Particle Engineering Takes Center Stage as Drug Formulation Science Pushes Toward the Clinic

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. Scheduled for publication in January 2027, the issue will be guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three Korean researchers whose work spans the interface between laboratory formulation design and the industrial realities of drug product manufacturing. The call for papers sets a submission deadline of June 30, 2026, and invites contributions across six broad thematic areas that together map the technical journey a molecule must travel from discovery bench to medicine cabinet.

The first of those themes, particle engineering approaches for solubility, stability, and bioavailability enhancement, addresses one of the most persistent bottlenecks in modern pharmacology. A large proportion of drug candidates emerging from high-throughput screening are poorly soluble in water, which limits how much of an orally administered dose can actually reach the bloodstream. Particle engineering tackles this problem by changing the physical characteristics of the drug substance itself rather than its chemical structure. Techniques such as micronization and nanonization increase the surface area available for dissolution, while controlled crystallization and amorphous solid dispersion can convert a stubbornly crystalline compound into a form that dissolves more readily. Because dissolution rate depends on surface area, particle size distribution, and the thermodynamic state of the solid, manipulating these parameters can transform a molecule that fails in preclinical testing into one that performs adequately in patients.

The second theme broadens the view from the particle to the finished product, covering advanced formulation strategies for oral, injectable, inhalable, transdermal, and other dosage forms, along with advanced drug delivery systems. Each route of administration imposes its own demands. Oral tablets must survive stomach acid and release their payload at the right point in the intestine. Injectable formulations must be sterile, isotonic, and stable in solution or suspension for their entire shelf life. Inhaled products depend on aerodynamic particle size, typically in the range of one to five micrometers, to deposit medication in the lungs rather than the throat. Transdermal patches must balance drug flux through the skin barrier against patient comfort and adhesive performance. Formulation science provides the toolbox for meeting these constraints, drawing on polymers, lipids, surfactants, and cyclodextrins to build delivery systems that protect fragile molecules, target specific tissues, or sustain release over hours and days.

Solid-state characterization and control, the third theme, underpins nearly everything else in the field. The same molecule can crystallize into multiple polymorphic forms, each with a distinct melting point, solubility, and tendency to convert into other forms over time. Regulatory agencies require manufacturers to identify which form is present in a drug product and to demonstrate that it remains that form throughout the product’s shelf life, because an unintended transition to a more stable, less soluble polymorph can quietly reduce bioavailability. Hydrates and solvates add further complexity, as does the amorphous state, which offers superior solubility but a thermodynamic drive to recrystallize. Characterization techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint these states, while process controls keep them from drifting during manufacture and storage.

The fourth theme, translational formulation science and scale-up of drug products, is where many promising laboratory formulations meet their hardest test. A dispersion prepared in a beaker may behave perfectly at milliliter scale, yet prove impossible to reproduce in a two-thousand-liter manufacturing vessel where mixing times, heat transfer, and shear forces differ dramatically. Translational research in this area seeks to identify which formulation variables actually govern product performance and to design processes that preserve those variables as batch size increases. This work is especially critical for emerging modalities such as amorphous dispersions produced by hot-melt extrusion, lipid nanoparticles for nucleic acid delivery, and high-concentration biologics for subcutaneous injection, all of which are sensitive to processing conditions in ways that conventional tablets are not.

Emerging manufacturing technologies form the fifth theme, reflecting a period of rapid change in how dosage forms are designed and produced. Continuous manufacturing, in which raw materials flow through connected unit operations rather than sitting in discrete batches, offers tighter process control and faster response to demand. Additive manufacturing, commonly known as three-dimensional printing, makes it possible to build dosage forms with internal geometries that control release kinetics in ways compression cannot achieve. Other technologies on the agenda include electrospinning for nanofibrous drug carriers, supercritical fluid processing for solvent-free particle production, and advanced drying methods that preserve labile biologics. The special issue’s inclusion of commercial production among its interests signals that the editors want papers demonstrating not just laboratory novelty but manufacturability at scale.

The sixth theme, applications of Quality by Design and Process Analytical Technology, connects the scientific content of the issue to its regulatory dimension. Quality by Design, or QbD, is a development philosophy in which manufacturers systematically identify the critical quality attributes of a product and the critical process parameters that control them, then build a design space within which the product reliably meets its specifications. Process Analytical Technology, or PAT, supplies the real-time measurement tools that make this philosophy work in practice, using inline and online sensors such as near-infrared spectroscopy and Raman spectroscopy to monitor blend uniformity, granulation endpoints, and drying progress without stopping the line or pulling samples. Together, QbD and PAT shift quality assurance from testing finished products after the fact to controlling the process as it runs, reducing waste and improving consistency.

The composition of the guest editorial team reflects the interdisciplinary reach of the subject matter. Sung-Joo Hwang’s research at Yonsei University has long addressed pharmaceutical formulation and drug delivery system development, while Min-Soo Kim at Pusan National University works on particle engineering and physical pharmaceutics, and Heejun Park at Duksung Women’s University contributes expertise in formulation and process development. Bringing together editors from three institutions suggests an intent to gather contributions that bridge academic innovation and industrial application, which is precisely what the word translational in the issue’s title promises. The Journal of Pharmaceutical Investigation, published by Springer, serves as a venue for research on pharmaceutical formulation, drug delivery, and the pharmaceutical sciences more broadly, making it a natural home for a collection of this scope.

For researchers considering submission, the six listed topics function as an open invitation to report work that moves formulation concepts closer to patients. A study might describe a new crystallization route that stabilizes a metastable polymorph, a scale-up protocol for a hot-melt extruded dispersion, a PAT sensor strategy for monitoring a continuous granulation line, or a comparative evaluation of inhalation particle engineering methods. What unites these possibilities is the recognition that a drug molecule is only as good as the dosage form that carries it, and that the science of particles, powders, and processes determines whether a therapeutic advance ever reaches the people who need it. With submissions due by the end of June 2026 and publication planned for January 2027, the issue is positioned to capture a snapshot of a discipline in which computational modeling, advanced analytics, and novel manufacturing platforms are converging on the oldest problem in pharmacy: getting the right amount of the right molecule, in the right form, to the right place in the body.

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

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