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