highly porous internal architecture enables rapid disintegration. Continuous manufacturing, which replaces the traditional batch-and-warehouse model with a steady flow of material through integrated unit operations, promises shorter production times, smaller footprints, and tighter process control, and has gained regulatory acceptance in several recent drug product approvals. Other frontiers include microfluidic production of lipid nanoparticles, the delivery platform underpinning mRNA vaccines, and precision coating technologies that enable functional film layers measured in micrometers. Researchers working on such technologies will find their subject matter directly addressed in the call for papers.

For the pharmaceutical research community, the significance of the issue lies in its insistence on the word translational. The history of drug delivery is littered with elegant laboratory concepts, from targeted nanoparticles to stimuli-responsive polymers, that never survived contact with manufacturing economics, regulatory scrutiny, or patient practicality. By framing the issue around particle engineering and formulation science as the engines of dosage form development, the guest editors are drawing attention to the disciplines that decide whether a molecule becomes a medicine. The Journal of Pharmaceutical Investigation, published by Springer, has long served as a venue for research spanning pharmaceutics, drug delivery, and pharmaceutical technology, particularly with strong participation from Asian research groups and industry laboratories, and the January 2027 issue is positioned to consolidate that role.

Researchers wishing to contribute have until June 30, 2026, to submit their manuscripts, with the completed issue slated for January 2027. Correspondence regarding the issue is directed to the three guest editors at their respective institutions. For scientists working at the intersection of particle engineering, solid-state chemistry, formulation design, and manufacturing technology, the call represents a focused opportunity to place their work within a collection explicitly dedicated to the path from molecular promise to manufactured product. In an era when biological targets are discovered faster than they can be drugged, and when a growing share of the pharmacopoeia consists of molecules that resist dissolution, the sciences gathered under this special issue’s banner may well determine how much of modern drug discovery ever reaches a patient.

Subject of Research: Translational pharmaceutical dosage form development based on particle engineering and formulation science

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, solid-state characterization, polymorphism, amorphous dispersions, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, bioavailability

The central premise of the special issue is that the physical form of a drug substance is not a fixed property but a design variable. Many of the most promising molecules emerging from modern drug discovery pipelines suffer from poor aqueous solubility, which limits how much of the compound can be absorbed into the bloodstream after oral administration. Particle engineering addresses this problem by manipulating characteristics such as crystal form, particle size, shape, and surface properties to improve dissolution behavior. Techniques in this space include micronization, nanosizing, the creation of amorphous solid dispersions, cocrystal formation, and the design of engineered crystals with tailored habit and surface energy. Each approach alters the thermodynamics and kinetics of dissolution, and each carries trade-offs in stability, manufacturability, and intellectual property positioning.

Solubility enhancement is only one pillar of the call for papers. The guest editors have outlined a scope that also covers advanced formulation strategies across virtually every route of administration, including oral, injectable, inhalable, and transdermal dosage forms, as well as broader advanced drug delivery systems. This breadth reflects a reality of modern pharmaceutics: a molecule’s therapeutic success often depends less on its intrinsic potency than on the delivery system built around it. An inhaled corticosteroid must deposit in the deep lung, which demands tight control of aerodynamic particle diameter, typically in the range of one to five micrometers. A subcutaneous biologic must remain stable in solution at high concentration without aggregating into immunogenic species. A transdermal patch must balance drug flux through the stratum corneum against skin tolerability. Each of these challenges is, at its core, a formulation science problem.

Solid-state characterization and control form a third major theme of the issue. The solid state of a pharmaceutical compound, whether crystalline, amorphous, or somewhere in between, governs properties ranging from dissolution rate and tableting behavior to chemical stability and hygroscopicity. Polymorphism, the ability of a molecule to pack into multiple crystal structures, can produce forms that differ dramatically in solubility and stability, as the industry learned in well-documented cases where a late-appearing polymorph disrupted manufacturing. Modern analytical tools, including powder X-ray diffraction, differential scanning calorimetry, solid-state nuclear magnetic resonance spectroscopy, and dynamic vapor sorption analysis, allow scientists to detect and quantify these subtle structural differences. The special issue is expected to highlight work that moves such characterization from a retrospective quality check to a proactive design tool embedded throughout development.

Perhaps the most consequential theme is translational formulation science and scale-up. The pharmaceutical industry has long struggled with what researchers informally call the valley of death: formulations that perform beautifully in a university laboratory but fail when transferred to pilot plants and commercial production lines. Scale-up introduces stresses that bench-top experiments rarely capture, including prolonged high-shear mixing, spray-drying at industrial throughputs, hot-melt extrusion over extended runs, and the fluid dynamics of large-scale granulators and dryers. A nanosuspension prepared in a small beaker may aggregate within hours when produced continuously at kilogram scale. An amorphous dispersion that remained stable for two years in a stability chamber may crystallize prematurely if the commercial process leaves residual solvent or moisture in the product. Translational science in this context means designing formulations with manufacturability in mind from the first experiment, and the guest editors are explicitly seeking contributions that document this journey from concept to clinic.

Emerging manufacturing technologies constitute another pillar of the announced scope. Continuous manufacturing, in which drug substance and excipients flow through an integrated production line rather than moving batch by batch between discrete unit operations, has gained regulatory acceptance and industrial momentum because it offers tighter process control, smaller footprints, and faster response to demand changes. Additive manufacturing, commonly known as three-dimensional printing, enables dosage forms with complex internal geometries and personalized doses that conventional compression or encapsulation cannot achieve. Other technologies in active development include electrospinning for nanofibrous drug carriers, supercritical fluid processing for solvent-free particle production, and hot-melt extrusion for continuous amorphous dispersion manufacturing. Each of these platforms depends on precise particle and formulation science, since the final product’s performance is determined at the level of molecular arrangement and microstructure.

