Particle Engineering Takes Center Stage as Pharmaceutical Formulation Science Heads Toward Translational Milestone

The pharmaceutical sciences community is preparing for a landmark collection of research that could reshape how medicines move from the laboratory bench to the pharmacy shelf. The Journal of Pharmaceutical Investigation, published by Springer, has announced a special issue devoted to translational advances in pharmaceutical dosage form development based on particle engineering and formulation science, scheduled for publication in January 2027. The issue will be guided by three guest editors from leading South Korean institutions: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. With a submission deadline of June 30, 2026, the editors are inviting researchers worldwide to contribute work that bridges a persistent gap in drug development: the distance between an elegant laboratory formulation and a manufacturable, clinically effective medicine.

The central premise of the special issue reflects one of the most consequential challenges in modern pharmacology. A striking proportion of newly discovered drug candidates, particularly small molecules emerging from high-throughput screening campaigns, suffer from poor aqueous solubility. A compound may show exquisite activity against its biological target in vitro, yet fail to reach therapeutic concentrations in the bloodstream because it simply cannot dissolve in gastrointestinal fluids or plasma. Particle engineering addresses this problem at its physical root, manipulating the size, shape, morphology, and solid-state form of drug particles to alter how they interact with solvents and biological membranes. Reducing particle dimensions into the micrometer or nanometer range dramatically increases the surface-area-to-volume ratio, accelerating dissolution rates and, in many cases, improving the extent of absorption.

The announced scope of the issue explicitly highlights particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that the editors expect submissions spanning the full toolkit of modern particle science. This includes well-established techniques such as micronization by jet milling and controlled crystallization, alongside newer strategies like nanosizing through wet media milling or high-pressure homogenization, spray-drying to produce amorphous solid dispersions, and supercritical fluid technologies that generate particles with precisely tailored characteristics. Each method carries distinct trade-offs between dissolution advantage and physical stability, since finely divided and amorphous materials often possess thermodynamic drive to revert to more stable, less soluble crystalline forms during storage. Managing that instability, through polymer stabilization, careful selection of solid-state form, and sophisticated packaging, remains a defining concern of the field.

Closely allied to particle engineering is the discipline of solid-state characterization and control, another named topic of the special issue. Pharmaceutical solids can exist in multiple crystalline polymorphs, each with a distinct arrangement of molecules in the crystal lattice and, consequently, distinct solubility, melting point, mechanical behavior, and stability profile. The most infamous cautionary tale is that of ritonavir, an antiretroviral drug whose late-emerging, more stable polymorph precipitated from marketed formulations in the late 1990s, forcing a withdrawal and reformulation that cost the manufacturer hundreds of millions of dollars. Modern development therefore treats polymorph screening, salt and co-crystal selection, and amorphous material characterization as foundational activities. Analytical techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint each solid form and monitor whether it persists unchanged through processing, storage, and administration.

The special issue also casts a deliberately wide net over dosage forms and delivery systems, encompassing oral, injectable, inhalable, and transdermal products, among others, together with advanced drug delivery systems. Each route imposes its own particle and formulation requirements. Oral solid dosage forms, still the dominant category by volume, depend on powder flow, compressibility, and disintegration behavior that are all sensitive to particle attributes. Injectable formulations, including the rapidly growing class of subcutaneous biologics, confront constraints of viscosity, syringeability, and particulate contamination that push formulation scientists toward high-concentration protein solutions and long-acting crystalline suspensions. Inhalable medicines demand particles within a tight aerodynamic diameter window, typically one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must balance drug permeability through the stratum corneum against the adhesive and rheological properties of the matrix. The editors’ inclusive framing suggests they anticipate cross-cutting insights that transfer across these boundaries.

Perhaps the most distinctive emphasis of the announcement is its insistence on translational formulation science and the scale-up of drug products. This theme addresses a well-recognized valley of death in pharmaceutical development: formulations that perform beautifully at the one-gram or one-liter laboratory scale frequently behave differently when produced in hundreds of kilograms. Mixing efficiency, drying kinetics, granulation behavior, and even the solid form itself can shift during scale-up, sometimes with therapeutic consequences. Translational science in this context means designing experiments and models that predict, rather than merely observe, how a formulation will respond to changes in equipment, batch size, and process parameters. Contributions that demonstrate successful technology transfer from research setting to commercial production, or that develop predictive frameworks for such transfers, would sit squarely within the issue’s ambitions.

Emerging manufacturing technologies form another pillar of the announced scope, reflecting an industry in the midst of a production paradigm shift. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations without batch-wise interruption, is steadily displacing traditional batch processing for solid oral doses, offering tighter control, smaller footprints, and faster response to demand. Additive manufacturing, commonly known as three-dimensional printing, has already produced the first approved printed medicine and opens possibilities for personalized dosing and complex release architectures that conventional compression cannot achieve. Hot-melt extrusion, electrospinning, microfluidic nanoparticle production, and advanced coating technologies likewise expand the design space available to formulators. The special issue’s call for work on emerging technologies in dosage form design and commercial production indicates that the editors want not only laboratory proofs of concept but also assessments of how these platforms perform under regulatory and economic scrutiny.

Underpinning all of these themes is the pairing of Quality by Design and Process Analytical Technology, both explicitly named in the issue’s topic list. Quality by Design, a regulatory philosophy codified in international guidance, requires developers to understand and control the relationships between formulation variables, process parameters, and product quality attributes, rather than relying on end-product testing alone. Process Analytical Technology supplies the instrumentation, near-infrared spectroscopy, Raman spectroscopy, laser diffraction, and inline sensors of various kinds, that makes real-time monitoring and control feasible on the factory floor. Together, these frameworks transform formulation development from an empirical craft into a quantitative engineering discipline. Researchers who can demonstrate how PAT tools detect polymorphic transformations during drying, or how design-of-experiments approaches de-risk a scale-up campaign, will be addressing questions that regulators and manufacturers alike regard as essential.

The timing and venue of the special issue carry their own significance. The Journal of Pharmaceutical Investigation, based in South Korea with an increasingly international authorship and readership, has positioned itself as a forum where Asian pharmaceutical science and global industry perspectives converge. South Korea hosts a robust ecosystem of generic and innovative drug manufacturers, contract development organizations, and academic centers, making it a natural vantage point for translational formulation research. A January 2027 publication date places the issue at a moment when the industry is simultaneously absorbing the implications of an expanding pipeline of poorly soluble small molecules, a surging population of biologic drugs requiring novel delivery devices, and mounting pressure to manufacture medicines more flexibly and sustainably. The convergence of these pressures makes particle engineering and formulation science not peripheral technical specialties but central determinants of which drug candidates ultimately reach patients.

For researchers considering submission before the June 30, 2026 deadline, the announcement effectively sketches a map of where the field believes its most valuable contributions lie. Work that connects a particle-level intervention, a new crystallization route, a stabilized nanosuspension, a rationally selected co-crystal, to a demonstrable clinical or commercial outcome will define the translational spirit the guest editors have invoked. Equally, studies that quantify how advanced analytics and design principles reduce development timelines or improve product robustness speak directly to the industry’s economic and regulatory realities. As the deadline approaches, the special issue stands as both a snapshot and a forecast: a snapshot of a discipline whose techniques have matured into indispensable tools of drug development, and a forecast that the next generation of medicines will be shaped as much by the engineering of particles and the science of formulations as by the discovery of the molecules they deliver.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for 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, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, pharmaceutical dosage forms, Journal of Pharmaceutical Investigation