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

The pharmaceutical sciences community is preparing for a major gathering of ideas around one of the most consequential questions in modern drug development: how do laboratory-scale breakthroughs in particle engineering and formulation science become medicines that patients can actually take? The Journal of Pharmaceutical Investigation has announced a special issue, scheduled for publication in January 2027, devoted to translational advances in pharmaceutical dosage form development based on particle engineering and formulation science. The issue, led by three guest editors based in South Korea, is now open for contributions, with a submission deadline of June 30, 2026. For researchers working at the intersection of materials science, process engineering, and clinical pharmacology, the announcement signals a moment to take stock of how far the field has moved from empirical trial-and-error formulation toward a rational, design-driven discipline.

The special issue will be helmed by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three institutions that anchor a substantial portion of South Korea’s pharmaceutical formulation research. Their combined editorial scope spans the full life cycle of a dosage form, from the first manipulation of a drug substance’s physical properties to the validated, regulated manufacturing processes that carry a product into commercial production. That breadth is deliberate. The central premise of the issue is that particle engineering and formulation science are no longer separate, sequential steps in drug development but tightly coupled disciplines whose integration determines whether a promising molecule ever reaches the market in a form that works.

At the heart of the call for papers is the problem that has defined formulation science for decades: solubility. An estimated large fraction of newly discovered drug candidates, particularly those emerging from high-throughput screening campaigns, are poorly soluble in water, which limits their absorption in the gastrointestinal tract and undermines their bioavailability. Particle engineering offers a family of approaches to this problem that operate at the level of the solid state itself. By reducing particle size to the micron or nanometer scale, formulators increase the surface area available for dissolution. By transforming a drug into a different solid form, such as an amorphous solid dispersion rather than a crystalline lattice, they can create a higher-energy state that dissolves more readily, though at the cost of a persistent challenge in maintaining that state over a product’s shelf life. The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, a phrasing that captures the delicate trade-off between making a drug dissolve faster and keeping it chemically and physically intact.

Stability is where much of the technical difficulty lives. An amorphous form of a poorly soluble drug may deliver a dramatic improvement in oral absorption, but amorphous materials have a thermodynamic drive to recrystallize, which can erase the solubility advantage and, in the worst case, alter the dissolution profile of a marketed product. Formulation scientists respond with stabilizing polymer matrices, careful selection of storage conditions, and increasingly sophisticated analytical methods to detect the earliest signs of phase change. Solid-state characterization and control appears as its own topic in the special issue, reflecting the reality that techniques such as X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance are now indispensable tools for understanding exactly what physical form a drug substance takes inside a finished dosage form, and how that form behaves under stress.

Beyond the solid oral tablet, the issue’s scope reaches across the full spectrum of delivery routes. Advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms, along with broader advanced drug delivery systems, are all named topics. Each route imposes its own particle-level demands. Inhaled medicines, for example, require particles engineered to a precise aerodynamic diameter, typically in the range of one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable formulations must balance particle size and rheology to pass through fine needles while remaining stable in suspension. Transdermal systems depend on drug release kinetics and matrix design that allow molecules to traverse the skin barrier at therapeutic rates. The common thread is that in every case, the physical properties of the drug particles and the architecture of the formulation determine the clinical performance of the product.

Perhaps the most distinctive emphasis of the special issue, and the one that gives it its translational character, is the explicit focus on scale-up. Translational formulation science and the scale-up of drug products is listed as a standalone topic, and it addresses a notorious gap in pharmaceutical development. A formulation that performs beautifully when mixed in a one-liter laboratory vessel may behave entirely differently when produced in a two-hundred-liter industrial mixer, where differences in heat transfer, mixing dynamics, drying rates, and residence time can change particle size distributions, residual solvent levels, and even the solid form of the drug itself. Bridging that gap requires not just engineering intuition but quantitative models that predict how a process will behave as dimensions change, and the field has been steadily building such models through computational fluid dynamics, population balance modeling, and mechanistic understanding of unit operations such as wet granulation, spray drying, and hot-melt extrusion.

Emerging manufacturing technologies form another pillar of the call. Continuous manufacturing, in which raw materials flow through an integrated train of operations without the batch-based stops and starts of traditional production, has moved from a research concept to a regulatory-endorsed reality for several approved products. Additive manufacturing, including various forms of pharmaceutical 3D printing, allows dosage forms with internally customized geometries that control release kinetics in ways conventional compression cannot achieve. These technologies are reshaping what dosage form designers can imagine, and the special issue invites contributions on emerging manufacturing technologies in dosage form design and commercial production, signaling that the editors want to see work that has one eye on the factory floor rather than the laboratory bench alone.

Woven through all of these topics is the regulatory and quality framework that governs modern pharmaceutical manufacturing. Quality by Design, commonly abbreviated as QbD, is the principle that product and process quality should be designed into a formulation from the outset, through systematic identification of the material attributes and process parameters that genuinely affect performance, rather than tested in at the end. Process Analytical Technology, or PAT, supplies the real-time measurement tools, such as near-infrared spectroscopy and Raman spectroscopy embedded directly in production lines, that make such a design approach operable. The special issue explicitly names QbD and PAT applications in pharmaceutical formulation and manufacturing as a topic, underscoring that the translational ambition of the issue extends to how products are controlled, documented, and approved, not merely how they are conceived.

The timing of the issue is significant for the broader industry. The pharmaceutical pipeline is increasingly dominated by molecules that present severe formulation challenges: poorly soluble small molecules, high-potency compounds that demand containment strategies, biologics that require careful protection of delicate three-dimensional structures, and combination products that must deliver more than one active ingredient with independent release profiles. At the same time, regulatory agencies around the world are encouraging continuous manufacturing and advanced analytics as ways to improve supply chain resilience and product quality. Formulation scientists who can demonstrate that their particle engineering strategies survive the journey from bench to validated commercial process are therefore in a position of unusual influence, and venues that publish such end-to-end work perform a valuable service for the field.

For prospective authors, the practical details are straightforward. Submissions are due by June 30, 2026, with the issue slated for January 2027, giving research groups roughly a year and a half to complete studies, generate data, and prepare manuscripts. The guest editors, representing Yonsei University, Pusan National University, and Duksung Women’s University, bring complementary expertise across drug delivery systems, formulation technology, and pharmaceutical manufacturing, and their editorial framing makes clear that the issue is intended as a comprehensive snapshot of where translational dosage form science stands. Whether the resulting collection becomes a reference point for the next generation of medicine design will depend on the community’s response, but the questions it poses, how to make insoluble drugs deliverable, how to keep engineered particles stable, and how to manufacture them reliably at scale, are the questions on which the future of pharmacotherapy increasingly turns.

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, solubility enhancement, bioavailability, solid-state characterization, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, dosage forms, pharmaceutical manufacturing