Particle Engineering Takes Center Stage as Journal Opens Call for Translational Formulation Science

The Journal of Pharmaceutical Investigation has announced a special issue devoted to translational advances in pharmaceutical dosage form development, with a focus on the twin disciplines of particle engineering and formulation science. The issue, tentatively scheduled for publication in January 2027, is being assembled by a trio of guest editors from South Korean institutions: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Researchers have until June 30, 2026, to submit their work, and the scope of the call reads like a map of where drug delivery science is heading over the next decade.

At first glance, a call for papers might seem like an administrative event, but in pharmaceutical science these themed collections often signal where the field believes its bottlenecks lie. The topics listed by the editors span the entire journey of a medicine, from the first manipulation of a molecule’s solid form to the validated, regulated manufacturing line that produces billions of tablets or inhaler canisters. That journey is where many promising drug candidates historically have stalled, and it is precisely the territory this special issue aims to cover.

The first listed topic, particle engineering approaches for solubility, stability, and bioavailability enhancement, addresses one of the most persistent problems in modern pharmacology. A large proportion of newly discovered drug molecules are poorly soluble in water, which means they dissolve slowly or incompletely in the gastrointestinal tract and never reach the bloodstream at therapeutic levels. Particle engineering attacks this problem by changing the physical characteristics of the drug particles themselves, reducing them to micron or nanometer dimensions to dramatically increase the surface area available for dissolution, or converting them into amorphous forms that carry higher free energy and therefore dissolve more readily than their stable crystalline counterparts.

These interventions come with trade-offs that make the field technically demanding. Nanocrystals stabilized by surfactants or polymers can aggregate during storage, undoing the dissolution advantage they were designed to provide. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer carrier, risk reverting to the crystalline state over time, a process known as recrystallization that can silently destroy bioavailability. The special issue’s emphasis on stability alongside solubility reflects this reality: a formulation that works on the day it is made but fails on the shelf is not a medicine. Researchers in this area increasingly combine experimental screening with computational prediction of molecular interactions to select carriers and processing conditions that lock in the desired physical state for the product’s entire lifetime.

The second topic broadens the view to advanced formulation strategies across every major route of administration, including oral, injectable, inhalable, and transdermal dosage forms, as well as advanced drug delivery systems. Each route imposes its own engineering constraints. Oral products must survive stomach acid and enzymatic attack before releasing their payload in the intestine. Injectable formulations must be sterile, isotonic, and free of particles that could trigger immune reactions. Inhaled medicines demand particles engineered to an aerodynamic diameter typically in the range of one to five micrometers so they can navigate the branching airways and deposit deep in the lungs rather than being exhaled or trapped in the throat. Transdermal systems must push molecules through the skin’s stratum corneum, a barrier that admits very few drugs without chemical enhancers, iontophoresis, or microneedle arrays.

The inclusion of advanced drug delivery systems in the scope signals interest in platforms that go beyond conventional pills and syringes: long-acting injectable depots that release drug over weeks or months, lipid nanoparticles that carry messenger RNA into cells, and targeted carriers designed to accumulate in diseased tissue. The lipid nanoparticle field in particular demonstrated its translational maturity during the COVID-19 pandemic, when the same core technology that had been refined for decades in nucleic acid delivery underpinned the first authorized mRNA vaccines. Formulation science, once viewed as a downstream service to drug discovery, has become a discipline capable of enabling entirely new therapeutic modalities.

Solid-state characterization and control, the third topic, is the analytical backbone supporting everything else. A single drug substance can exist in multiple crystalline forms, called polymorphs, each with different solubility, melting point, mechanical behavior, and stability. The classic cautionary tale is ritonavir, an HIV drug that in the late 1990s began crystallizing in a previously unknown, far less soluble polymorph during manufacturing, forcing a market withdrawal while the problem was solved. Modern development therefore relies on a battery of techniques, including X-ray powder diffraction to identify crystal structures, differential scanning calorimetry to map thermal transitions, dynamic vapor sorption to probe hygroscopicity, and spectroscopic methods such as Raman and near-infrared analysis to track molecular-level changes. Controlling the solid state means controlling which form appears during crystallization, which form survives drying and milling, and which form remains stable through years of storage in humid warehouses and medicine cabinets.

The fourth and fifth topics, translational formulation science with scale-up, and emerging manufacturing technologies, tackle the gap between what works in a laboratory beaker and what can be produced reliably at commercial scale. A formulation optimized in gram quantities may behave entirely differently when processed in hundreds of kilograms, because mixing efficiency, heat transfer, and residence time distributions all change with equipment size. Continuous manufacturing, in which product flows through connected unit operations rather than being made in discrete batches, has gained regulatory acceptance and offers tighter control, smaller facility footprints, and faster response to demand. Hot-melt extrusion, which continuously converts drug and polymer into amorphous solid dispersions by kneading them at elevated temperature, and spray drying, which rapidly fixes amorphous particles from a solution, are established examples of technologies that moved from niche to mainstream. Additive manufacturing, including 3D printing of tablets with tailored internal geometries that control release kinetics, represents the emerging frontier.

The final topic, applications of Quality by Design and Process Analytical Technology, describes the regulatory and quality philosophy that binds the whole enterprise together. Quality by Design, or QbD, asks developers to understand which formulation variables and process parameters critically affect product quality, and to design a design space within which those factors can vary while the product still meets its specifications. Process Analytical Technology, or PAT, supplies the real-time measurement tools, such as inline near-infrared spectroscopy and Raman probes, that make such control possible during production rather than through end-of-batch testing alone. Together they shift quality from being inspected into a product to being built into it, a change regulators have promoted for two decades and one that continuous manufacturing makes genuinely practical.

What makes this special issue notable is its explicitly translational framing. The phrase signals that the editors want work that bridges disciplines and moves toward patients, not isolated laboratory observations. For a journal based in Asia with an international authorship, the collection also highlights the region’s growing weight in pharmaceutical development, with guest editors drawn from three Korean universities active in drug delivery research. As poorly soluble molecules, biologics, and nucleic acid therapeutics continue to dominate development pipelines, the engineering of particles and formulations is likely to determine which laboratory discoveries ever become medicines. Submissions are open until June 30, 2026, and the resulting issue, due in January 2027, will offer a snapshot of a field working to make the next generation of drugs deliverable.

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, bioavailability, solid-state characterization, amorphous solid dispersions, Quality by Design, Process Analytical Technology, continuous manufacturing, pharmaceutical scale-up, polymorphism, Journal of Pharmaceutical Investigation