The special issue also places Quality by Design and Process Analytical Technology at the center of its scope. Quality by Design, often abbreviated as QbD, is a regulatory philosophy that asks manufacturers to build quality into a product through systematic understanding rather than testing it in afterward. Under this framework, developers identify critical quality attributes, such as dissolution rate or particle size distribution, and map them against critical process parameters, such as milling speed, spray-drying inlet temperature, or granulation liquid addition rate. Design of experiments and mechanistic modeling then establish a design space within which the product reliably meets specifications. Process Analytical Technology, or PAT, supplies the real-time sensing that makes such control practical: near-infrared spectroscopy can monitor blend uniformity inside a running blender, Raman spectroscopy can track polymorphic transformation during crystallization, and focused beam reflectance measurement can follow particle growth in suspension. Together, QbD and PAT shift pharmaceutical manufacturing closer to the feedback-controlled paradigms familiar in other high-technology industries.

The timing of the call reflects broader pressures on the pharmaceutical sector. A large fraction of new chemical entities in development pipelines are classified as poorly soluble, and the proportion has been rising for decades as combinatorial chemistry and high-throughput screening favor lipophilic, high-molecular-weight compounds. At the same time, biologics, antibody-drug conjugates, RNA therapeutics, and other modalities demand delivery systems that protect fragile molecules from degradation and release them at the right site and rate. Regulatory agencies worldwide are encouraging continuous manufacturing and advanced analytics to improve supply chain resilience and reduce drug shortages. In this environment, the disciplines represented in the special issue, particle engineering, formulation design, solid-state science, and process technology, are no longer back-office support functions but strategic capabilities that determine whether a drug candidate reaches patients at all.

For researchers considering submission, the June 30, 2026 deadline leaves roughly a year and a half of preparation time, and the January 2027 issue date positions the collection to capture the current state of a fast-moving field. The guest editors’ combined affiliations, spanning Yonsei University, Pusan National University, and Duksung Women’s University, reflect South Korea’s substantial investment in pharmaceutical manufacturing science, a sector in which the country has built internationally recognized expertise in generics, biosimilars, and increasingly in original formulation technologies. By soliciting work that explicitly emphasizes translational advances, the editors are signaling that incremental characterization studies alone will not suffice; the issue aims to showcase science that demonstrably moves dosage forms closer to the market and to the patient.

What makes this collection potentially significant beyond the pharmaceutical community is the way it illustrates a general principle of modern medicine: the therapeutic value of a molecule is inseparable from the engineering of its physical presentation. A breakthrough compound that dissolves too slowly, aggregates in storage, or cannot be manufactured reproducibly is, in practical terms, not a medicine. The work invited for this special issue, spanning solubility enhancement, multi-route delivery systems, solid-state control, scale-up science, emerging manufacturing platforms, and quality-by-design frameworks, addresses precisely the points where molecular promise most often stalls. Readers following the intersection of chemistry, engineering, and medicine can expect the January 2027 issue to offer a detailed snapshot of how the industry converts laboratory molecules into reliable, manufacturable, patient-ready dosage forms, and of the particle-level decisions on which that conversion ultimately depends.

Subject of Research: Translational pharmaceutical dosage form development using particle engineering and formulation science

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, pharmaceutical dosage forms, bioavailability, Journal of Pharmaceutical Investigation

Three guest editors based in South Korea will steer the issue: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. All three are active researchers in pharmaceutics and drug delivery, and their combined expertise spans the design of dosage forms, the engineering of drug particles, and the translation of laboratory formulations into manufacturable drug products. Their editorial leadership reflects the journal’s positioning at the intersection of academic formulation science and industrial pharmaceutical development, a space where ideas must survive not only biological testing but also the realities of scale-up, regulatory scrutiny, and commercial production.

The scope of the call is deliberately broad, covering particle engineering approaches for enhancing solubility, stability, and bioavailability. This trio of properties sits at the heart of a persistent problem in drug development: a large proportion of newly discovered active pharmaceutical ingredients are poorly soluble in water, which limits how much of the drug can be absorbed into the bloodstream after oral administration. Particle engineering attacks the problem at its physical root. By reducing particle size to the micrometer or even nanometer scale, formulators dramatically increase the surface area available for dissolution, allowing poorly soluble drugs to dissolve faster and more completely in the gastrointestinal tract. Techniques such as wet milling, high-pressure homogenization, spray drying, and supercritical fluid processing are among the industrial workhorses used to achieve these size reductions in a controlled and reproducible way.

But particle engineering is not only about making particles smaller. It is equally about controlling the solid state of the drug itself. Many pharmaceutical compounds can exist in multiple crystalline forms, known as polymorphs, as well as in amorphous, non-crystalline states. Each form carries a distinct free energy, and that energy difference translates directly into different dissolution rates, different physical stabilities, and different tendencies to convert from one form to another over a product’s shelf life. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer matrix, can generate dramatic solubility improvements, yet they carry the risk of recrystallization during storage. The special issue’s explicit attention to solid-state characterization and control acknowledges that understanding and managing these transformations, using tools such as X-ray powder diffraction, differential scanning calorimetry, and spectroscopic methods, is essential to delivering formulations that remain stable from factory to pharmacy.

A second major theme of the call is advanced formulation strategies across the full spectrum of dosage routes: oral, injectable, inhalable, transdermal, and beyond, together with advanced drug delivery systems. Each route imposes its own demanding constraints. Oral solid dosage forms must survive manufacturing stresses such as compression and coating while releasing the drug at the right site and rate in the body. Injectable formulations must be sterile, isotonic, and free of particles that could trigger adverse reactions, and increasingly they must stabilize delicate biologics such as proteins and peptides that denature under thermal or interfacial stress. Inhalable products require particles engineered to an aerodynamic diameter typically between one and five micrometers so they can deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push drugs across the skin’s formidable barrier layer at therapeutic rates. The breadth of this topic area invites contributions that show how particle and formulation design principles adapt to these very different delivery challenges.

Perhaps the most distinctive emphasis of the special issue, and the one captured in its title, is translation. The editors are calling for work on translational formulation science and the scale-up of drug products, a stage of development where many promising laboratory formulations falter. A process that works beautifully at the gram scale in a research lab may behave very differently in a kilogram-scale manufacturing run, where mixing efficiency, heat transfer, drying kinetics, and equipment geometry all change. Spray drying a nanosuspension on a laboratory benchtop is a fundamentally different operation from running a commercial-scale dryer for hours at a time. Translational formulation science seeks to understand these shifts in advance, building formulations and processes that are robust by design rather than rescued through trial and error after scale-up failures occur.

