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 focus on how particle engineering and formulation science are being translated from laboratory benches into medicines that patients actually take. The issue, tentatively titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, is scheduled for publication in January 2027, with a submission deadline of June 30, 2026. It will be led by three guest editors from South Korea: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Together, they are inviting contributions that span the full journey of a dosage form, from the first manipulation of a molecule’s solid state to the scaled-up manufacturing lines that produce billions of tablets, capsules, and injectable vials.

The premise behind the issue reflects a quiet crisis in modern pharmacology. Many of the most promising drug candidates discovered in recent decades, particularly the large wave of poorly water-soluble small molecules emerging from high-throughput screening, dissolve so poorly in the gastrointestinal tract that their therapeutic potential is throttled before it begins. Estimates across the pharmaceutical industry have long suggested that a large fraction of new chemical entities fall into the poorly soluble categories of the biopharmaceutics classification system, meaning that absorption is limited not by the biology of the gut but by the physical chemistry of the drug itself. Particle engineering exists precisely to close that gap, reshaping crystals, particles, and surfaces so that a molecule that is stubborn in bulk form becomes bioavailable in the bloodstream.

The techniques involved are more varied than the term might suggest. Micronization and nanonization reduce particle size to increase surface area, accelerating dissolution according to well-established principles of interfacial mass transfer. Amorphous solid dispersions trap drug molecules in a disordered, high-energy glassy matrix, trading thermodynamic stability for a dramatic boost in apparent solubility. Co-crystallization pairs the active molecule with a benign partner to create a new crystal lattice with altered dissolution behavior, while polymorph screening hunts for the crystal habit that offers the best compromise among solubility, mechanical properties, and long-term stability. Each approach carries trade-offs, and the special issue explicitly invites work on how these trade-offs are being managed for solubility, stability, and bioavailability enhancement, the first of its six listed topic areas.

What distinguishes this collection from a purely academic exercise is the word translational. The guest editors are asking not only for novel particle designs but for evidence that those designs survive contact with the real world: regulatory scrutiny, scale-up equipment, and the harsh economics of commercial production. A nanosuspension that performs beautifully in a beaker is of little value if it cannot be milled reproducibly at kilogram scale, if its particles agglomerate during storage, or if its dissolution profile drifts outside specification between batches. Translational formulation science, as the issue frames it, is the discipline of anticipating those failures early and engineering them out before a product reaches the plant floor or, worse, the pharmacy shelf.

The scope of dosage forms under consideration is deliberately broad. The call lists oral, injectable, inhalable, and transdermal formulations among others, alongside advanced drug delivery systems. Each of these routes imposes its own particle-level demands. Inhaled medicines require particles engineered to a precise aerodynamic diameter, typically in the range of one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable formulations must balance particle size and rheology against sterility and tolerability, with submicron carriers such as liposomes and polymeric nanoparticles opening new possibilities for targeted delivery and sustained release. Transdermal systems depend on formulation strategies that push molecules across the skin’s formidable barrier, often relying on particle-level manipulation of drug thermodynamic activity. Oral solid dosage forms, still the workhorse of the industry, tie all of these threads together through tablet engineering, coating technology, and controlled-release architecture.

Solid-state characterization and control form another pillar of the issue. The same molecule can crystallize into multiple polymorphs, each with distinct melting points, dissolution rates, and mechanical behavior, and regulatory history is full of cases where an unanticipated polymorph transition compromised a marketed product. Modern characterization tools, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy, allow scientists to fingerprint the solid form of a drug with remarkable precision. The challenge is turning that analytical power into control: understanding which forms appear under which processing conditions, predicting how they will transform over a product’s shelf life, and designing manufacturing steps that lock in the desired state. Contributions that advance this predictive understanding of solid-state behavior are explicitly within the issue’s scope.

Manufacturing technology represents a third major theme. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than moving batch by batch between disconnected steps, has been one of the most significant shifts in pharmaceutical production in recent decades. Hot-melt extrusion, spray drying, and emerging techniques such as additive manufacturing of dosage forms all change how particles are formed and how formulations are assembled, and each demands new approaches to process understanding and quality assurance. The issue’s call for papers on emerging manufacturing technologies in dosage form design and commercial production signals an interest in work that connects these engineering advances to the formulations themselves, rather than treating the factory as an afterthought to the laboratory.

Woven through the entire enterprise are the quality paradigms of Quality by Design and Process Analytical Technology, the final two topic areas listed by the editors. Quality by Design inverts the traditional approach to pharmaceutical quality: instead of testing finished products to catch defects, developers build scientific understanding of how formulation variables and process parameters affect critical quality attributes, then design a design space within which the product is guaranteed to meet specifications. Process Analytical Technology supplies the sensory apparatus for that vision, using inline and at-line tools such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement to monitor particle size, composition, and solid form in real time during production. Together, these frameworks turn formulation development from an empirical craft into a quantitative engineering discipline, and they have become expectations rather than options in regulatory submissions across major markets.

The Korean editorial leadership of the issue is itself noteworthy. Sung-Joo Hwang, Min-Soo Kim, and Heejun Park bring backgrounds spanning pharmaceutics, formulation technology, and drug delivery research, and their institutions sit within one of the world’s most dynamic pharmaceutical manufacturing regions. South Korea’s pharmaceutical sector has invested heavily in contract development and manufacturing, biosimilars, and advanced formulation capabilities, making it a natural vantage point for an issue centered on translation. The Journal of Pharmaceutical Investigation, published by Springer, has long served as a venue for Asian pharmaceutical science with an international readership, and a special issue of this scope is likely to draw submissions from academia, generic and innovative drug companies, and contract research organizations alike.

For researchers, the practical details are straightforward: manuscripts are due by June 30, 2026, for a January 2027 issue, and the editors welcome work across the six thematic areas from particle engineering for bioavailability through to QbD and PAT applications. For the broader field, the issue arrives at a moment when the pharmaceutical industry faces converging pressures. Pipelines increasingly dominated by poorly soluble molecules, biologics that demand entirely new delivery vehicles, regulatory expectations for continuous and data-rich manufacturing, and supply chains that must be both resilient and agile all converge on the same technical territory. Particle engineering and formulation science, once viewed as downstream services to discovery chemistry, now sit at the center of whether a molecule becomes a medicine. The special issue’s bet, implicit in its title, is that the most important advances of the coming years will be judged not by their novelty in isolation but by their ability to make that journey from particle to patient, reproducibly and at scale.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for drug 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, amorphous solid dispersions, pharmaceutical manufacturing, dosage forms, Journal of Pharmaceutical Investigation