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

A new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation, with a focus on how particle engineering and formulation science are transforming laboratory discoveries into medicines patients can actually use. Scheduled for publication in January 2027 and edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, the issue invites contributions across six interlocking themes: particle engineering for solubility and bioavailability, advanced formulation strategies for oral, injectable, inhalable and transdermal dosage forms, solid-state characterization and control, translational formulation science and scale-up, emerging manufacturing technologies, and the application of Quality by Design and Process Analytical Technology in formulation and manufacturing. With a submission deadline of June 30, 2026, the issue arrives at a moment when the pharmaceutical industry faces mounting pressure to develop formulations for increasingly difficult molecules while keeping manufacturing robust, economical and regulator-friendly.

The underlying problem that unites these themes is deceptively simple to state and brutally hard to solve. A large share of drug candidates emerging from discovery pipelines are poorly soluble in water, which means that even a chemically potent molecule may fail to reach therapeutic concentrations in the bloodstream. When a solid drug particle dissolves too slowly, the body simply cannot absorb it fast enough, and the compound is abandoned despite its pharmacological promise. Particle engineering attacks this bottleneck at its physical root by manipulating crystal form, particle size, shape and surface properties to accelerate dissolution and improve how the drug interacts with its surroundings. Techniques such as micronization, nanosizing, amorphous solid dispersion and controlled crystallization can increase the effective surface area available for dissolution by orders of magnitude, converting a marginal molecule into a viable medicine.

The science here is more intricate than simply grinding crystals finer. Reducing particle size increases surface area, but it also raises the material’s surface free energy, which drives tiny particles to aggregate and can even destabilize the solid state itself. Amorphous materials, which lack the orderly lattice of crystals, offer higher apparent solubility because the crystal lattice no longer consumes energy during dissolution, yet they are thermodynamically inclined to revert to a more stable crystalline form, a process called recrystallization that can erase the solubility advantage overnight. Stabilizing amorphous dispersions typically requires polymeric carriers that hydrogen-bond with the drug molecule and raise the energy barrier to reorganization, and predicting which drug-polymer pair will remain stable on the shelf for years is an active frontier of computational and experimental research. The special issue’s emphasis on solid-state characterization reflects this reality: knowing precisely whether a drug is crystalline, amorphous, or a hydrate, and detecting any transformation before it compromises a product, is foundational to every downstream decision.

Formulation strategies extend far beyond solubility. The invited topics span oral tablets and capsules, injectable suspensions, inhalable powders and transdermal systems, each with its own demands on particle properties. An inhaled medicine, for example, must have particles in a narrow aerodynamic range, roughly one to five micrometers, to navigate past the throat and deposit deep in the lungs, and their surface chemistry must prevent cohesive clumping in a dry-powder inhaler. An injectable suspension must remain physically stable without clogging needles or sedimenting irreversibly in the vial. A transdermal patch relies on controlled release through polymeric matrices and adhesion science as much as on the drug itself. By framing advanced drug delivery systems alongside conventional dosage forms, the editors are signaling that translational progress means engineering particles for the specific route, device and physiology a therapy demands rather than optimizing in a vacuum.

Translational formulation science, arguably the heart of the issue, addresses the notorious valley between an elegant laboratory experiment and a dependable commercial product. A formulation that performs beautifully at the two-milligram scale of a bench-top rotor can behave entirely differently in a kilogram-scale high-shear granulator or a continuous manufacturing line. Mixing efficiency, heat transfer, drying kinetics and flow behavior all shift with scale, and unanticipated shifts can change crystal form, particle size distribution or blend uniformity in ways that alter bioavailability. Scale-up therefore requires predictive models, careful process mapping and analytical methods sensitive enough to catch drift early. Case studies in this area carry particular value for the field, because they document not only successes but the failure modes and corrective reasoning that rarely appear in methods papers yet are essential for training the next generation of formulation scientists.

Emerging manufacturing technologies are reshaping what is possible in that translation. Continuous manufacturing, in which raw materials flow through an uninterrupted sequence of unit operations, replaces the traditional batch model with smaller footprints, tighter process control and the ability to adjust production volume more nimbly. Hot-melt extrusion continues to expand as a solvent-free route to amorphous solid dispersions, while additive manufacturing, including three-dimensional printing, enables dosage forms with geometrically programmed release profiles that conventional tableting cannot achieve. Technologies such as spray drying and supercritical fluid processing give formulators additional levers over particle morphology and residual solvent content. The special issue’s inclusion of commercial production among its topics underscores a point that regulators and industry leaders have emphasized for years: a breakthrough formulation only matters to patients if it can be manufactured reproducibly, at cost, at scale.

Quality by Design and Process Analytical Technology provide the methodological spine that holds these advances together. Quality by Design, a regulatory philosophy embraced by agencies worldwide, asks developers to define the quality target of a product in advance, identify which material attributes and process parameters critically influence that target, and build control strategies around that understanding rather than relying on end-product testing alone. Process Analytical Technology supplies the eyes and ears of this approach: inline and at-line sensors, such as near-infrared spectroscopy and Raman spectroscopy, monitor blend uniformity, moisture content and polymorphic form in real time, allowing operators to detect and correct deviations while the process is running. Together, these frameworks convert formulation development from a largely empirical art into a knowledge-driven engineering discipline, and their application to next-generation particle engineering is precisely the kind of integration the special issue seeks.

The roster of guest editors offers a clue to the issue’s translational orientation. Hwang, of Yonsei University, is widely known for work on pharmaceutical formulation and drug delivery systems spanning conventional and advanced dosage platforms. Kim, at Pusan National University, has published extensively on particle engineering, supersaturating drug delivery systems and amorphous formulations. Park, of Duksung Women’s University, brings expertise in formulation development and solid-state science. A Korean-led editorial team convening international contributors is fitting given the region’s prominent role in pharmaceutical manufacturing innovation, and the Journal of Pharmaceutical Investigation, published by Springer, has long served as a venue where Asian and global pharmaceutical sciences communities intersect. Researchers interested in contributing have until June 30, 2026, to submit manuscripts for consideration.

For patients, the stakes of this technical agenda are concrete. Medicines that dissolve predictably, remain stable in hot climates without refrigeration, arrive in devices patients can use correctly, and are manufactured with built-in quality controls translate directly into fewer treatment failures, fewer recalls and faster access to new therapies. As drug molecules grow larger, more insoluble and more biologically targeted, the discipline of particle engineering and formulation science has quietly become one of the decisive battlegrounds of pharmaceutical innovation, determining which discoveries survive the journey from molecule to medicine. The January 2027 special issue promises a consolidated look at how that battle is being won, from the nanoscale behavior of a single crystal to the continuous production lines that deliver billions of doses a year, and it arrives at a time when the field’s importance to global health has never been clearer.

Subject of Research: Translational pharmaceutical formulation 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

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility, bioavailability, solid-state characterization, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, amorphous solid dispersion, pharmaceutical manufacturing