Particle Engineering and Formulation Science Drive the Next Generation of Drug Delivery

Pharmaceutical science is preparing for a major collective stocktaking of how medicines are physically designed, manufactured, and translated from laboratory bench to patient bedside. The Journal of Pharmaceutical Investigation has announced a special issue titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, scheduled for publication in January 2027. The issue, curated by guest editors Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, is soliciting contributions across the full breadth of modern dosage form science, with a submission deadline of June 30, 2026. Although a call for papers might seem like an administrative event, the scope of this issue reads like a map of the most consequential unsolved problems in drug delivery, and it signals where the field believes its next decade of breakthroughs will come from.

At the heart of the announced agenda is particle engineering, the discipline of manipulating the physical attributes of drug particles, including size, shape, morphology, crystallinity, and surface properties, to achieve therapeutic objectives. The rationale is deceptively simple: most small-molecule drugs in the development pipeline are poorly soluble in water, and a molecule that cannot dissolve cannot be absorbed, no matter how potent it is in a test tube. Particle engineering attacks this problem at its physical root. Reducing particle size to the micrometer or nanometer scale dramatically increases the surface area available for dissolution, following the classical Noyes-Whitney relationship that governs dissolution rate. Beyond size reduction, scientists can convert a drug from its thermodynamically stable crystalline form into a higher-energy amorphous state, which dissolves faster because the crystal lattice no longer must be torn apart before molecules can escape into solution. Each of these strategies trades a gain in solubility against new risks in physical stability, since amorphous materials tend to recrystallize over time and fine particles tend to aggregate.

The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, which places the solubility-stability trade-off at the center of the discussion. This tension is one of the defining challenges of contemporary formulation science. A formulator can often achieve spectacular dissolution in a beaker, but the same material may fail months later on a stability shelf, or may behave unpredictably as it traverses the gastrointestinal tract, where pH shifts from acidic in the stomach to near-neutral in the intestine. Translational success therefore requires not just generating a favorable particle population but understanding and controlling how that population evolves under stress, humidity, temperature cycling, and mechanical agitation. Contributions that bridge this gap between laboratory-scale ingenuity and real-world robustness are precisely what the guest editors appear to be seeking, and the field has been waiting for a consolidated venue to showcase them.

The second pillar of the announced scope is advanced formulation strategy across an unusually wide range of administration routes. The call names oral, injectable, inhalable, and transdermal dosage forms, along with advanced drug delivery systems more broadly. Each route imposes its own physical demands on a formulation. Oral solid dosage forms, still the dominant commercial format, must survive manufacturing stresses such as compression and coating, then disintegrate and dissolve in the digestive tract. Injectable formulations must be sterile, isotonic or carefully tolerated, and free of particles that could embolize capillaries, which makes particle size control a safety issue rather than merely a performance one. Inhalable products must generate aerosol droplets or particles in a narrow aerodynamic diameter range, typically around one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push drug molecules through the stratum corneum, the skin’s remarkably effective lipid barrier, often relying on supersaturation, penetration enhancers, or engineered adhesives. A single special issue covering all of these routes reflects a conviction that the underlying physics of particles and formulations is shared, even when the applications diverge.

Solid-state characterization and control form the third announced theme, and this is where modern pharmaceutical development has been transformed most visibly by analytical instrumentation. A drug substance can exist in multiple crystalline polymorphs, each with a distinct arrangement of molecules in the lattice and, consequently, distinct solubility, melting point, mechanical behavior, and stability profile. The regulatory and commercial stakes of polymorphism are legendary in the industry, because an unintended transformation during manufacture or storage can alter dissolution behavior and, in principle, therapeutic performance. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, solid-state nuclear magnetic resonance spectroscopy, and Raman microscopy allow scientists to identify which solid form is present, quantify mixtures of forms, and detect trace conversions before they become product failures. The special issue’s emphasis on control, not merely characterization, points toward process strategies that maintain a desired solid form throughout the product lifecycle, from crystallization in the API plant to the final packaged tablet.

