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

A new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation, with a publication date scheduled for January 2027 and a submission deadline of June 30, 2026. The issue, tentatively titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, is being curated by three guest editors based in South Korea: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Its stated ambition is to bridge a gap that has long frustrated the pharmaceutical industry: the distance between an elegant formulation demonstrated in a laboratory and a dosage form that can be reliably manufactured, regulated, and delivered to patients at scale.

The timing of such a collection is hardly accidental. A large share of drug candidates emerging from discovery pipelines today are poorly soluble in water, a property that undermines their absorption in the gastrointestinal tract and complicates nearly every downstream decision in development. Particle engineering has become one of the most powerful responses to this challenge. By manipulating crystal form, particle size, size distribution, and surface characteristics, formulation scientists can dramatically alter how a drug dissolves, how stable it remains on the shelf, and how much of an administered dose actually reaches the bloodstream. The special issue explicitly invites contributions on particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that these foundational questions remain far from settled.

The technical logic behind particle engineering rests on well-established physical chemistry. According to the Noyes-Whitney equation, the rate at which a solid dissolves is proportional to its surface area, so reducing particle size into the micrometer and nanometer ranges increases the interfacial area available for dissolution. Nanocrystal stabilization, typically achieved with polymers or surfactants that prevent the high-energy particles from aggregating, has already produced marketed products, yet questions about long-term physical stability, Ostwald ripening, and the behavior of nanosuspensions in biological fluids continue to drive research. At the same time, solid-state interventions such as amorphous solid dispersions trade crystalline stability for apparent solubility, creating a persistent tension: the very thermodynamic instability that makes an amorphous form dissolve faster also makes it prone to recrystallization during storage. Controlling that balance is one of the central problems the field continues to wrestle with.

Polymorphism adds another layer of complexity. Many organic molecules can crystallize in multiple forms, each with a distinct lattice energy and therefore distinct solubility, melting point, mechanical behavior, and stability profile. Regulatory agencies require manufacturers to identify and control the crystal form of an active ingredient because an unintended transformation during processing or storage can alter product performance. The special issue’s call for work on solid-state characterization and control reflects this reality. Modern analytical tools, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy, allow scientists to detect subtle transformations that would have been invisible a generation ago. The challenge now is translating that analytical sensitivity into process control, ensuring that milling, drying, granulation, and compression steps do not silently convert one form into another.

Beyond the solid oral dosage forms that dominate the market, the special issue casts a deliberately wide net across delivery routes. It invites advanced formulation strategies for oral, injectable, inhalable, and transdermal products, among others, along with broader advanced drug delivery systems. Each route imposes its own demands. Inhaled medicines require particles engineered to aerodynamic diameters in the range of roughly one to five micrometers so they can reach the deep lung, and their performance depends on the interplay between the formulation and the inhaler device. Injectable formulations must balance concentration, osmolality, viscosity, and sterility while avoiding precipitation at the injection site. Transdermal systems must coax molecules across a skin barrier that evolution designed to keep them out, often relying on chemical permeation enhancers, microneedle arrays, or engineered vesicles. The diversity of these challenges is precisely why formulation science resists one-size-fits-all solutions.

Perhaps the most distinctive emphasis of the forthcoming issue is its insistence on translation and scale-up. Laboratory-scale successes routinely fail when transferred to pilot or commercial manufacturing equipment, because processes such as spray drying, hot-melt extrusion, high-shear wet granulation, and fluid-bed coating behave differently at larger volumes. Heat and mass transfer, residence time distributions, and shear forces do not scale linearly, and a formulation that performed beautifully in a one-kilogram batch may segregate, degrade, or lose its dissolution advantage in a production-scale run. By dedicating a topic to translational formulation science and scale-up of drug products, the editors are acknowledging that the path from bench to market is a scientific discipline in its own right, deserving of rigorous publication rather than being treated as an industrial afterthought.

Emerging manufacturing technologies form another pillar of the call for papers. Continuous manufacturing, in which raw materials flow through interconnected unit operations without batch interruptions, is steadily gaining ground in pharmaceutical production because it offers tighter control, smaller footprints, and the potential for real-time release testing. Additive manufacturing, best known in the form of three-dimensional printing, has demonstrated the ability to produce dosage forms with complex internal geometries and personalized doses, an approach that captured global attention when the first printed drug product received regulatory approval. Other technologies, including electrospinning for nanofibrous carriers, supercritical fluid processing for solvent-free particle formation, and microfluidic methods for producing highly uniform lipid-based carriers, are expanding the toolbox available to formulators. The special issue’s inclusion of commercial production among its interests suggests it wants to see these technologies assessed not as laboratory curiosities but as viable industrial platforms.

Woven through the entire call is the language of modern pharmaceutical quality: Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT. QbD is a regulatory philosophy that asks developers to build quality into a product by design rather than testing it in afterward. In practice, this means systematically identifying the critical material attributes of a formulation and the critical process parameters of its manufacture, then establishing a design space within which those variables can vary without compromising quality. PAT supplies the sensory apparatus for this approach: near-infrared spectroscopy, Raman spectroscopy, and other inline or at-line measurement techniques allow manufacturers to monitor blend uniformity, granule moisture, tablet hardness, or crystal form in real time, feeding the data into control systems that adjust the process on the fly. Together, QbD and PAT have reshaped how regulators and manufacturers think about pharmaceutical development, and the special issue’s explicit invitation for applications in formulation and manufacturing underscores how central they have become.

For researchers and industry scientists, the practical details of participation are straightforward. Manuscripts are due by June 30, 2026, with the issue slated for January 2027, giving contributors roughly a year and a half to prepare submissions. The guest editors, whose combined affiliations span Yonsei University, Pusan National University, and Duksung Women’s University, represent a Korean pharmaceutical science community that has been increasingly visible in drug delivery research, from amorphous formulations and nanosuspensions to transdermal and orally disintegrating technologies. Their editorial stewardship suggests the issue will balance fundamental physical science with application-oriented studies, a combination that mirrors how the field actually operates.

The broader significance of such a collection lies in what it says about where drug development is heading. As biologics, antibody-drug conjugates, RNA therapeutics, and other complex modalities join the pipeline alongside traditional small molecules, the demand for sophisticated dosage forms is only intensifying. A molecule that cannot be formulated into a stable, manufacturable, patient-acceptable product is, in commercial and clinical terms, a failure regardless of its biological promise. Particle engineering and formulation science are the disciplines that convert molecular promise into medicine, and the Journal of Pharmaceutical Investigation’s decision to devote a special issue to their translational advances is a recognition that the hardest problems in pharmaceutics are no longer confined to the bench. They live on the manufacturing floor, in regulatory dossiers, and ultimately in the hands of patients, which is exactly where this collection aims to push the science.

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, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, scale-up, continuous manufacturing, nanocrystals, amorphous solid dispersions, Journal of Pharmaceutical Investigation