Particle Engineering Takes Center Stage as Pharmaceutical Formulation Science Moves 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 science, focusing on how particle engineering and formulation design are transforming laboratory discoveries into medicines that actually reach patients. Scheduled for publication in January 2027 and led by three guest editors from South Korean universities, the issue is soliciting contributions across the full spectrum of dosage form development, from molecular-level solid-state control to industrial-scale manufacturing. The submission deadline is June 30, 2026, and the scope signals where the pharmaceutical sciences community believes the next generation of translational breakthroughs will come from.

The guest editorial team combines deep expertise across academia and pharmaceutical technology. Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University are coordinating the issue, bringing together perspectives on drug delivery systems that span oral tablets, injectable suspensions, inhaled powders, and transdermal patches. Their shared premise is that the bottleneck in modern pharmacotherapy is often not the discovery of a biologically active molecule but the physical and chemical engineering required to deliver that molecule to the right place in the body at the right concentration.

That premise reflects a well-documented crisis in drug development. A large fraction of candidate molecules identified by high-throughput screening are poorly soluble in water, which means they dissolve too slowly or incompletely in the gastrointestinal tract to achieve therapeutic blood levels. Particle engineering attacks this problem directly by manipulating crystal size, shape, and surface properties. Reducing an active pharmaceutical ingredient to micrometer or nanometer dimensions dramatically increases its surface-area-to-volume ratio, accelerating dissolution according to the Noyes-Whitney relationship that governs how solids dissolve into surrounding fluids. Nanocrystal suspensions, for example, have enabled the formulation of dozens of marketed drugs that would otherwise have failed in development.

But shrinking particles is only one tool in an expanding arsenal. The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, a framing that encompasses amorphous solid dispersions, cocrystals, polymorph selection, and surface modification. Amorphous materials lack the ordered crystal lattice of their crystalline counterparts, giving them higher free energy and therefore greater apparent solubility, but that same instability makes them prone to reverting to crystalline forms during storage. Stabilizing amorphous dispersions with polymeric carriers requires a sophisticated understanding of molecular interactions, glass transition temperatures, and moisture uptake, all of which fall squarely within the formulation science the issue aims to showcase.

Solid-state characterization and control form another pillar of the call for papers. The physical form of a drug substance is not a fixed property but a variable that can shift during milling, wet granulation, drying, or even simple storage under humid conditions. A transition from one polymorph to another can alter dissolution rate, mechanical properties, and chemical stability, with regulatory and clinical consequences. Modern analytical techniques such as powder X-ray diffraction, solid-state nuclear magnetic resonance spectroscopy, differential scanning calorimetry, and Raman microscopy allow scientists to detect and quantify these transformations with remarkable sensitivity. The challenge, and a central theme of translational formulation science, is converting that analytical insight into control strategies that hold throughout a product’s lifecycle.

The issue’s emphasis on translational formulation science and scale-up acknowledges a persistent gap between what works in a laboratory beaker and what can be manufactured reproducibly at industrial scale. A nanocrystal suspension prepared in milliliter batches using laboratory homogenizers may behave very differently when produced in thousands of liters, where mixing dynamics, heat transfer, and shear forces change fundamentally. Similarly, hot-melt extrusion, spray drying, and supercritical fluid processing each have scale-dependent parameters that can alter the final product’s critical quality attributes. Contributions addressing how formulation scientists bridge this lab-to-plant divide are expected to be a highlight of the collection.

Emerging manufacturing technologies represent perhaps the most forward-looking topic in the issue’s scope. Continuous manufacturing, in which raw materials flow through an integrated production line rather than moving between discrete batch steps, is reshaping how pharmaceutical companies think about quality and flexibility. Additive manufacturing, commonly known as three-dimensional printing, opens the possibility of dosage forms with complex internal geometries tailored to release a drug at specific rates, or even of decentralized production in hospitals and pharmacies. These technologies demand new process analytical tools and new regulatory frameworks, and their maturation from pilot demonstrations to commercial production is exactly the kind of translational story the guest editors want to document.

Quality by Design, often abbreviated as QbD, and Process Analytical Technology, or PAT, provide the methodological backbone for much of this work. QbD is a regulatory philosophy, formalized in guidance from agencies including the United States Food and Drug Administration, that requires developers to understand how formulation and process variables affect product quality, rather than simply testing finished products and hoping for the best. PAT supplies the real-time measurement tools, such as near-infrared spectroscopy probes embedded in production equipment, that make such understanding actionable. Together they shift pharmaceutical development from an empirical, trial-and-error enterprise toward a predictive science built on design of experiments, mechanistic modeling, and multivariate data analysis. The special issue’s inclusion of QbD and PAT applications signals that methodological rigor is as welcome as novel formulations.

The breadth of dosage forms covered, spanning oral, injectable, inhalable, and transdermal delivery alongside advanced drug delivery systems, underscores how particle and formulation science cuts across therapeutic areas and routes of administration. Inhaled medicines depend on particle aerodynamic diameter, typically one to five micrometers, to deposit in the deep lung rather than the throat. Injectable long-acting suspensions rely on controlled particle size distributions to govern how slowly a drug dissolves and releases over weeks or months. Transdermal systems must balance drug solubility in adhesive matrices with permeability through the skin’s outermost barrier. Each route imposes distinct physical constraints, yet the underlying scientific principles of nucleation, crystallization, wetting, and diffusion are shared, which is precisely why a unified special issue rather than fragmented silos makes scientific sense.

For researchers, the January 2027 issue offers a venue for work that connects molecular physics to patient outcomes, and the June 30, 2026 deadline gives laboratories a clear target. For the broader pharmaceutical community, the collection promises a snapshot of a discipline in transition, one in which computational prediction, advanced analytics, and novel manufacturing converge to shorten the path from molecule to medicine. As drug pipelines increasingly fill with difficult-to-formulate molecules, including poorly soluble small compounds and complex biologics, the engineering of particles and dosage forms is no longer a downstream afterthought. It is, as this special issue’s very title asserts, the frontier where translational advances in pharmacotherapy will increasingly be won.

Subject of Research: Translational pharmaceutical dosage form development using 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

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Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, nanocrystals, amorphous solid dispersions, continuous manufacturing, scale-up, Journal of Pharmaceutical Investigation