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

A major pharmaceutical science journal is preparing to devote an entire special issue to one of the most consequential yet underappreciated corners of drug development: the engineering of particles and the formulation science that turns promising molecules into medicines patients can actually take. The Journal of Pharmaceutical Investigation 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 with a submission deadline of June 30, 2026. The issue will be guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three South Korean researchers working at the intersection of formulation design, manufacturing technology, and drug delivery.

The scope of the call for papers reads like a map of the modern pharmaceutical development pipeline. The editors are soliciting work on particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies spanning oral, injectable, inhalable, and transdermal dosage forms as well as advanced drug delivery systems; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies for dosage form design and commercial production; and applications of Quality by Design and Process Analytical Technology in formulation and manufacturing. Taken together, these topics describe the full journey of a drug substance from a crystalline powder in a laboratory vial to a reproducible, regulator-approved product made at industrial scale.

Why does particle engineering deserve an entire issue? The answer lies in a stubborn bottleneck that has shaped drug development for decades. A large share of new chemical entities emerging from discovery pipelines fall into the poorly soluble category, meaning they dissolve so slowly or incompletely in the gastrointestinal tract that patients cannot absorb therapeutic doses. A molecule can be extraordinarily potent against its biological target and still fail in the clinic simply because it never reaches the bloodstream in sufficient quantity. Particle engineering attacks this problem at its physical roots: by reducing particle size to the micrometer or nanometer scale, formulators dramatically increase the surface area available for dissolution; by converting a crystalline drug to a amorphous solid dispersion, they sidestep the energetic stability of the crystal lattice that makes dissolution slow in the first place.

The techniques involved are more varied than the phrase particle size reduction might suggest. Milling and jet milling remain workhorses for producing micronized powders, particularly for inhalation products where particle size distribution determines whether a drug deposits in the deep lung or is exhaled again. Supercritical fluid processing, spray drying, and anti-solvent crystallization offer finer control over particle morphology and polymorphic form. Nanocrystal technologies, in which drug particles are stabilized by surfactants or polymers at sizes measured in hundreds of nanometers, have already carried several commercial products to market. Each approach imposes its own trade-offs: amorphous forms dissolve faster but risk reverting to more stable, less soluble crystals during storage; nanoparticles offer high surface area but introduce challenges in filtration, sterilization, and long-term physical stability. The special issue’s emphasis on stability alongside solubility reflects exactly this balancing act.

Solid-state science forms a second pillar of the announced scope. The same molecule can crystallize in multiple polymorphic forms, each with distinct melting points, dissolution rates, and mechanical properties, and regulators require manufacturers to identify and control which form ends up in the product. The most infamous cautionary tale remains ritonavir, an HIV drug that spontaneously began crystallizing in a previously unknown, far less soluble polymorph years after launch, forcing a market withdrawal and a costly reformulation. Modern development therefore leans heavily on techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance to characterize and monitor the solid form of a drug throughout its shelf life. The special issue’s call for work on solid-state characterization and control signals that form selection and form stability remain live research frontiers rather than solved problems.

The word translational in the issue title carries particular weight. Academic formulation research has historically excelled at demonstrating elegant effects at bench scale, only to see those effects evaporate when processes are transferred to pilot plants and commercial manufacturing lines. Scale-up changes everything: mixing dynamics, drying rates, heat transfer, and even the way particles collide and agglomerate shift as equipment grows from grams to hundreds of kilograms. A spray-drying parameter optimized in a laboratory unit may produce a different particle morphology in a production dryer; a wet granulation that behaved predictably in a small bowl may segregate or over-granulate at scale. Translational formulation science, as the editors frame it, is about designing dosage forms and processes with this trajectory in mind from the outset, so that a formulation validated in the laboratory survives the journey through clinical trial supplies to commercial production without losing the performance that made it attractive.

Two regulatory and technological frameworks dominate that translation: Quality by Design and Process Analytical Technology. Quality by Design, embedded in international pharmaceutical development guidelines, asks manufacturers to build scientific understanding into the process itself, identifying the critical quality attributes of a product and the critical process parameters that control them, then designing a design space within which the process can operate flexibly while still guaranteeing quality. Process Analytical Technology supplies the real-time eyes for that approach: near-infrared spectroscopy, Raman spectroscopy, and other inline or atline sensors that monitor blend uniformity, granule moisture, tablet hardness, or crystal form as manufacturing proceeds, rather than relying solely on end-product testing of finished batches. Together they promise a shift from testing quality into a product to designing and monitoring quality into the process, and the special issue explicitly invites contributions on both.

The breadth of dosage forms covered in the call reflects how diversified drug delivery has become. Oral solid dosage forms, from immediate-release tablets to modified-release matrices, still dominate the market, but biologics and potent molecules have pushed injectable formulations, including long-acting depots and nanosuspensions, into greater prominence. Inhalable products demand exquisitely tight particle size control and device-formulation interplay. Transdermal systems bypass first-pass metabolism and improve adherence for drugs suited to skin permeation. Each route imposes distinct demands on particle properties, excipient selection, and manufacturing technology, and the editors’ decision to span all of them suggests they see particle engineering as a unifying discipline rather than a niche technique tied to any single delivery route.

Emerging manufacturing technologies round out the scope, and this is where the field’s near-term future is most visible. Additive manufacturing, notably three-dimensional printing of dosage forms, has already produced the first FDA-approved printed drug product and opens the door to personalized dosing and complex release architectures that conventional tableting cannot achieve. Continuous manufacturing, which replaces the traditional batch-and-queue model with a seamless flow from powder feed to finished tablet, shortens development timelines and shrinks facility footprints while pairing naturally with inline process analytics. Hot-melt extrusion, electrospinning, and microfluidic crystallization each offer new ways to generate amorphous dispersions, nanofibers, or uniform particles. Contributions on how these technologies move from pilot demonstrations to commercial production will likely form a significant share of the accepted papers.

For researchers, the timeline is concrete: manuscripts are due by June 30, 2026, with publication planned for January 2027 in the Journal of Pharmaceutical Investigation, and the guest editors based at Yonsei University, Pusan National University, and Duksung Women’s University will steer the peer review. For the wider industry, the issue lands at a moment when the pharmaceutical sector faces a convergence of pressures: increasingly insoluble molecules from discovery, a growing share of complex biologics requiring sophisticated delivery vehicles, supply chains under scrutiny, and regulators pushing for real-time assurance of quality. Particle engineering and formulation science sit squarely at the center of those pressures. The medicines of the next decade will succeed or fail not only on the biology of their targets but on the size, shape, and solid form of their particles, and a dedicated venue for translational advances in that discipline is a bet that the field’s next breakthroughs will come from the unglamorous but decisive work of turning molecules into manufacturable medicine.

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