Translational formulation science and scale-up constitute the fourth theme, and arguably the one that most directly determines whether patients ever benefit from laboratory discoveries. A formulation that performs beautifully at the one-gram scale can behave entirely differently at the hundred-kilogram scale, because mixing times, heat transfer, drying kinetics, and shear forces all change with equipment geometry and batch size. Wet granulation, spray drying, hot-melt extrusion, and high-shear blending each have scale-up quirks that have derailed otherwise promising development programs. Translational science in this context means building predictive bridges between small-scale experiments and commercial manufacturing, often through dimensionless engineering analysis, computational fluid dynamics modeling, and statistically designed experiments that identify which process parameters actually govern critical quality attributes. The guest editors’ decision to foreground translation suggests they want submissions that demonstrate this bridge explicitly, showing not just what works but how it was carried across the scale divide.

Emerging manufacturing technologies form the fifth announced topic, and this is the arena where the field’s most publicized innovations are currently unfolding. Continuous manufacturing, which replaces the traditional batch-and-warehouse model with a seamless flow of material through connected unit operations, promises shorter production times, smaller facility footprints, and tighter quality control, and regulators in the United States, Europe, and Asia have actively encouraged its adoption. Additive manufacturing, including various 3D printing platforms, enables dosage forms with complex internal geometries and personalized doses that conventional tableting cannot achieve. Other emerging approaches include electrospinning for nanofibrous drug carriers, supercritical fluid technologies for producing solvent-free engineered particles, and microfluidic methods for generating highly uniform nanoparticles and lipid carriers. The special issue’s inclusion of commercial production in this topic is notable, because it asks not only for novel laboratory demonstrations but for technologies that have proven, or can plausibly prove, their worth under the unforgiving economics and quality expectations of industrial pharmaceutical production.

The sixth theme, applications of Quality by Design and Process Analytical Technology, ties the entire agenda together with a regulatory and philosophical framework. Quality by Design, usually abbreviated QbD, inverts the traditional approach to pharmaceutical quality. Instead of testing finished products to catch defects, QbD asks developers to understand their formulation and process so thoroughly that they can design quality into the product from the start, identifying critical material attributes and critical process parameters and establishing a design space within which the product reliably meets its specifications. Process Analytical Technology, or PAT, supplies the real-time sensory apparatus for this vision: inline and online probes based on near-infrared spectroscopy, Raman spectroscopy, and other techniques that monitor blend uniformity, granule moisture, tablet hardness proxies, or particle size distributions as the process runs, allowing feedback control rather than end-point guesswork. Together, QbD and PAT have reshaped regulatory expectations for new drug applications, and the special issue’s explicit invitation for work in this area acknowledges that no modern formulation advance is complete without a quality strategy that regulators can evaluate.

The composition of the guest editorial team offers its own signal about the issue’s orientation. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research in South Korea, and Min-Soo Kim of Pusan National University is known for work in particle engineering and physical pharmacy, while Heejun Park of Duksung Women’s University contributes expertise in formulation development. The concentration of Korean academic leadership reflects the Journal of Pharmaceutical Investigation’s roots and its role as a prominent English-language venue for pharmaceutical science in Asia, while the international scope of the announced topics makes clear that submissions from researchers worldwide are the intended audience. For early-career scientists in particular, a themed issue of this kind functions as a curated snapshot of what leading formulation scientists consider important, publishable, and translational, which can shape research agendas and funding proposals for years.

For the broader scientific readership, the significance of this special issue lies in what it reveals about the state of drug delivery. The era in which a new molecule alone could carry a drug to market is fading; an increasing share of therapeutic value now comes from how a molecule is formulated, what solid form it takes, how its particles are engineered, and how reliably its manufacture can be scaled and controlled. The announced themes collectively describe a field that has matured from empirical trial and error into a quantitative, design-driven engineering discipline, one that borrows from materials science, chemical engineering, analytical chemistry, and regulatory science in equal measure. Researchers working on solubility enhancement, novel dosage forms, solid-state control, continuous manufacturing, or QbD-based development now have a defined target: submissions are due by June 30, 2026, for publication in January 2027, and the resulting collection is positioned to become a reference point for anyone tracking how the medicines of the next decade will be physically built.

Subject of Research: Particle engineering and formulation science for pharmaceutical dosage form development

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, continuous manufacturing, scale-up, dosage forms, pharmaceutics, special issue