Particle Engineering Takes Center Stage as Pharmaceutical Scientists Push Dosage Forms From Lab to Market

A major new special issue of the Journal of Pharmaceutical Investigation is set to spotlight one of the most consequential yet underappreciated frontiers in modern medicine: the science of turning molecules into medicines that actually work in patients. Titled “Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science,” the special issue will be published in January 2027, with a submission deadline of June 30, 2026. It is being assembled by three guest editors from leading Korean institutions: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Together they are inviting contributions that span the full journey of a drug product, from the manipulation of individual particles to the industrial scale-up of finished dosage forms.

The premise behind the special issue is deceptively simple. A drug molecule, no matter how elegant its biological mechanism, is useless if it cannot be dissolved, absorbed, and delivered at the right place and time in the body. Estimates across the pharmaceutical industry have long suggested that a large fraction of newly discovered drug candidates suffer from poor aqueous solubility, a property that can doom a promising compound before it ever reaches the clinic. Particle engineering, the deliberate design of a drug’s physical form at scales ranging from nanometers to millimeters, has emerged as one of the most powerful responses to this challenge. By controlling crystal habit, particle size distribution, surface properties, and solid-state form, formulation scientists can transform a poorly behaving molecule into a commercially viable medicine.

The topics outlined for the special issue read like a map of the field’s current priorities. The first listed theme concerns particle engineering approaches for enhancing solubility, stability, and bioavailability. This encompasses a family of techniques that have matured dramatically over the past two decades. Nanocrystal technology, for instance, reduces drug particles to sizes so small that their increased surface area and altered dissolution thermodynamics dramatically accelerate the rate at which they dissolve in gastrointestinal fluids. Several nanocrystal-based products have already reached the market, validating the approach as more than a laboratory curiosity. Amorphous solid dispersions take a different route, locking a drug into a disordered, high-energy glassy state in which it lacks the crystal lattice that normally impedes dissolution. The trade-off is physical instability, since amorphous materials tend to recrystallize over time, and controlling that risk is a central concern of modern preformulation research.

A second theme addresses advanced formulation strategies across the full spectrum of dosage routes: oral, injectable, inhalable, transdermal, and other delivery systems, along with advanced drug delivery platforms. Each route imposes its own engineering demands. Oral solid dosage forms, still the dominant category worldwide, must survive manufacturing stresses, storage conditions, and the harsh environment of the digestive tract before releasing their payload. Injectable formulations face the opposite constraints, demanding sterility, isotonicity, tolerability at the injection site, and often long-term stability in liquid form. Inhalable products must generate aerosol droplets or dry powder particles within a narrow aerodynamic size window, typically around one to five micrometers, so that they deposit in the deep lung rather than in the mouth or throat. Transdermal systems must push molecules across the skin, the body’s most effective barrier, using chemical enhancers, microneedles, or other permeation strategies. The special issue’s scope signals that translational insight is expected across all of these modalities rather than in a single niche.

Solid-state characterization and control form the third pillar of the announced scope. The solid form a drug adopts, whether a polymorph, a salt, a cocrystal, a hydrate, or an amorphous phase, governs its dissolution behavior, its mechanical properties during tableting, its tendency to degrade, and its stability on the shelf. The regulatory and commercial stakes are enormous: a single undocumented polymorph transition can alter a product’s performance and has historically triggered litigation and supply disruptions. Modern characterization relies on a battery of techniques, including powder X-ray diffraction to identify crystal structures, differential scanning calorimetry to map thermal transitions, dynamic vapor sorption to probe hygroscopicity, and spectroscopic methods such as Raman and solid-state nuclear magnetic resonance to resolve subtle molecular arrangements. Increasingly, computational crystal structure prediction and machine learning are being layered on top of these experimental tools to anticipate which forms a molecule can adopt and which are most likely to appear during development.

