The central theme of the issue, translational formulation science, addresses one of the most persistent bottlenecks in modern drug development. A strikingly large share of new drug candidates emerging from discovery pipelines are poorly soluble in water, which limits how much of the compound the body can absorb and therefore how well the drug works. Particle engineering offers a family of strategies for overcoming this barrier by manipulating the physical form of the active ingredient itself: reducing particle size to the micrometer or nanometer scale, converting crystalline material into amorphous solid dispersions, or generating polymorphs and salts with more favorable dissolution behavior. Each of these approaches changes how the drug particles interact with the fluids of the gastrointestinal tract, the bloodstream, or the surfaces of the lung and skin.

Particle size reduction is among the oldest and most widely used tools in this arsenal. By milling or spraying a drug into finer particles, formulators dramatically increase the surface area available for dissolution, which accelerates the rate at which the compound dissolves and becomes available for absorption. Nanocrystal technology pushes this principle further, stabilizing drug nanoparticles with surfactants or polymers so that they remain suspended in liquid formulations or are incorporated into tablets and capsules. The technique has already enabled several marketed products for drugs that would otherwise have failed in development, and it remains a workhorse approach for rescuing difficult molecules.

Amorphous solid dispersions represent a complementary strategy. In these systems, the drug is dispersed at the molecular level within a polymer matrix, trapping it in a disordered, high-energy state that dissolves far more readily than its crystalline counterpart. The trade-off is physical instability: amorphous materials have a thermodynamic drive to recrystallize, which would erase the solubility advantage. Understanding and controlling this recrystallization risk is a core concern of solid-state characterization, another topic highlighted in the special issue. Techniques such as powder X-ray diffraction, differential scanning calorimetry, and dynamic vapor sorption allow scientists to fingerprint the solid form of a drug and monitor whether it remains stable through processing, storage, and the stresses of the digestive tract.

The scope of the issue extends well beyond oral dosage forms. The editors explicitly welcome work on injectable, inhalable, and transdermal delivery systems, each of which places distinct demands on particle and formulation design. Inhaled medicines, for example, require particles engineered to a precise aerodynamic size range, typically a few micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable formulations must balance particle characteristics with sterility, syringeability, and the risk of immune reactions, while transdermal systems depend on formulation chemistry that can drive molecules across the skin barrier. Advanced drug delivery systems, including long-acting injectables and targeted carriers, add further layers of complexity that particle engineering must address.

A distinctive emphasis of the special issue is scale-up, the step where many promising laboratory formulations stumble. A process that works flawlessly when producing a few hundred grams of material may behave very differently at the multi-kilogram scale needed for clinical trials and commercial supply. Mixing efficiency, drying rates, heat transfer, and mechanical stresses all change with equipment size and geometry, and subtle shifts in these variables can alter the solid form or particle size distribution of the product. Translational formulation science aims to anticipate these changes, building robustness into formulations so that the product a patient ultimately receives matches the one validated in early development.

Emerging manufacturing technologies are expected to feature prominently in the accepted papers. Continuous manufacturing, in which raw materials flow through an integrated production line rather than moving between batch operations, offers tighter process control and smaller equipment footprints. Additive manufacturing, including various pharmaceutical 3D printing approaches, allows dosage forms with customized geometries and drug release profiles that would be impossible with conventional tableting. Hot-melt extrusion, spray drying, and supercritical fluid technologies likewise give formulators new ways to generate engineered particles at scale. The special issue invites reports on how these technologies perform in real production environments, not just in the laboratory.

Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, provide the regulatory and analytical framework that ties much of this work together. Under QbD, developers systematically identify the critical quality attributes of a product and the process parameters that control them, building a scientific understanding that supports flexibility in manufacturing rather than rigid, trial-and-error validation. PAT complements this philosophy by embedding real-time sensors, such as near-infrared spectroscopy and Raman spectroscopy, directly into production equipment, allowing operators to monitor particle size, composition, and solid form as the process runs. Together, these approaches enable continuous verification of quality and faster troubleshooting, and regulators in the United States, Europe, and Asia have increasingly encouraged their adoption.

The guest editors bring substantial expertise across these domains. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery systems, Min-Soo Kim of Pusan National University works extensively on particle engineering and solubility enhancement, and Heejun Park of Duksung Women’s University contributes expertise in formulation development and physical pharmacy. Their combined perspective signals that the issue will weigh both the scientific depth of particle-level research and its practical readiness for industrial application, a balance that defines translational science.

For researchers working at the intersection of materials science, pharmaceutical technology, and manufacturing engineering, the call for papers represents an opportunity to publish work aimed squarely at the gap between discovery and delivery. Submissions are due by June 30, 2026, ahead of the January 2027 publication date. As drug molecules grow more complex and more insoluble, the ability to engineer particles and formulations that survive manufacturing, storage, and the human body has become as important as the molecules themselves. This special issue aims to gather the advances that are making that engineering reliable, reproducible, and ready for patients.

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

DOI: Not provided

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