Closely tied to this translational theme is the call’s inclusion of emerging manufacturing technologies in dosage form design and commercial production. Continuous manufacturing, in which drug product is produced in an uninterrupted flow rather than in discrete batches, has gained significant regulatory and industrial momentum because it offers tighter process control, smaller facility footprints, and faster response to demand changes. Additive manufacturing, including various three-dimensional printing approaches, opens the possibility of dosage forms with complex internal geometries and, in principle, personalized doses tailored to individual patients. Hot-melt extrusion, which combines mixing, melting, and shaping in a single continuous operation, has become a standard industrial method for producing amorphous solid dispersions of poorly soluble drugs. Contributions describing how such technologies reshape what is possible in dosage form design are squarely within the issue’s scope.

The final pillar of the call is the application of Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, to pharmaceutical formulation and manufacturing. QbD is a regulatory philosophy, formalized in international guidelines, that asks developers to build quality into a product from the start rather than testing it in at the end. In practice this means systematically identifying the critical material attributes of ingredients and the critical process parameters of manufacturing, then demonstrating how they relate to the quality attributes the patient ultimately experiences. PAT supplies the real-time measurement tools that make this vision workable: near-infrared spectroscopy probes that monitor blend uniformity inside a mixer, Raman sensors that track the solid form of a drug during drying, and feedback control systems that adjust process conditions the moment a deviation appears. Together, QbD and PAT transform formulation development from an empirical craft into a predictive, science-based engineering discipline.

For researchers working in these areas, the timeline offers a clear runway. Manuscripts are due by June 30, 2026, giving teams roughly a year and a half from the announcement to complete studies, and the issue itself is slated for January 2027. The topics list functions as a map of where the field sees its own frontier: solubility and bioavailability enhancement through particle design, advanced delivery systems across every major route, solid-state control, scale-up science, novel manufacturing, and quality-driven process development. Contributions that bridge basic science and commercial reality, showing not just that a formulation works in the laboratory but that it can be made reliably, characterized rigorously, and produced at scale, are likely to define the collection.

The announcement also underscores a broader shift in how the pharmaceutical sciences understand their own role. The era in which a drug molecule alone determined therapeutic success is giving way to one in which the dosage form is recognized as an engineered system in its own right, one whose particle properties, solid-state architecture, and manufacturing history are as consequential as the molecule it carries. By dedicating a full special issue to particle engineering and formulation science, and by framing it explicitly around translation, the Journal of Pharmaceutical Investigation and its guest editors are staking out the position that the path from molecule to medicine runs directly through this discipline, and that the tools now available, from nanoscale particle design to real-time process analytics, are finally mature enough to make that path faster, more predictable, and more scientifically grounded than ever before.

Subject of Research: A special issue call for research on particle engineering and formulation science in pharmaceutical dosage form development

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, process analytical technology, continuous manufacturing, amorphous solid dispersions, scale-up, dosage forms, Journal of Pharmaceutical Investigation

The central premise of the special issue reflects one of the most consequential challenges in modern pharmacology. A striking proportion of newly discovered drug candidates, particularly small molecules emerging from high-throughput screening campaigns, suffer from poor aqueous solubility. A compound may show exquisite activity against its biological target in vitro, yet fail to reach therapeutic concentrations in the bloodstream because it simply cannot dissolve in gastrointestinal fluids or plasma. Particle engineering addresses this problem at its physical root, manipulating the size, shape, morphology, and solid-state form of drug particles to alter how they interact with solvents and biological membranes. Reducing particle dimensions into the micrometer or nanometer range dramatically increases the surface-area-to-volume ratio, accelerating dissolution rates and, in many cases, improving the extent of absorption.

The announced scope of the issue explicitly highlights particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that the editors expect submissions spanning the full toolkit of modern particle science. This includes well-established techniques such as micronization by jet milling and controlled crystallization, alongside newer strategies like nanosizing through wet media milling or high-pressure homogenization, spray-drying to produce amorphous solid dispersions, and supercritical fluid technologies that generate particles with precisely tailored characteristics. Each method carries distinct trade-offs between dissolution advantage and physical stability, since finely divided and amorphous materials often possess thermodynamic drive to revert to more stable, less soluble crystalline forms during storage. Managing that instability, through polymer stabilization, careful selection of solid-state form, and sophisticated packaging, remains a defining concern of the field.

Closely allied to particle engineering is the discipline of solid-state characterization and control, another named topic of the special issue. Pharmaceutical solids can exist in multiple crystalline polymorphs, each with a distinct arrangement of molecules in the crystal lattice and, consequently, distinct solubility, melting point, mechanical behavior, and stability profile. The most infamous cautionary tale is that of ritonavir, an antiretroviral drug whose late-emerging, more stable polymorph precipitated from marketed formulations in the late 1990s, forcing a withdrawal and reformulation that cost the manufacturer hundreds of millions of dollars. Modern development therefore treats polymorph screening, salt and co-crystal selection, and amorphous material characterization as foundational activities. Analytical techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint each solid form and monitor whether it persists unchanged through processing, storage, and administration.

The special issue also casts a deliberately wide net over dosage forms and delivery systems, encompassing oral, injectable, inhalable, and transdermal products, among others, together with advanced drug delivery systems. Each route imposes its own particle and formulation requirements. Oral solid dosage forms, still the dominant category by volume, depend on powder flow, compressibility, and disintegration behavior that are all sensitive to particle attributes. Injectable formulations, including the rapidly growing class of subcutaneous biologics, confront constraints of viscosity, syringeability, and particulate contamination that push formulation scientists toward high-concentration protein solutions and long-acting crystalline suspensions. Inhalable medicines demand particles within a tight aerodynamic diameter window, typically one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must balance drug permeability through the stratum corneum against the adhesive and rheological properties of the matrix. The editors’ inclusive framing suggests they anticipate cross-cutting insights that transfer across these boundaries.

