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

A major scholarly effort to accelerate the translation of laboratory-scale particle and formulation innovations into real-world medicines is taking shape in South Korea. The Journal of Pharmaceutical Investigation, a peer-reviewed journal published by Springer, has announced a special issue devoted to 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, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three researchers whose work spans the interface between pharmaceutical materials science, manufacturing technology, and drug product development. Submissions are open until June 30, 2026, giving research groups worldwide a defined window to contribute studies that bridge the persistent gap between an elegant bench-top formulation and a manufacturable, regulator-ready medicine.

The framing of the special issue reflects a quiet but consequential shift in how the pharmaceutical industry thinks about dosage forms. For decades, the formulation scientist’s job was often described as making a molecule fit into a capsule or a vial. Today, the discipline is far more ambitious: it treats the physical state of a drug, the architecture of its particles, and the design of its manufacturing process as a single, integrated engineering problem. That integration matters because an increasing share of the drug pipeline consists of molecules that are poorly soluble, physically unstable, or otherwise difficult to deliver. Estimates across the industry consistently suggest that a large fraction of new active pharmaceutical ingredients, particularly those emerging from high-throughput screening, fall into the poorly water-soluble category, which can undermine oral absorption and force developers toward costly alternative delivery routes.

Particle engineering sits at the heart of the response to that challenge. The term covers a family of techniques designed to control not just how big a drug particle is, but how it is shaped, structured, and composed. Micronization by jet milling, long a workhorse of inhalation and oral formulation, reduces particle size to increase surface area and thereby accelerate dissolution. More advanced approaches go further. Spray drying can convert a crystalline, poorly soluble drug into an amorphous solid dispersion, in which the molecule is locked in a glassy matrix with a polymer that prevents it from reverting to its stubborn crystalline form. Hot-melt extrusion achieves a similar outcome through heat and shear, while techniques such as antisolvent crystallization, supercritical fluid processing, and nano-milling allow formulators to tune crystal habit, polymorphic form, and particle size distribution with remarkable precision. Each of these interventions changes how the drug dissolves in the gastrointestinal tract, how it behaves in the bloodstream, and how long it remains stable on a shelf.

The special issue’s topic list makes clear that solubility and bioavailability enhancement is only one pillar. A second focus is advanced formulation strategies across the full spectrum of delivery routes: oral, injectable, inhalable, transdermal, and beyond. Each route imposes its own engineering constraints. Inhaled medicines, for example, demand particles in a narrow aerodynamic size range, typically around one to five micrometers, so that they deposit in the deep lung rather than in the throat or exhaled air. Injectable formulations must balance drug concentration against osmolality, pH, and viscosity, and increasingly rely on long-acting depots, liposomes, and polymer-based nanoparticles that release their payload over weeks or months. Transdermal systems must coax large or lipophilic molecules through the skin’s outer barrier, often with the help of chemical permeation enhancers, microneedle arrays, or iontophoretic driving forces. The journal’s call for papers explicitly invites work on advanced drug delivery systems, signaling interest in platform technologies that can carry a molecule to the right place at the right rate.

A third pillar, and one that has grown enormously in importance, is solid-state characterization and control. The physical form of a drug, whether crystalline polymorph, amorphous glass, hydrate, salt, or cocrystal, governs its dissolution rate, its tendency to convert to a more stable but less useful form, and ultimately its regulatory acceptability. The industry learned this lesson painfully through incidents in which a marketed product switched polymorph during manufacturing or storage, with serious consequences for drug release. Modern characterization therefore combines X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, spectroscopic methods such as Raman and solid-state nuclear magnetic resonance, and increasingly computational tools that predict which crystal forms a molecule can adopt. The special issue’s emphasis on control, not merely characterization, points toward strategies for keeping a chosen solid form stable through processing, packaging, and years of storage.

