The Journal of Pharmaceutical Investigation has announced a special issue devoted to translational advances in pharmaceutical dosage form development, with a focus on particle engineering and formulation science. 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. Guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, the collection aims to gather research that bridges laboratory-scale innovation and commercial drug product manufacturing, a gap that has long challenged the pharmaceutical industry as molecules emerging from discovery pipelines grow increasingly difficult to formulate.

At the heart of the announced issue lies a problem that has quietly become one of the most consequential in modern medicine: an estimated large fraction of drug candidates in development pipelines suffer from poor aqueous solubility, which limits how much of a compound can dissolve in the gastrointestinal tract and, ultimately, how much reaches the bloodstream. Particle engineering offers a family of techniques designed to attack 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, accelerating the rate at which solid drug particles release their payload into bodily fluids. Techniques such as wet milling, high-pressure homogenization, and spray drying are now standard tools in this effort, and the special issue explicitly invites submissions on particle engineering approaches for solubility, stability, and bioavailability enhancement.

Bioavailability, the proportion of an administered dose that reaches systemic circulation unchanged, depends on a delicate interplay of dissolution, permeability, and stability. A drug that dissolves quickly but precipitates before absorption, or one that degrades in the acidic environment of the stomach, fails patients regardless of how potent it is in a test tube. Formulation scientists respond with an arsenal of strategies: amorphous solid dispersions that trap drug molecules in a disordered, higher-energy state with greater apparent solubility; lipid-based systems that solubilize hydrophobic compounds within digested oil droplets; and complexation approaches that shelter drug molecules inside host structures. Each strategy trades off thermodynamic risk against kinetic benefit, and the stability of these engineered states over a product’s shelf life remains a central preoccupation of the field, one that the guest editors have flagged through their call for work on solid-state characterization and control.

Solid-state science deserves particular attention because the same molecule can exist in multiple crystalline forms, known as polymorphs, each with distinct physical properties. A change in polymorph can alter dissolution rate, mechanical behavior, and chemical stability, sometimes with serious consequences for patients and manufacturers alike. The pharmaceutical industry learned this lesson repeatedly over recent decades, and regulatory frameworks now demand rigorous characterization of crystalline form, hydration state, and particle morphology before approval. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to fingerprint the solid state of a drug substance and monitor whether it remains unchanged through processing, storage, and transport. The special issue’s emphasis on solid-state characterization and control signals that this discipline remains foundational rather than settled, especially as newer modalities complicate the picture.

Beyond small molecules, the scope of the announced issue stretches across delivery routes that demand very different engineering solutions. Oral solid dosage forms, the tablets and capsules that dominate the prescription market, must survive manufacturing stresses and gastric transit while releasing drug at the right place and time. Injectable formulations face sterility, particulate, and compatibility constraints that leave little margin for error. Inhalable products require particles engineered to aerodynamic diameters in the low micrometer range so they can navigate the branching architecture of the respiratory tract and deposit in the lungs. Transdermal systems must push molecules across the skin’s formidable barrier layer, often relying on chemical enhancers, physical energy, or adhesive matrix design. By inviting contributions on advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms alongside advanced drug delivery systems, the editors are framing particle and formulation science as a unified discipline that spans every route of administration.

The translational emphasis in the issue’s title reflects a persistent and expensive bottleneck. A formulation that performs beautifully at the bench may fail when scaled to pilot or commercial production, where mixing times, drying kinetics, and equipment geometries differ fundamentally from laboratory glassware. Scale-up failures can delay drug approvals by months or years and cost manufacturers dearly. Translational formulation science therefore seeks predictive relationships between process parameters and product quality, so that a formulation designed in a beaker can be manufactured reliably in a multi-ton facility. Approaches such as model-informed development, mechanistic modeling of unit operations, and small-scale models that faithfully mimic large-scale equipment have gained traction as ways to de-risk this transition. The call for papers on translational formulation science and scale-up of drug products places this challenge squarely within the issue’s remit.

Emerging manufacturing technologies form another pillar of the announced scope. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than moving in discrete batches, promises tighter control, smaller footprints, and faster response to demand. Additive manufacturing, including various printing technologies, enables dosage forms with complex internal geometries and personalized doses that conventional tableting cannot achieve. Hot-melt extrusion, supercritical fluid processing, and electrospinning each offer distinctive routes to engineered particles and composite structures. These technologies do not merely speed production; they expand the design space of what a dosage form can be, allowing drug release profiles and combinations of actives that were previously impractical. The special issue’s invitation for work on emerging manufacturing technologies in dosage form design and commercial production acknowledges that formulation and process innovation are now inseparable.

Underpinning much of this modern practice are two regulatory and scientific frameworks that have reshaped how drug products are developed. Quality by Design, or QbD, asks developers to define the quality attributes a product must have, identify the formulation and process variables that control those attributes, and build a mechanistic understanding that guarantees quality by design rather than by end-product testing alone. Process Analytical Technology, or PAT, supplies the real-time measurement tools that make this vision operational: near-infrared spectroscopy, Raman spectroscopy, and other inline probes monitor blend uniformity, granulation endpoints, and drying progress as manufacturing proceeds, feeding data to control systems that adjust parameters on the fly. Together, QbD and PAT convert formulation development from an empirical craft into an engineering science, and the explicit inclusion of these applications in the special issue’s topic list underscores how thoroughly they have penetrated both industry practice and regulatory expectations.

The guest editorial team brings complementary perspectives to the project. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research in South Korea, while Min-Soo Kim of Pusan National University is known for work on particle engineering and solubility enhancement technologies, and Heejun Park of Duksung Women’s University contributes expertise in formulation and physical pharmacy. Their joint stewardship suggests an issue that will weigh Asian pharmaceutical research alongside global contributions, fitting for a journal that serves as an international forum for pharmaceutical investigation. Researchers intending to contribute face a June 30, 2026 deadline, with the assembled collection slated to appear in January 2027.

For an industry confronting an ever-greater share of poorly soluble, biologic-adjacent, and otherwise challenging molecules, the questions this special issue addresses are not academic. Every percentage point of bioavailability recovered through smarter particle design translates into lower doses, smaller pills, fewer side effects, and sometimes the difference between a viable medicine and an abandoned program. Every scale-up failure avoided through better translational science shortens the path from discovery to pharmacy shelf. By consolidating particle engineering, formulation strategy, solid-state control, manufacturing innovation, and quality frameworks into a single collection, the Journal of Pharmaceutical Investigation is staking its January 2027 issue on the proposition that the future of drug delivery will be decided at the level of the particle and the process, long before a therapy ever reaches a patient. Submissions are open now, and the field will be watching to see which advances earn a place in what promises to be a defining snapshot of the discipline.

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

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