Particle Engineering Takes Center Stage in Push to Translate Drug Formulation Science

A major pharmaceutical science journal is preparing to devote an entire special issue to one of the most consequential questions in modern drug development: how to move laboratory-scale breakthroughs in particle engineering and formulation science into dosage forms that can actually be manufactured, regulated, and delivered to patients. The Journal of Pharmaceutical Investigation, published by Springer, has announced a special issue titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, scheduled for publication in January 2027. The submission deadline for contributors is June 30, 2026, giving research groups worldwide a defined window to submit work that spans the full journey from powder properties to finished drug product.

The issue is being assembled by three 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. All three are established figures in pharmaceutics and drug delivery research, and their combined editorial oversight signals that the issue will emphasize rigor at the interface between fundamental formulation science and practical, translational outcomes. The Journal of Pharmaceutical Investigation has long served as a venue for research on drug formulation, delivery systems, and the pharmaceutical technologies that underpin them, and a themed collection of this kind is intended to gather the state of the art in a single, coherent place for researchers, formulators, and regulatory scientists alike.

The scope of the call covers six broad thematic areas, and together they map almost perfectly onto the technical bottlenecks that determine whether a promising molecule ever becomes a medicine. The first is particle engineering approaches for enhancing solubility, stability, and bioavailability. This is arguably the central challenge of contemporary formulation science: a large fraction of newly discovered drug candidates, particularly small molecules emerging from high-throughput screening campaigns, are poorly soluble in water. Poor solubility limits how much of a drug can dissolve in the gastrointestinal tract, which in turn limits how much reaches the bloodstream. Particle engineering attacks this problem at its physical root by manipulating crystal size, shape, and habit, or by bypassing the crystalline state altogether.

The technical toolbox here is rich and rapidly evolving. Micronization and nanonization reduce particle size to increase surface area and accelerate dissolution, following the well-established Noyes-Whitney relationship between surface area and dissolution rate. Nanocrystal stabilization, typically with surfactants or polymeric stabilizers, prevents the fine particles from simply aggregating back into larger, slower-dissolving clumps. Beyond size reduction, scientists engineer solid-state forms themselves: polymorph selection, where the same molecule packs into different crystal lattices with different solubilities and stabilities, and cocrystal formation, where the active drug is co-crystallized with a benign partner molecule to tune its properties. Amorphous solid dispersions take a different route, locking the drug in a disordered, higher-energy glassy state within a polymer matrix, trading thermodynamic stability for dramatically improved apparent solubility. Each of these strategies carries its own manufacturing and stability trade-offs, which is precisely why the special issue pairs particle engineering with formulation science rather than treating them separately.

The second thematic area addresses advanced formulation strategies for pharmaceutical dosage forms, explicitly spanning oral, injectable, inhalable, and transdermal routes, along with broader advanced drug delivery systems. Each route imposes distinct demands on the formulation scientist. Oral solid dosage forms, still the dominant class of medicines worldwide, must survive manufacturing stresses, remain chemically and physically stable over shelf life, and release their payload predictably in the body. Injectable formulations face the harshest constraints of all: they must be sterile, free of visible and subvisible particulates, isotonic or otherwise physiologically compatible, and stable in solution or suspension, often at high concentrations for biologics where aggregation poses immunogenicity risks. Inhaled products require particle sizes in a narrow aerodynamic range, typically one to five micrometers, to deposit in the lungs rather than the throat or the deep alveoli, and they depend on intricate interplay between the drug particles, the propellant or carrier lactose, and the device. Transdermal systems must drive molecules across the skin’s formidable barrier, relying on drug properties, adhesive chemistry, and in some cases enhancement technologies. A single special issue touching all of these routes reflects how particle and formulation science has become a unifying discipline across delivery modalities.

The third area, solid-state characterization and control, is the analytical backbone that makes the rest of the field trustworthy. Because a drug substance can exist in multiple solid forms with different performance characteristics, developers must know exactly which form they have, whether it will convert to another form during processing or storage, and how to detect such changes before they affect patients. Techniques such as powder X-ray diffraction, differential scanning calorimetry, thermogravimetric analysis, dynamic vapor sorption, and various forms of spectroscopy allow scientists to fingerprint solid phases and quantify mixtures. Control matters as much as characterization: drying, milling, wet granulation, and even compression can induce phase transformations, so understanding the process-induced behavior of solids is essential to ensuring that the product a patient swallows matches the product that was tested in the clinic. Work in this area often determines whether a formulation is robust enough to survive global supply chains and varying humidity and temperature conditions.

The fourth theme, translational formulation science and scale-up of drug products, gets to the heart of the special issue’s title. A formulation that performs beautifully in a one-kilogram laboratory batch can fail spectacularly when produced at commercial scale in hundreds of kilograms. Mixing efficiency, heat transfer, drying kinetics, and equipment geometry all change with scale, and subtle differences in particle size distribution or blend uniformity can shift dissolution behavior and bioavailability. Translational formulation science seeks to anticipate these shifts early, using small-scale models that predict large-scale behavior, and to design formulations that are inherently manufacturable rather than merely functional. This is where academic discovery meets industrial reality, and contributions that demonstrate successful translation from bench to pilot to commercial production are likely to be among the issue’s most valuable offerings.

The fifth area focuses on emerging manufacturing technologies in dosage form design and commercial production. Continuous manufacturing has moved from concept to implementation across the industry, replacing batch processes with integrated production lines that flow from powder feeding through blending, granulation, tableting, and coating without stopping. Additive manufacturing, including various 3D printing approaches, enables dosage forms with complex internal geometries and, in principle, personalized doses tailored to individual patients. Hot-melt extrusion, spray drying, and electrospinning offer routes to amorphous and nanostructured materials at production scale. These technologies do not merely speed things up; they change what kinds of dosage forms are possible, allowing controlled release profiles and combination products that would be difficult or impossible with conventional batch equipment.

The sixth theme ties everything together through Quality by Design and Process Analytical Technology, often abbreviated as QbD and PAT. Quality by Design is a regulatory philosophy, championed by agencies including the FDA and embraced in ICH guidelines, that asks developers to build quality into a product by design rather than testing it in afterward. It requires identifying critical quality attributes, understanding which process parameters and material properties drive those attributes, and establishing a design space within which the product reliably meets specifications. Process Analytical Technology supplies the real-time eyes: inline and online sensors such as near-infrared spectroscopy and Raman spectroscopy that monitor blend uniformity, granulation endpoints, and drying progress as they happen, enabling feedback control rather than end-of-batch inspection. Together, QbD and PAT transform formulation development from an empirical craft into a science-based engineering discipline, and they are now effectively prerequisites for modern regulatory filings.

For researchers considering submission, the June 30, 2026 deadline and the January 2027 publication date frame a clear timeline, and the breadth of the six themes means the issue could encompass everything from fundamental studies of nucleation and crystal growth to case studies of commercial process development. What unites the call is a translational orientation: the guest editors are explicitly seeking work that advances dosage form development, not just molecular or theoretical insight in isolation. In an era when an increasing share of pipeline molecules are poorly soluble, biologic, or targeted at delivery routes far more demanding than a simple tablet, the ability to engineer particles and formulations with precision has become a decisive competitive and scientific advantage. A dedicated collection on this subject, arriving as continuous manufacturing and real-time analytics reshape how medicines are made, is positioned to serve as both a snapshot of the field and a roadmap for where pharmaceutical formulation science goes next.

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