Particle Engineering Moves From Lab Bench to Pharmacy Shelf

Pharmaceutical science is quietly undergoing one of its most consequential transformations in decades, and much of it is happening at a scale so small that a single grain of dust would dwarf the particles involved. A forthcoming special issue of the Journal of Pharmaceutical Investigation, scheduled for publication in January 2027, is set to gather the latest translational advances in dosage form development built on particle engineering and formulation science. Guest 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 aims to bridge a stubborn gap that has long separated elegant laboratory discoveries from medicines patients can actually use. With a submission deadline of June 30, 2026, the editors are soliciting work that demonstrates not just novelty, but manufacturability, regulatory readiness, and clinical relevance.

The central problem the special issue addresses is deceptively simple to state and notoriously hard to solve: a large fraction of new drug candidates emerging from discovery pipelines dissolve poorly in water, and therefore poorly in the human body. Estimates across the industry consistently suggest that the majority of small-molecule compounds in development pipelines are classified as poorly soluble, a property that can render even a pharmacologically potent molecule therapeutically useless. When a drug cannot dissolve in gastrointestinal fluids, it cannot cross biological membranes in sufficient quantity to reach its target. Particle engineering attacks this bottleneck directly, because the rate at which a particle dissolves depends on its surface area, its crystalline form, and the energy state of the solid material itself.

Reducing particle size is the most intuitive of these strategies, and technologies such as wet milling and high-pressure homogenization have been refined over decades to push active ingredients into the nanometer range. At that scale, surface-area-to-volume ratios increase dramatically, and dissolution accelerates accordingly. But size reduction is only the opening move. Nanocrystal suspensions are thermodynamically unstable systems that tend to aggregate and grow over time, a phenomenon known as Ostwald ripening, so stabilizers must be selected with the same rigor as the drug itself. The choice of polymer or surfactant, its concentration, and its interaction with the particle surface determine whether a nanocrystal formulation survives months of storage and the acidic, turbulent journey through the digestive tract.

Beyond size, the solid state of a drug offers another powerful lever. Many active pharmaceutical ingredients exist in multiple crystalline forms, or polymorphs, each with distinct solubility, stability, and mechanical properties. An amorphous solid dispersion, in which the drug is molecularly dispersed in a glassy polymer matrix, can achieve apparent solubilities several times higher than the most stable crystal form. Yet amorphous materials carry an inherent tension: the very molecular mobility that gives them their solubility advantage also drives recrystallization during storage. Formulation scientists must therefore engineer the polymer-drug interaction, often quantified through the drug-polymer miscibility and the glass transition temperature of the blend, to lock the disordered state in place for the product’s entire shelf life. Hot-melt extrusion and spray drying, the two dominant manufacturing routes for these systems, each impose their own constraints on thermal exposure, solvent handling, and scalability.

What distinguishes the current wave of research from earlier generations of formulation work is its translational orientation. The special issue’s stated scope explicitly covers the scale-up of drug products and emerging manufacturing technologies in commercial production, signaling that the editors want studies that survive contact with real equipment and regulatory scrutiny. A nanocrystal process that works beautifully in a one-liter beaker may fail catastrophically in a hundred-liter vessel, where mixing times, heat transfer, and shear profiles differ fundamentally. Translational formulation science asks these questions early: can the process be run continuously, can its outputs be monitored in real time, and can its critical quality attributes be predicted and controlled rather than discovered after the fact?

That last question points to two frameworks that have reshaped pharmaceutical development over the past two decades: Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, or PAT. QbD inverts the traditional development paradigm. Instead of fixing a formulation and testing whether it works, developers first define the quality target product profile, identify the critical quality attributes that matter to safety and efficacy, and then systematically map how material properties and process parameters influence those attributes. The result is a design space, a multidimensional region of operating conditions within which quality is assured by design rather than verified by end-product testing alone. PAT supplies the instrumentation that makes this vision operational, embedding near-infrared spectroscopy, Raman probes, and other inline sensors directly into manufacturing lines so that particle size, blend uniformity, and moisture content can be tracked continuously during production.

The scope of the special issue extends well beyond oral tablets and capsules. The editors list injectable, inhalable, and transdermal dosage forms among the formulation strategies of interest, alongside advanced drug delivery systems more broadly. Each route imposes its own particle-level demands. Inhaled medicines, for example, require particles engineered to a narrow aerodynamic diameter range, typically between one and five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable suspensions must balance particle size against syringeability and avoid triggering immune responses. Transdermal systems depend on drug properties, vehicle design, and sometimes permeation enhancers to push molecules across the stratum corneum, the skin’s formidable outer barrier. The unifying thread is that in every case, the physical form of the drug and its excipients is not a detail but the core of the therapeutic design.

Solid-state characterization deserves particular attention in this landscape, because you cannot control what you cannot measure. Modern pharmaceutical development deploys an arsenal of analytical techniques to interrogate the solid state: powder X-ray diffraction to identify crystalline phases, differential scanning calorimetry to map thermal transitions, dynamic vapor sorption to probe hygroscopicity, and spectroscopic methods to detect molecular-level interactions between drug and polymer. Increasingly, computational approaches complement these tools, with molecular dynamics simulations and machine learning models used to predict miscibility, crystallization tendency, and formulation stability before a single experiment is run. The special issue’s emphasis on characterization and control reflects a regulatory environment that increasingly expects developers to understand their products at this mechanistic depth.

The timing of the initiative is significant. The pharmaceutical industry is simultaneously confronting a wave of increasingly difficult molecules, including high-molecular-weight biologics, peptide drugs, and poorly soluble small molecules, while also facing pressure to modernize manufacturing through continuous processing and digitalization. Formulation science sits at the intersection of these pressures. A well-engineered particle can rescue a failing compound, extend a product’s patent life through improved delivery, reduce dosing frequency, and cut manufacturing costs. Conversely, a formulation that cannot be scaled reliably can strand hundreds of millions of dollars of discovery investment. The guest editors’ institutions, spanning academia in Korea, reflect the growing role of Asian pharmaceutical research in this field, and the Journal of Pharmaceutical Investigation has positioned itself as a venue where such translational work is evaluated with industrial rigor.

For researchers considering submission, the message embedded in the issue’s scope is clear: the field has matured past the point where a clever solubility trick in a flask constitutes an advance. The contributions that will matter are those that connect particle-level engineering to dosage-form performance, connect formulation design to manufacturing reality, and connect both to the regulatory frameworks that govern whether a medicine can reach patients. The June 30, 2026 deadline gives teams roughly a year and a half to assemble such evidence, and the January 2027 publication date will place the collected work at a moment when the industry’s demand for manufacturable, science-driven formulation strategies has never been higher. In a discipline where the difference between success and failure can be measured in nanometers and crystal lattices, that kind of systematic, translational attention may prove to be the most important ingredient of all.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for drug 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, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, nanocrystals, amorphous solid dispersions, scale-up, pharmaceutical manufacturing, dosage forms