Perhaps the most distinctive emphasis of the announcement is its insistence on translational formulation science and the scale-up of drug products. This theme addresses a well-recognized valley of death in pharmaceutical development: formulations that perform beautifully at the one-gram or one-liter laboratory scale frequently behave differently when produced in hundreds of kilograms. Mixing efficiency, drying kinetics, granulation behavior, and even the solid form itself can shift during scale-up, sometimes with therapeutic consequences. Translational science in this context means designing experiments and models that predict, rather than merely observe, how a formulation will respond to changes in equipment, batch size, and process parameters. Contributions that demonstrate successful technology transfer from research setting to commercial production, or that develop predictive frameworks for such transfers, would sit squarely within the issue’s ambitions.

Emerging manufacturing technologies form another pillar of the announced scope, reflecting an industry in the midst of a production paradigm shift. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations without batch-wise interruption, is steadily displacing traditional batch processing for solid oral doses, offering tighter control, smaller footprints, and faster response to demand. Additive manufacturing, commonly known as three-dimensional printing, has already produced the first approved printed medicine and opens possibilities for personalized dosing and complex release architectures that conventional compression cannot achieve. Hot-melt extrusion, electrospinning, microfluidic nanoparticle production, and advanced coating technologies likewise expand the design space available to formulators. The special issue’s call for work on emerging technologies in dosage form design and commercial production indicates that the editors want not only laboratory proofs of concept but also assessments of how these platforms perform under regulatory and economic scrutiny.

Underpinning all of these themes is the pairing of Quality by Design and Process Analytical Technology, both explicitly named in the issue’s topic list. Quality by Design, a regulatory philosophy codified in international guidance, requires developers to understand and control the relationships between formulation variables, process parameters, and product quality attributes, rather than relying on end-product testing alone. Process Analytical Technology supplies the instrumentation, near-infrared spectroscopy, Raman spectroscopy, laser diffraction, and inline sensors of various kinds, that makes real-time monitoring and control feasible on the factory floor. Together, these frameworks transform formulation development from an empirical craft into a quantitative engineering discipline. Researchers who can demonstrate how PAT tools detect polymorphic transformations during drying, or how design-of-experiments approaches de-risk a scale-up campaign, will be addressing questions that regulators and manufacturers alike regard as essential.

The timing and venue of the special issue carry their own significance. The Journal of Pharmaceutical Investigation, based in South Korea with an increasingly international authorship and readership, has positioned itself as a forum where Asian pharmaceutical science and global industry perspectives converge. South Korea hosts a robust ecosystem of generic and innovative drug manufacturers, contract development organizations, and academic centers, making it a natural vantage point for translational formulation research. A January 2027 publication date places the issue at a moment when the industry is simultaneously absorbing the implications of an expanding pipeline of poorly soluble small molecules, a surging population of biologic drugs requiring novel delivery devices, and mounting pressure to manufacture medicines more flexibly and sustainably. The convergence of these pressures makes particle engineering and formulation science not peripheral technical specialties but central determinants of which drug candidates ultimately reach patients.

For researchers considering submission before the June 30, 2026 deadline, the announcement effectively sketches a map of where the field believes its most valuable contributions lie. Work that connects a particle-level intervention, a new crystallization route, a stabilized nanosuspension, a rationally selected co-crystal, to a demonstrable clinical or commercial outcome will define the translational spirit the guest editors have invoked. Equally, studies that quantify how advanced analytics and design principles reduce development timelines or improve product robustness speak directly to the industry’s economic and regulatory realities. As the deadline approaches, the special issue stands as both a snapshot and a forecast: a snapshot of a discipline whose techniques have matured into indispensable tools of drug development, and a forecast that the next generation of medicines will be shaped as much by the engineering of particles and the science of formulations as by the discovery of the molecules they deliver.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for dosage form development

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, pharmaceutical dosage forms, Journal of Pharmaceutical Investigation

The scope of the call for papers reads like a map of the modern pharmaceutical development pipeline. The editors are soliciting work on particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies spanning oral, injectable, inhalable, and transdermal dosage forms as well as advanced drug delivery systems; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies for dosage form design and commercial production; and applications of Quality by Design and Process Analytical Technology in formulation and manufacturing. Taken together, these topics describe the full journey of a drug substance from a crystalline powder in a laboratory vial to a reproducible, regulator-approved product made at industrial scale.

Why does particle engineering deserve an entire issue? The answer lies in a stubborn bottleneck that has shaped drug development for decades. A large share of new chemical entities emerging from discovery pipelines fall into the poorly soluble category, meaning they dissolve so slowly or incompletely in the gastrointestinal tract that patients cannot absorb therapeutic doses. A molecule can be extraordinarily potent against its biological target and still fail in the clinic simply because it never reaches the bloodstream in sufficient quantity. Particle engineering attacks this problem at its physical roots: by reducing particle size to the micrometer or nanometer scale, formulators dramatically increase the surface area available for dissolution; by converting a crystalline drug to a amorphous solid dispersion, they sidestep the energetic stability of the crystal lattice that makes dissolution slow in the first place.

The techniques involved are more varied than the phrase particle size reduction might suggest. Milling and jet milling remain workhorses for producing micronized powders, particularly for inhalation products where particle size distribution determines whether a drug deposits in the deep lung or is exhaled again. Supercritical fluid processing, spray drying, and anti-solvent crystallization offer finer control over particle morphology and polymorphic form. Nanocrystal technologies, in which drug particles are stabilized by surfactants or polymers at sizes measured in hundreds of nanometers, have already carried several commercial products to market. Each approach imposes its own trade-offs: amorphous forms dissolve faster but risk reverting to more stable, less soluble crystals during storage; nanoparticles offer high surface area but introduce challenges in filtration, sterilization, and long-term physical stability. The special issue’s emphasis on stability alongside solubility reflects exactly this balancing act.

Solid-state science forms a second pillar of the announced scope. The same molecule can crystallize in multiple polymorphic forms, each with distinct melting points, dissolution rates, and mechanical properties, and regulators require manufacturers to identify and control which form ends up in the product. The most infamous cautionary tale remains ritonavir, an HIV drug that spontaneously began crystallizing in a previously unknown, far less soluble polymorph years after launch, forcing a market withdrawal and a costly reformulation. Modern development therefore leans heavily on techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance to characterize and monitor the solid form of a drug throughout its shelf life. The special issue’s call for work on solid-state characterization and control signals that form selection and form stability remain live research frontiers rather than solved problems.

