Particle Engineering Takes Center Stage as Pharmaceutical Formulation Science Heads Toward Translational Milestone

A major new special issue is set to spotlight how the tiniest particles in medicine can determine whether a drug succeeds or fails in the clinic. The Journal of Pharmaceutical Investigation, published by Springer, 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 will be guest edited by Sung-Joo Hwang of Yonsei University in Korea, Min-Soo Kim of Pusan National University in Korea, and Heejun Park of Duksung Women’s University in Korea, three researchers working at the intersection of formulation design, particle technology, and the practical realities of turning laboratory concepts into manufacturable medicines.

The submission deadline for the issue is June 30, 2026, giving research groups worldwide a defined window to contribute work spanning the full spectrum of dosage form development. The scope is deliberately broad, covering particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms as well as advanced drug delivery systems; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies in dosage form design and commercial production; and applications of Quality by Design and Process Analytical Technology in pharmaceutical formulation and manufacturing. Together, these themes describe the technical backbone of modern pharmaceutics, the discipline that determines how an active molecule becomes a tablet, a capsule, an inhaler, or an injection that patients can actually use.

Why does particle engineering matter so much? The answer lies in a fundamental tension of drug development. Many promising molecules discovered in screening campaigns are poorly soluble in water, and the human body, being largely aqueous, struggles to absorb them. Solubility and dissolution rate are governed in part by particle size, shape, surface area, and crystalline form. Reducing particles to the micrometer or nanometer scale dramatically increases the surface area available for dissolution, and techniques such as milling, spray drying, supercritical fluid processing, and controlled crystallization allow scientists to tune these properties with remarkable precision. A drug that dissolves too slowly may pass through the gastrointestinal tract without ever reaching the bloodstream; a drug engineered into the right particle form can achieve adequate exposure at a lower dose, potentially reducing side effects and manufacturing costs at the same time.

Equally important is the solid state of the drug itself. A single molecule can crystallize into multiple polymorphic forms, each with its own melting point, solubility, stability profile, and mechanical behavior. It can also be rendered amorphous, lacking long-range crystalline order entirely, which often improves apparent solubility but introduces the risk that the material will revert to a more stable crystalline form during storage, changing its performance over time. Solid-state characterization, using methods such as X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic techniques, is therefore not an academic luxury but a regulatory and commercial necessity. The special issue’s explicit inclusion of solid-state characterization and control reflects how central this work has become to ensuring that a medicine made today behaves identically to the one made a decade from now.

The breadth of dosage forms covered in the call for papers mirrors the diversity of modern therapeutics. Oral solid dosage forms remain the workhorse of the pharmaceutical industry, prized for patient convenience and manufacturing scalability, yet they face persistent challenges with poorly soluble compounds and with molecules degraded by stomach acid or first-pass metabolism. Injectable formulations demand sterility, isotonicity, and long-term physical stability, and increasingly involve complex biologics that cannot tolerate the stresses of traditional processing. Inhalable products must generate aerosols with particle sizes in a narrow aerodynamic range, typically around one to five micrometers, so that drug particles deposit in the lungs rather than the mouth or throat. Transdermal systems must push molecules across the skin’s formidable barrier layer at controlled rates. Each of these routes imposes its own particle and formulation requirements, and advances in one domain frequently cross-pollinate the others.

The emphasis on translational formulation science and scale-up addresses one of the most difficult transitions in the industry: the leap from a formulation that works in a beaker to one that can be produced reliably in millions of units. A process that mixes well at laboratory scale may behave entirely differently in a thousand-liter vessel, where heat transfer, shear forces, and drying kinetics change dramatically. Crystallization outcomes can shift with vessel geometry and agitation; granulation endpoints can drift with equipment wear; spray-dried powders can vary with nozzle design and drying-air profiles. Translational science in this context means understanding the underlying physics and chemistry deeply enough to predict and control these scale-dependent behaviors, so that the clinical performance demonstrated in early trials is preserved in commercial production.

This is where Quality by Design and Process Analytical Technology enter the picture. Quality by Design, often abbreviated as QbD, is a regulatory and scientific philosophy that treats quality not as something tested into a product at the end of the line, but as something built into it from the start. Rather than fixing a formulation and process by trial and error, QbD asks developers to identify the critical quality attributes of a product, the material attributes and process parameters that affect them, and the design space within which those parameters can vary while still delivering consistent quality. Process Analytical Technology, or PAT, supplies the real-time measurement tools that make this vision practical: near-infrared spectroscopy to monitor blend uniformity, Raman spectroscopy to track polymorphic transformations, and inline particle sizing to follow crystallization as it happens. Together, QbD and PAT allow manufacturers to understand and control their processes continuously rather than discovering problems in finished-product testing, an approach regulators worldwide have encouraged for nearly two decades.

Emerging manufacturing technologies form another pillar of the special issue’s scope. The industry has been steadily adopting continuous manufacturing, in which raw materials flow through connected unit operations to produce finished dosage forms without the batch-based stops and starts of traditional factories. Continuous processes offer tighter control, smaller equipment footprints, and the potential for flexible, on-demand production. Additive manufacturing, including various forms of 3D printing, has opened the possibility of dosage forms with intricate internal geometries that control release kinetics in ways conventional compression cannot achieve. Hot-melt extrusion, electrospinning, and advanced coating technologies likewise expand the formulation scientist’s toolkit. Each of these platforms depends on rigorous particle and materials science to succeed, which is precisely why their development and their formulation foundations are being considered together in a single issue.

The guest editorial team brings complementary perspectives to this agenda. Sung-Joo Hwang’s affiliation with Yonsei University places him within one of Korea’s leading research universities, with a record of work on drug delivery systems and pharmaceutical development. Min-Soo Kim at Pusan National University and Heejun Park at Duksung Women’s University likewise represent active Korean pharmaceutics research groups. The concentration of Korean institutions among the editors reflects the country’s growing prominence in pharmaceutical sciences and manufacturing innovation, and the Journal of Pharmaceutical Investigation, as an international journal rooted in that community, is positioned to draw contributions from Asia, Europe, and the Americas alike. The January 2027 issue date positions the collection to capture work that will be presented and refined across the intervening conference seasons.

For researchers, the announcement is a call to submit; for the wider pharmaceutical community, it is a snapshot of where the field believes its future lies. The unifying thread across all six listed topics is the conviction that dosage form development is no longer an empirical, trial-and-error craft but a quantitative, science-driven engineering discipline. Molecules are increasingly designed with their delivery challenges in mind, particles are engineered rather than merely produced, processes are monitored and modeled rather than merely run, and quality is designed in rather than inspected in. As poorly soluble molecules, biologics, and personalized therapies continue to test the limits of conventional formulation, the kind of integrated particle engineering and formulation science this special issue will gather becomes not just useful but indispensable. The June 30, 2026 deadline will mark the moment when the field’s latest translational advances begin converging toward a single, comprehensive view of how modern medicines are made.

Subject of Research: A special issue of the Journal of Pharmaceutical Investigation on particle engineering and formulation science in 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

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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, bioavailability, pharmaceutical manufacturing, dosage forms