Particle Engineering Takes Center Stage as Journal Prepares Landmark Drug Formulation Issue

A major new special issue of the Journal of Pharmaceutical Investigation is set to spotlight how particle engineering and formulation science are transforming the way medicines are designed, manufactured, and delivered to patients. The issue, tentatively titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, is scheduled for publication in January 2027, with a submission deadline of June 30, 2026. It will be guided by three guest editors from South Korea: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Together, they are inviting researchers from academia and industry to contribute work that bridges the persistent gap between laboratory-scale innovation and commercially viable drug products.

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

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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