The word translational in the issue title carries particular weight. Academic formulation research has historically excelled at demonstrating elegant effects at bench scale, only to see those effects evaporate when processes are transferred to pilot plants and commercial manufacturing lines. Scale-up changes everything: mixing dynamics, drying rates, heat transfer, and even the way particles collide and agglomerate shift as equipment grows from grams to hundreds of kilograms. A spray-drying parameter optimized in a laboratory unit may produce a different particle morphology in a production dryer; a wet granulation that behaved predictably in a small bowl may segregate or over-granulate at scale. Translational formulation science, as the editors frame it, is about designing dosage forms and processes with this trajectory in mind from the outset, so that a formulation validated in the laboratory survives the journey through clinical trial supplies to commercial production without losing the performance that made it attractive.

Two regulatory and technological frameworks dominate that translation: Quality by Design and Process Analytical Technology. Quality by Design, embedded in international pharmaceutical development guidelines, asks manufacturers to build scientific understanding into the process itself, identifying the critical quality attributes of a product and the critical process parameters that control them, then designing a design space within which the process can operate flexibly while still guaranteeing quality. Process Analytical Technology supplies the real-time eyes for that approach: near-infrared spectroscopy, Raman spectroscopy, and other inline or atline sensors that monitor blend uniformity, granule moisture, tablet hardness, or crystal form as manufacturing proceeds, rather than relying solely on end-product testing of finished batches. Together they promise a shift from testing quality into a product to designing and monitoring quality into the process, and the special issue explicitly invites contributions on both.

The breadth of dosage forms covered in the call reflects how diversified drug delivery has become. Oral solid dosage forms, from immediate-release tablets to modified-release matrices, still dominate the market, but biologics and potent molecules have pushed injectable formulations, including long-acting depots and nanosuspensions, into greater prominence. Inhalable products demand exquisitely tight particle size control and device-formulation interplay. Transdermal systems bypass first-pass metabolism and improve adherence for drugs suited to skin permeation. Each route imposes distinct demands on particle properties, excipient selection, and manufacturing technology, and the editors’ decision to span all of them suggests they see particle engineering as a unifying discipline rather than a niche technique tied to any single delivery route.

Emerging manufacturing technologies round out the scope, and this is where the field’s near-term future is most visible. Additive manufacturing, notably three-dimensional printing of dosage forms, has already produced the first FDA-approved printed drug product and opens the door to personalized dosing and complex release architectures that conventional tableting cannot achieve. Continuous manufacturing, which replaces the traditional batch-and-queue model with a seamless flow from powder feed to finished tablet, shortens development timelines and shrinks facility footprints while pairing naturally with inline process analytics. Hot-melt extrusion, electrospinning, and microfluidic crystallization each offer new ways to generate amorphous dispersions, nanofibers, or uniform particles. Contributions on how these technologies move from pilot demonstrations to commercial production will likely form a significant share of the accepted papers.

For researchers, the timeline is concrete: manuscripts are due by June 30, 2026, with publication planned for January 2027 in the Journal of Pharmaceutical Investigation, and the guest editors based at Yonsei University, Pusan National University, and Duksung Women’s University will steer the peer review. For the wider industry, the issue lands at a moment when the pharmaceutical sector faces a convergence of pressures: increasingly insoluble molecules from discovery, a growing share of complex biologics requiring sophisticated delivery vehicles, supply chains under scrutiny, and regulators pushing for real-time assurance of quality. Particle engineering and formulation science sit squarely at the center of those pressures. The medicines of the next decade will succeed or fail not only on the biology of their targets but on the size, shape, and solid form of their particles, and a dedicated venue for translational advances in that discipline is a bet that the field’s next breakthroughs will come from the unglamorous but decisive work of turning molecules into manufacturable medicine.

Subject of Research: Pharmaceutical particle engineering and formulation science for translational dosage form development

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, scale-up, continuous manufacturing, amorphous solid dispersions, dosage forms, Journal of Pharmaceutical Investigation

The first pillar of the issue, particle engineering for solubility, stability, and bioavailability enhancement, addresses one of the most stubborn bottlenecks in the industry. An estimated large fraction of new drug candidates emerging from discovery pipelines are poorly water-soluble, meaning that even a pharmacologically brilliant molecule may never reach therapeutic concentrations in a patient’s bloodstream. Particle engineering attacks this problem at its physical root. By reducing particle size into the micron or nanometer range, formulators dramatically increase the surface area available for dissolution, since the rate at which a solid dissolves is proportional to its exposed surface. Nanocrystal suspensions, for example, can raise the apparent solubility of a drug simply by shrinking its particles, allowing oral doses to be absorbed more completely without chemically altering the molecule itself.

Beyond size reduction, the field manipulates the solid state of the drug. Many active pharmaceutical ingredients exist in multiple crystalline forms, or polymorphs, each with a distinct lattice arrangement and therefore distinct thermodynamic properties. A metastable polymorph or an amorphous solid dispersion can be far more soluble than the stable crystal form, but that advantage comes with a risk: the material may spontaneously revert to a less soluble, more stable state during storage, erasing the bioavailability benefit and potentially failing regulatory specifications. Hot-melt extrusion, spray drying, and cryogenic milling are among the techniques used to generate and stabilize these high-energy forms, often by dispersing the drug in a polymeric matrix that kinetically traps it in its amorphous state. The special issue’s call for work on solid-state characterization and control reflects how central this balancing act has become, since a formulation that cannot be proven stable over a two-year shelf life is a formulation that will never reach a pharmacy.

The second major topic, advanced formulation strategies across oral, injectable, inhalable, and transdermal routes, underscores that particle science is not confined to pills. Each route of administration imposes its own engineering constraints. Inhaled medicines, for instance, must deliver particles in a narrow aerodynamic size window, typically one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. That requirement has driven innovations in carrier surface engineering for dry powder inhalers and in the design of propellant-free suspensions for metered-dose devices. Injectable formulations face an entirely different set of demands, including sterility, isotonicity, and the need for some biologics to remain stable in suspension for months. Transdermal systems must push drugs through the stratum corneum, the skin’s formidable lipid barrier, using chemical enhancers, microneedle arrays, or drug-loaded adhesives. The special issue explicitly invites work on advanced drug delivery systems, a category that increasingly includes long-acting injectables and combination products where the device and the formulation must be co-optimized.