Perhaps the most consequential theme in the announcement is translational formulation science and scale-up. It is one thing to prepare a few milligrams of a nanosuspension in a laboratory beaker; it is another to produce hundreds of kilograms of it, batch after batch, with particle size distributions that fall within tight specifications. Scale-up is where many promising formulations fail. Mixing efficiency, heat transfer, and shear forces do not scale linearly, and a process that worked flawlessly at one liter can behave entirely differently at one thousand. Translational formulation science addresses this by designing processes with manufacturability in mind from the outset: choosing unit operations that are inherently scalable, building mathematical models of how critical process parameters affect critical quality attributes, and verifying those models at intermediate scales before committing to commercial equipment. Continuous manufacturing, in which powder and liquid streams flow through connected equipment rather than sitting in discrete batches, is one of the most visible expressions of this philosophy and has gained regulatory encouragement for its potential to improve consistency and enable flexible, smaller-footprint production.

The topics of Quality by Design and Process Analytical Technology, both named explicitly in the call, provide the regulatory and analytical scaffolding for that philosophy. Quality by Design, or QbD, inverts the traditional approach to pharmaceutical development. Instead of testing finished products to catch defects, developers first define the quality target that matters for the patient, identify which material attributes and process parameters genuinely affect that target, and then build a design space within which the product is guaranteed to meet specifications. Process Analytical Technology, or PAT, supplies the real-time eyes and ears: inline and at-line sensors, often spectroscopic, that monitor blend uniformity, granulation endpoints, drying progress, or coating thickness as the process runs. Together, QbD and PAT allow manufacturers to understand and adjust their processes in real time rather than discovering problems weeks later in a quality-control laboratory. They also underpin regulatory pathways such as real-time release testing, in which product quality is assured by process data rather than by end-product testing alone.

Emerging manufacturing technologies form another named theme, and the field is unusually active. Additive manufacturing, including fused deposition modeling and semisolid extrusion printing, is being explored for personalized doses and complex release profiles that conventional tableting cannot achieve. Microfluidic and nano-precipitation platforms offer exquisite control over lipid nanoparticle formation, a technology whose public profile rose sharply with mRNA vaccines but whose applications extend to oncology, gene silencing, and long-acting injectables. Electrospinning produces nanofiber mats for wound dressings and fast-dissolving oral films. Supercritical antisolvent processes and controlled crystallization systems are being engineered for consistent, solvent-free production of engineered crystals. Each of these technologies faces the same translational test: can it run under good manufacturing practice conditions, at commercial scale, with validated cleaning, robust process control, and acceptable cost?

For readers outside the field, it is worth underlining why this kind of work deserves attention. The dose form is not a cosmetic afterthought; it is often the difference between a molecule that works and one that fails. A poorly soluble compound that dissolves too slowly may never reach therapeutic blood levels, and a decade of discovery chemistry can be wasted. Conversely, a cleverly engineered particle can rescue a shelved candidate, extend the patent life of an established medicine, reduce pill burden, or turn a daily injection into a twice-yearly shot. Formulation science also shapes access: simpler, more stable dosage forms survive cold chains poorly served regions, and lower-cost continuous processes can bring down the price of essential medicines. The translational framing of the special issue acknowledges that the value of a pharmaceutical technology is realized only when it reaches patients.

The guest editors’ institutions hint at the collaborative breadth the issue hopes to capture. Yonsei University, Pusan National University, and Duksung Women’s University are all active centers of pharmaceutics research in South Korea, a country with a rapidly growing biopharmaceutical sector and strong government investment in advanced manufacturing. But the call is international, and the topics cut across academia, generic and innovator industry, and regulatory science. Researchers working on particle engineering for solubility and stability, novel dosage forms and delivery systems, solid-state control, scale-up, emerging manufacturing technologies, and QbD and PAT applications have until June 30, 2026, to submit their work for consideration in the January 2027 issue. If the field’s trajectory holds, the resulting collection will read less like a catalog of laboratory curiosities and more like a progress report on the industrialization of molecular design, the point at which particles, processes, and regulatory science converge into medicines that patients can actually take.

Subject of Research: Translational pharmaceutical formulation and particle engineering for 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, solubility enhancement, solid-state characterization, Quality by Design, Process Analytical Technology, scale-up, continuous manufacturing, amorphous solid dispersions, bioavailability, Journal of Pharmaceutical Investigation