The special issue is being curated by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three researchers whose institutions anchor a substantial portion of Korea’s pharmaceutical formulation research enterprise. Their editorial mandate is explicitly translational, a word that carries significant weight in a field often criticized for producing elegant laboratory results that never survive the journey to the clinic or the factory floor. By framing the call around translation, the editors are signaling that they want work which addresses not only whether a formulation can be made to function in a beaker, but whether it can be characterized, scaled, regulated, and reproduced at industrial scale without losing the properties that made it attractive in the first place.

At the heart of the announced scope sits particle engineering, the discipline concerned with deliberately designing the physical attributes of drug particles—size, shape, morphology, crystal form, surface properties, and degree of aggregation—to achieve specific therapeutic and manufacturing outcomes. The topic list published with the call highlights particle engineering approaches for solubility, stability, and bioavailability enhancement, which together describe the central triad of problems that plague poorly soluble drug candidates. An estimated large fraction of new chemical entities emerging from discovery pipelines suffer from inadequate aqueous solubility, meaning that even a pharmacologically potent molecule may be absorbed so poorly that it fails to reach therapeutic concentrations in the bloodstream. Particle engineering responds to this challenge by manipulating matter at scales from nanometers to hundreds of micrometers, using techniques such as micronization, nanocrystal formation, amorphous solid dispersion, and controlled crystallization to increase the effective surface area and dissolution rate of a drug substance.

The physics underlying these approaches is deceptively simple in principle and notoriously difficult in practice. According to the Noyes-Whitney relationship, dissolution rate scales with the surface area of the dissolving solid, so reducing particle size increases the rate at which a drug enters solution. But shrinking particles also raises their surface free energy, which drives them to aggregate, and it can destabilize the solid state itself, converting a stable crystalline form into a metastable amorphous material that may recrystallize unpredictably during storage. The special issue’s emphasis on solid-state characterization and control acknowledges precisely this tension. Polymorphism—the ability of a molecule to pack into multiple distinct crystal structures—remains one of the most consequential and least predictable phenomena in pharmaceutical development, because different polymorphs can exhibit different solubility, stability, mechanical behavior, and even patent status. Rigorous analytical methods, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy, are essential to demonstrating that a chosen solid form remains the chosen solid form from first synthesis through shelf life.

Beyond the particle itself, the call for papers spans advanced formulation strategies for essentially every route of administration a modern patient might encounter: oral, injectable, inhalable, and transdermal, among others, together with advanced drug delivery systems. Each route imposes its own engineering constraints. Oral dosage forms must survive the acidic environment of the stomach and the enzymatic gauntlet of the gastrointestinal tract before releasing their payload at the right location and rate. Injectable formulations must meet stringent requirements for sterility, isotonicity, and the absence of particulate contamination, and increasingly they must stabilize delicate biologics such as proteins and peptides that denature under stress. Inhalable products demand exquisitely controlled aerodynamic particle size distributions, typically in the range of one to five micrometers, so that drug particles deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must coax molecules across the stratum corneum, the skin’s remarkably effective barrier, often requiring permeation enhancers or engineered vehicles. A formulation scientist working across these domains must therefore be fluent in fluid dynamics, interfacial chemistry, polymer physics, and biopharmaceutics simultaneously.

Perhaps the most forward-looking section of the announced scope concerns translational formulation science and the scale-up of drug products, the stage at which more development programs falter than anywhere else. A mixing process that produces a uniform suspension in a two-liter laboratory vessel may generate dead zones, excessive shear, or uncontrolled temperature gradients in a two-thousand-liter manufacturing tank. Drying kinetics, granulation behavior, and powder flow properties all change with scale in ways that are only partially captured by current engineering models. The translational framing of this special issue invites contributions that confront these realities directly: studies that track how a formulation’s critical quality attributes evolve from bench to pilot to commercial scale, and methodologies for predicting, rather than discovering, those changes. In an era when regulatory agencies increasingly expect sponsors to justify their manufacturing choices with mechanistic understanding, work that bridges the laboratory-to-plant divide has both scientific and commercial urgency.

Closely allied to scale-up is the final pair of topics on the editors’ list: 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. Quality by Design, often abbreviated as QbD, represents a philosophical shift in how medicines are made. Rather than testing finished products to catch defects, QbD asks developers to identify the parameters that genuinely matter to product quality, understand how those parameters interact, and build a design space within which the product is guaranteed to meet its specifications. Process Analytical Technology, or PAT, supplies the sensory apparatus for this philosophy: inline and online instruments such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement that allow manufacturers to monitor critical attributes in real time during production rather than waiting for laboratory results. Together, QbD and PAT enable continuous manufacturing, a paradigm that replaces the traditional batch-based approach with a steady-state process that can respond dynamically to variations in raw materials and operating conditions.

Emerging manufacturing technologies extend this modernization agenda into territory that would have seemed speculative only a decade ago. Additive manufacturing, commonly known as three-dimensional printing, has already demonstrated the capacity to produce oral dosage forms with internally complex architectures that control release kinetics in ways conventional compression cannot match, and to personalize dose strength for individual patients. Hot-melt extrusion, electrospinning, supercritical fluid processing, and microfluidic nanomanufacturing each offer routes to drug presentations that were previously inaccessible. The special issue’s willingness to consider such technologies alongside established unit operations suggests that the editors see formulation science as a continuum in which new process capabilities and new dosage form concepts co-evolve, each enabling the other.

The timing of the initiative, with submissions due by the end of June 2026 and publication in January 2027, positions the issue to capture a field in rapid transition. The pharmaceutical industry is simultaneously absorbing a wave of modalities—messenger RNA, antibody-drug conjugates, gene therapies, and high-concentration biologics—that stress traditional formulation paradigms to their limits, while facing persistent pressure to improve the bioavailability of small molecules that discovery chemistry keeps producing. Particle engineering and formulation science sit at the intersection of these pressures, and the guest editors’ decision to organize the issue around translation rather than technique reflects a growing consensus that the discipline’s value is measured not in publications but in medicines that reach patients reliably, affordably, and at scale.

For researchers considering submission, the scope published by the Journal of Pharmaceutical Investigation offers a clear map of what the field’s leading voices consider the live frontiers: solubility and bioavailability enhancement through engineered particles, formulation strategies across every major delivery route, solid-state characterization and control, translational scale-up, emerging manufacturing technologies, and the QbD and PAT frameworks that bind them together. Whether the resulting issue becomes a snapshot of a discipline or a catalyst for its next phase will depend on the community’s response, but the ambition is unmistakable. The humble pill, the prefilled syringe, and the dry powder inhaler are, in truth, among the most sophisticated engineered objects in modern healthcare, and the scientists who design them are now being asked to prove it at every stage from molecule to market.

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

DOI: Not provided

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