What distinguishes this collection from a purely academic exercise is its insistence on translational formulation science and scale-up. The gap between a successful bench experiment and a validated commercial process is notoriously wide. A spray-drying condition that produces beautiful amorphous particles on a laboratory scale may yield inconsistent material when the solvent feed rate, drying gas temperature, and atomization pressure are scaled to industrial throughput. Mixing, granulation, and compression behave differently in large equipment because heat transfer, residence time distribution, and mechanical stress do not scale linearly. Translational research in this context means building formulations with manufacturability in mind from the outset: choosing excipients that are available in pharmaceutical grade, designing processes that tolerate realistic input variability, and generating the stability and performance data that regulators require. The guest editors’ backgrounds in pharmaceutics and drug delivery suggest the issue will favor exactly this kind of end-to-end thinking.

Emerging manufacturing technologies form another pillar of the call for papers, and this is where the field is changing fastest. Continuous manufacturing, in which raw materials flow through connected unit operations without batch interruptions, is steadily displacing traditional batch processing for solid oral doses. Continuous blending, twin-screw hot-melt extrusion, and continuous tableting allow tighter process control and smaller facility footprints, and regulators have increasingly supported the approach because it reduces the risk of human error and enables real-time release testing. Additive manufacturing, better known as three-dimensional printing, has produced dosage forms with geometries impossible to achieve by compression, including printlets with tailored porosity and multi-drug polypills whose release profiles are encoded in their printed structure. These technologies are not laboratory curiosities; several printed and continuously manufactured products have already navigated regulatory pathways, and the special issue’s inclusion of commercial production in its scope signals that the editors want papers describing technologies that are ready, or nearly ready, for the factory floor.

Woven through every topic is the language of Quality by Design and Process Analytical Technology, two paradigms that have reshaped how pharmaceutical development is documented and controlled. Quality by Design, or QbD, inverts the traditional development logic. Instead of testing a finished batch and hoping it passes, developers first define the quality target product profile, identify the critical quality attributes that determine safety and efficacy, and then map how every material attribute and process parameter influences those attributes. The result is a design space, a multidimensional region of operating conditions within which quality is assured, and regulators can approve flexibility to operate anywhere inside it. Process Analytical Technology, or PAT, supplies the real-time eyes for this framework: near-infrared spectroscopy, Raman spectroscopy, and laser diffraction probes mounted directly on production equipment measure blend uniformity, drug concentration, and particle size distribution as the process runs, allowing operators to adjust parameters before a deviation becomes a rejected batch.

The convergence of QbD and PAT with particle engineering is producing a new generation of self-correcting manufacturing systems. In a continuous granulation line equipped with inline spectroscopy, a drift in raw material moisture can be detected within seconds and compensated by adjusting the liquid feed, keeping the granule size distribution inside its approved design space without stopping production. For amorphous solid dispersions, inline Raman monitoring can confirm that the drug remains molecularly dispersed in the polymer rather than recrystallizing during extrusion, a failure mode that is invisible to the naked eye until stability testing reveals it months later. Digital twins, mechanistic process models calibrated with PAT data, are extending this logic further, allowing manufacturers to simulate scale-up on a computer before committing to expensive production campaigns. Papers describing such integrated approaches are precisely what the special issue’s sixth topic is designed to attract.

The significance of this agenda extends beyond engineering efficiency. Formulation science increasingly determines which drugs are commercially viable at all. Biologics, antibody fragments, peptides, and mRNA therapeutics are often fragile molecules that demand sophisticated stabilization strategies, from lyophilization cycles optimized particle by particle to lipid nanoparticle platforms whose size and surface charge dictate cellular uptake. As patent cliffs push the industry toward differentiated generics and 505(b)(2)-style products, the ability to reformulate an existing molecule into a longer-acting, better-tolerated, or more convenient dosage form has become a primary engine of innovation. A drug that can be given once monthly by subcutaneous injection instead of daily by tablet, or inhaled instead of injected, can transform patient adherence and open new markets, and every one of those advances rests on the particle and formulation science this special issue celebrates.

For researchers hoping to contribute, the practical details are clear. Manuscripts are due by June 30, 2026, for publication in the January 2027 issue of the Journal of Pharmaceutical Investigation, and the guest editors welcome contributions across the six announced topics, from fundamental particle characterization to validated commercial manufacturing case studies. The collective message of the call is that the boundary between the pharmacy bench and the production plant has effectively dissolved. The most valuable work in dosage form development today is work that treats a crystal’s lattice energy, a polymer’s glass transition temperature, an extruder’s screw speed, and a regulator’s expectations as parts of a single design problem. The January 2027 issue aims to showcase research that solves that problem end to end, and in doing so, to chart where the next decade of drug delivery will go.

Subject of Research: Translational pharmaceutical dosage form development using particle engineering and formulation science

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solid dispersions, scale-up, Journal of Pharmaceutical Investigation, pharmaceutical manufacturing

The premise behind the initiative is straightforward but consequential. Many of the most promising drug candidates emerging from discovery pipelines fail not because they lack biological activity, but because they dissolve poorly, degrade rapidly, or cannot be manufactured reliably at scale. Formulation science, the discipline that bridges a molecule’s inherent properties and a finished dosage form, has therefore become one of the most strategically important fields in the pharmaceutical industry. By focusing the special issue on particle engineering and formulation science, the editors are inviting contributions that span the entire journey from laboratory bench to commercial production, a journey often described as translational research because it translates scientific insight into therapies that reach patients.

At the heart of the call for papers lies particle engineering, a discipline devoted to designing the physical characteristics of drug particles: their size, shape, crystal form, surface properties, and degree of disorder. These attributes govern how a drug dissolves in the gastrointestinal tract, how deeply it penetrates the lungs when inhaled, how it disperses when injected, and how stable it remains on a pharmacy shelf. Reducing particle size to the micrometer or nanometer scale increases the surface area available for dissolution, which can dramatically improve the oral bioavailability of poorly water-soluble compounds. Industry estimates consistently suggest that a large share of new small-molecule candidates fall into this poorly soluble category, which explains why solubility enhancement has become a dominant theme in pharmaceutical research.