Translational formulation science and the scale-up of drug products constitute the fourth theme, and arguably the one that most directly defines the special issue’s ambition. Moving a formulation from a bench-top beaker to a commercial manufacturing line is notoriously fraught. A suspension that mixes perfectly at one liter may segregate or shear-degrade at one thousand. A spray-drying process optimized on a laboratory unit may produce particles with different residual moisture and morphology at pilot scale. Dissolution profiles that look acceptable in early development can shift as equipment, batch size, and process parameters change. Translational research in this area seeks predictive frameworks, whether based on dimensional analysis, computational fluid dynamics, discrete element modeling, or mechanistic dissolution theory, that allow scientists to anticipate how a formulation will behave as it scales, reducing the number of costly trial-and-error campaigns and the risk of late-stage failures.

Emerging manufacturing technologies make up the fifth announced topic, and this is where the field’s most visible transformation is underway. Additive manufacturing, particularly fused deposition modeling and semisolid extrusion printing, has opened the possibility of dosage forms with customized geometries, drug release kinetics, and even patient-specific doses printed on demand. Continuous manufacturing, in which raw materials flow through an uninterrupted sequence of unit operations rather than being processed in discrete batches, promises tighter quality control, smaller facility footprints, and faster response to demand. Hot-melt extrusion, electrospinning, supercritical fluid processing, and microfluidic nanoparticle production each offer distinctive routes to engineered particles that conventional milling or crystallization cannot achieve. The special issue’s inclusion of commercial production among its interests indicates that the editors want papers demonstrating not just novelty at the bench but feasibility at industrial throughput.

The sixth theme, applications of Quality by Design and Process Analytical Technology, ties the entire enterprise to the regulatory philosophy that now governs pharmaceutical development worldwide. Quality by Design, or QbD, reframes drug development as a systematic exercise in understanding: developers must identify the quality attributes that matter to patients, determine the formulation and process variables that control those attributes, and establish a design space within which the product reliably meets its specifications. Process Analytical Technology, or PAT, supplies the real-time measurement tools that make such control practical, including near-infrared spectroscopy for monitoring blend uniformity, Raman probes for tracking polymorphic form during drying, and inline particle size analysis during crystallization. Together, QbD and PAT shift quality assurance from testing finished products at the end of a line to building quality into the process itself, an approach regulators in the United States, Europe, and elsewhere have actively promoted for nearly two decades.

What makes this special issue notable is its explicitly translational framing. Pharmaceutical journals frequently publish elegant studies of novel nanoparticles or exotic excipients that never progress beyond animal studies. By emphasizing scale-up, manufacturing technologies, and QbD alongside fundamental particle science, the guest editors are drawing a line from molecular-level engineering to the realities of commercial drug product development. That framing reflects a broader trend in the field, in which the boundary between formulation research and manufacturing science is dissolving. The same crystal form that determines a tablet’s dissolution also determines how it flows through a tablet press; the same particle size distribution that governs lung deposition also governs whether a dry powder inhaler can be manufactured reproducibly. Researchers who work at these interfaces, and who can demonstrate data at multiple scales, are precisely the contributors the issue appears designed to attract.

For the pharmaceutical sciences community, the timeline is concrete. Manuscripts are due by June 30, 2026, with publication of the completed issue scheduled for January 2027 in the Journal of Pharmaceutical Investigation, a peer-reviewed journal published by Springer that covers drug delivery, formulation, and pharmaceutical technology. The guest editors, based at Yonsei University, Pusan National University, and Duksung Women’s University in South Korea, bring institutional roots in some of the most active formulation science programs in Asia, a region whose pharmaceutical industry has grown rapidly in both generic and innovative drug product development. As poorly soluble molecules continue to dominate discovery pipelines and as regulators push for more predictive, more flexible, and more continuously monitored manufacturing, the questions this special issue addresses are not academic. They determine whether the next generation of medicines can be made at all, and whether the medicines already on pharmacy shelves can be made better, faster, and more reliably.

Subject of Research: Translational pharmaceutical dosage form development based on 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

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