One of the six topic areas named in the call addresses particle engineering approaches for solubility, stability, and bioavailability enhancement. In practice, this encompasses a diverse arsenal of techniques. Milling and high-pressure homogenization can shatter crystals into nanoparticles, while spray drying can lock a drug into an amorphous solid dispersion, a glassy state in which molecules are frozen in random orientations rather than arranged in an orderly crystal lattice. The amorphous form dissolves faster and more completely than its crystalline counterpart, but it carries a vulnerability: given enough time, temperature, or humidity, the molecules tend to revert to the more stable crystal structure, eroding the solubility advantage. That instability leads directly to another topic in the special issue, solid-state characterization and control.

Solid-state science concerns the polymorphic forms a drug molecule can adopt. The same chemical entity can crystallize into multiple arrangements, each with its own melting point, dissolution rate, mechanical behavior, and thermodynamic stability. Regulators expect developers to identify which form is being manufactured and to prove that it remains that form throughout the product’s shelf life. Analytical tools such as powder X-ray diffraction, differential scanning calorimetry, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint these forms and monitor whether unwanted transformations occur during processing. The special issue’s emphasis on solid-state characterization and control reflects a growing recognition that the crystal is not a static backdrop but an active variable in drug performance and regulatory approval.

A second pillar of the call is advanced formulation strategies for pharmaceutical dosage forms and advanced drug delivery systems. The editors explicitly span oral, injectable, inhalable, and transdermal routes, each of which imposes its own engineering constraints. Oral tablets must survive the acidic environment of the stomach and release their payload at the right location. Injectable formulations must be sterile, isotonic, and free of particles that could trigger immune reactions. Inhaled medicines demand aerodynamic particle sizes in a narrow window, typically a few micrometers, so that the droplets or powder particles can reach the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must coax large molecules through a skin barrier that evolved precisely to keep foreign substances out. Conquering any one of these challenges requires a synthesis of materials science, biophysics, and process engineering.

Beyond conventional dosage forms, the call for papers embraces advanced drug delivery systems, a category that includes nanocarriers, controlled-release architectures, and other platforms designed to deliver a drug to the right place at the right time. Such systems can reduce dosing frequency, smooth out dangerous peaks in blood concentration, and concentrate therapeutic effects in diseased tissue while sparing healthy organs. The translational framing of the issue is significant here: elegant delivery concepts abound in academic literature, yet only a fraction ever survive the realities of clinical testing, regulatory scrutiny, and cost-effective mass production. Highlighting translational formulation science and the scale-up of drug products, the special issue explicitly invites research that addresses that difficult passage from proof of concept to patient use.

Scale-up is where many formulation breakthroughs meet their sternest test. A mixing process that works flawlessly in a beaker may behave entirely differently inside a multi-hundred-liter industrial vessel, where heat transfer, shear forces, and drying rates scale non-linearly. Continuous manufacturing, in which product flows steadily through connected unit operations rather than being produced in discrete batches, is emerging as a response to these challenges and fits squarely within the issue’s sixth named topic: emerging manufacturing technologies in dosage form design and commercial production. Additive manufacturing, sometimes described as three-dimensional printing of medicines, hot-melt extrusion, and novel crystallization methods all belong to this conversation, offering ways to create complex dosage forms with properties that conventional equipment cannot achieve.

The final topic area announced by the editors concerns Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT. Quality by Design is a regulatory philosophy, championed by agencies such as the United States Food and Drug Administration, that asks manufacturers to build quality into a product by design rather than testing it in afterwards. Developers systematically map how formulation variables and process parameters affect critical quality attributes, then establish a design space within which the product reliably meets its specifications. Process Analytical Technology provides the sensory apparatus for this vision: real-time instruments such as near-infrared spectroscopy and Raman spectroscopy embedded directly in the production line, monitoring blend uniformity, granule moisture, or tablet hardness without halting the process. Together, QbD and PAT promise shorter development timelines, fewer product failures, and a deeper scientific understanding of why a manufacturing process behaves the way it does.

What unites these six topics is a view of pharmaceutical development as a single, integrated science in which the particle, the formulation, the process, and the patient are inseparable. The January 2027 issue, shaped by guest editors Hwang, Kim, and Park, arrives at a moment when the industry faces an unusually demanding pipeline of biologics, poorly soluble small molecules, and personalized therapies, all of which strain conventional formulation methods. By soliciting work that moves from fundamental particle phenomena to Quality by Design frameworks and commercial-scale production, the Journal of Pharmaceutical Investigation is positioning the special issue as a status report on how the field converts molecular discovery into reliable, manufacturable medicine. Submissions are open until June 30, 2026, and the editors’ collective expertise across formulation technology, physical pharmacy, and drug delivery suggests the resulting collection will speak to academic researchers and industrial scientists alike, precisely the audience charged with making sure that the next generation of drug molecules does not fail for want of a suitable dosage form.

Subject of Research: A special issue of the Journal of Pharmaceutical Investigation on particle engineering and formulation science for pharmaceutical dosage form development

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, quality by design, process analytical technology, pharmaceutical manufacturing, scale-up, dosage forms, solubility enhancement, Journal of Pharmaceutical Investigation

The central problem the field confronts is deceptively simple to state. A majority of drug candidates emerging from modern discovery pipelines are poorly soluble in water, and poor solubility translates directly into poor absorption, erratic exposure in patients, and failed development programs. Particle engineering attacks this problem at its physical root. By manipulating crystal form, particle size, morphology, and surface properties, scientists can transform an intractable molecule into a formulation that dissolves fast enough, stays stable long enough, and manufactures reliably enough to reach pharmacy shelves. The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that these remain the discipline’s defining challenges.

At the heart of particle engineering lies solid-state science. The same molecule can crystallize into multiple polymorphic forms, each with a distinct arrangement of molecules in the solid lattice and, consequently, distinct solubility, melting behavior, mechanical properties, and physical stability. Regulatory agencies require manufacturers to identify and control the relevant solid form because an unanticipated polymorph can undermine a product’s performance, as the industry learned from high-profile cases in which a more stable, less soluble form appeared during production and forced reformulation. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer matrix, trade thermodynamic stability for a dramatic solubility advantage, and controlling the delicate balance between amorphous and crystalline states remains an active frontier of research that the issue’s third listed topic, solid-state characterization and control, addresses directly.

Characterization itself has become a sophisticated, multi-technique enterprise. Powder X-ray diffraction reveals crystal structure, differential scanning calorimetry probes thermal transitions such as glass transition temperatures and melting events, dynamic vapor sorption quantifies hygroscopicity, and spectroscopic methods such as Raman and near-infrared imaging map the spatial distribution of drug and excipient within a dosage unit. Particle size distributions are now routinely characterized not only by laser diffraction but by imaging techniques that capture shape and surface texture, both of which influence flow, blending, and dissolution. The translational challenge is that a formulation optimized at the gram scale in a research laboratory must retain its critical quality attributes when produced in tonnes, and the analytical methods used to assure that consistency must themselves be validated, robust, and in many cases deployed in real time on the factory floor.

That manufacturing dimension is where the special issue’s scope becomes especially forward-looking. Among the topics the editors list are emerging manufacturing technologies in dosage form design and commercial production, a category that encompasses hot-melt extrusion, spray drying, and increasingly additive manufacturing approaches such as three-dimensional printing of dosage forms. Hot-melt extrusion, borrowed originally from polymer processing, melts a drug together with polymeric carriers and shapes the extrudate into tablets, granules, or films, enabling amorphous dispersions to be produced continuously rather than batch by batch. Spray drying, long the workhorse of inhalation powder production, converts a drug solution or suspension into engineered particles with precisely tuned aerodynamic diameters. Continuous manufacturing, in general, is reshaping the economics of pharmaceutical production by replacing sequential batch operations with integrated, steady-state processes that offer tighter control and faster technology transfer from development to commercial scale.

Underpinning much of this industrial evolution is the quality paradigm known as Quality by Design, or QbD, paired with Process Analytical Technology, or PAT. QbD inverts the traditional approach to pharmaceutical quality. Instead of testing finished products to detect defects, developers design formulations and processes around a scientific understanding of which parameters critically affect quality, define a design space within which those parameters may vary, and build control strategies that keep the process inside that space. PAT supplies the sensory apparatus for this philosophy: inline and online instruments, such as near-infrared probes and Raman spectrometers, feed real-time data into process models, allowing operators to monitor blend uniformity, drying endpoints, and granule properties as the process runs rather than waiting for laboratory results. The special issue’s inclusion of QbD and PAT applications reflects how thoroughly these frameworks have moved from regulatory aspiration to daily practice in formulation and manufacturing science.

The breadth of dosage forms covered by the issue is equally telling. The editors invite advanced formulation strategies spanning oral, injectable, inhalable, and transdermal routes, along with advanced drug delivery systems more broadly. Each route imposes its own particle engineering demands. Oral solid dosage forms must survive gastric transit and release drug at the right site and rate. Injectable formulations, particularly the biologic drugs that now dominate pipelines, demand control of aggregation, particulate contamination, and viscosity at high concentrations. Inhaled medicines require particles engineered to aerodynamic diameters of roughly one to five micrometers so they deposit in the lung rather than the throat or the exhaled air, a constraint that has made particle engineering inseparable from inhalation product design. Transdermal systems, whether adhesive patches or microneedle arrays, must overcome the skin’s formidable barrier function while remaining comfortable and manufacturable at scale.

Translational formulation science, the connective tissue of the entire issue, is the discipline of carrying a formulation across the valley that separates discovery from the clinic and the clinic from commerce. Scale-up is rarely a matter of simply making more of a successful laboratory process. Mixing times, heat transfer, shear rates, and drying kinetics all change with equipment size and geometry, and a formulation whose critical quality attributes depend sensitively on any of these variables can fail at scale in ways no bench experiment predicted. Modern practice therefore emphasizes process understanding and modeling from the outset, using tools such as computational fluid dynamics, discrete element modeling of powder behavior, and mechanistic dissolution modeling to anticipate scale effects before they occur. The guest editors’ emphasis on translation suggests the issue will favor work that demonstrates not just novelty at the bench but a credible path to drug product development.

The timing of the call is significant for the broader pharmaceutical ecosystem. Drug pipelines are increasingly dominated by molecules that resist conventional formulation: poorly soluble small molecules, large biologics that cannot survive the digestive tract, and emerging modalities such as RNA therapeutics and gene editing systems that demand entirely new delivery vehicles. Formulation science and particle engineering are the disciplines charged with converting these fragile, difficult molecules into stable, manufacturable, patient-acceptable medicines. Advances in nanosuspensions, lipid nanoparticles, amorphous systems, and controlled-release architectures are therefore not incremental refinements but enabling technologies for entire therapeutic classes. A special issue that gathers solubility enhancement, solid-state control, novel manufacturing, and quality-by-design under one translational umbrella mirrors the way leading development organizations now operate, where formulation scientists, process engineers, and analytical teams work in parallel rather than in sequence.

For researchers considering submission before the June 30, 2026 deadline, the scope outlined by Hwang, Kim, and Park offers a clear signal of the field’s priorities: rigorous science that demonstrably moves dosage forms closer to patients. The Journal of Pharmaceutical Investigation, published by Springer, has positioned itself as a venue where Asian pharmaceutical science and international research communities intersect, and a 2027 issue devoted to translational particle engineering and formulation science is likely to serve as a snapshot of where the discipline stands as continuous manufacturing matures, regulatory frameworks evolve toward real-time quality assurance, and the industry confronts a generation of drug candidates that will succeed or fail on the strength of their formulations. In an era when headlines celebrate molecular targets and clinical breakthroughs, the quieter science of particles, powders, and processes remains the indispensable bridge between a promising molecule and a medicine on the shelf, and the field’s leading practitioners are now documenting exactly how that bridge is built.

Subject of Research: Translational pharmaceutical dosage form development based on particle engineering and formulation science

Article Title: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science

Article References: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: particle engineering, formulation science, drug solubility, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, drug delivery systems, scale-up, amorphous solid dispersions, Journal of Pharmaceutical Investigation