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

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 January 2027 publication date that its editors hope will capture a field in the middle of a translational sprint. The issue, titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, is being curated by three South Korean pharmaceutical scientists: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Their call for papers, with a submission deadline of June 30, 2026, lays out an agenda that reads like a map of where drug delivery research is heading, from nanoscale particle design to the industrial machinery that turns laboratory breakthroughs into medicines patients can actually swallow, inhale, inject, or wear on their skin.

The central problem the special issue addresses is one of the oldest in pharmacology: a molecule can be a brilliant drug in theory and nearly useless in practice if the human body cannot absorb it. Industry estimates have long suggested that a large fraction of newly discovered active pharmaceutical ingredients fall into the poorly water-soluble category, particularly the bulky, lipophilic molecules that emerged from high-throughput screening and structure-based drug design over the past two decades. Particle engineering attacks this problem at its physical roots. By reducing drug particles to the micrometer or nanometer scale, formulators dramatically increase the surface area available for dissolution, and since a drug must dissolve in gastrointestinal or bodily fluids before it can cross biological membranes, that increase in surface area can translate directly into higher bioavailability. Techniques such as wet milling, high-pressure homogenization, supercritical fluid processing, and spray drying have each matured into reliable industrial tools, and the special issue explicitly invites submissions on particle engineering approaches for solubility, stability, and bioavailability enhancement.

But particle size is only the beginning of the story. The solid state of a drug, meaning the specific arrangement of its molecules in a crystal or an amorphous matrix, can matter as much as its size. Many drugs crystallize in multiple polymorphic forms, each with a distinct lattice energy and therefore a distinct solubility, melting point, and stability profile. The most thermodynamically stable form is usually the safest choice for a commercial product because it will not spontaneously convert to something less soluble on the pharmacy shelf, yet it is often the least soluble option available. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer carrier, offer a way to lock in the higher energy, higher solubility state, but they carry their own risk of recrystallization over time. The special issue’s emphasis on solid-state characterization and control reflects how central this balancing act has become. Modern analytical techniques, including powder X-ray diffraction, differential scanning calorimetry, solid-state nuclear magnetic resonance, and Raman spectroscopy, now allow scientists to peer into these molecular arrangements with a precision that was unthinkable a generation ago.

The scope of dosage forms under consideration is deliberately broad. The editors list oral, injectable, inhalable, and transdermal formulations among their target topics, alongside advanced drug delivery systems more generally. Each of these routes imposes its own engineering constraints. Oral solids must survive the acidic environment of the stomach and release their payload at the right point in the intestine. Injectable formulations must be sterile, isotonic, and free of particles that could trigger immune reactions, which places unusually strict demands on filtration and particle size distribution. Inhaled medicines must generate aerosol droplets or dry powder particles in a narrow aerodynamic size range, typically around one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push molecules through the stratum corneum, the skin’s remarkably effective barrier, using chemical permeation enhancers, microneedles, or electrical assistance. A formulation scientist working across these domains needs a toolkit that spans colloid chemistry, materials science, and biopharmaceutics, and the special issue is designed to showcase exactly that breadth.

What distinguishes this particular call for papers from many academic collections is the word translational. The editors are not merely asking for elegant laboratory demonstrations; they want work that moves toward the clinic and the manufacturing floor. One of their listed topics is translational formulation science and scale-up of drug products, a phrase that encompasses one of the most persistent pain points in pharmaceutical development. A formulation that performs beautifully when mixed in a one-liter beaker may behave entirely differently in a thousand-liter industrial vessel, where mixing times, heat transfer, and drying kinetics scale in nonlinear ways. Spray drying, for example, depends on droplet evaporation rates that change with chamber geometry and airflow patterns, and a process optimized at laboratory scale can produce particles with different residual moisture, morphology, and crystallinity when scaled up. Bridging that gap requires careful process modeling, statistically designed experiments, and a deep understanding of how each unit operation shapes the final product.

This is where the special issue’s interest in emerging manufacturing technologies becomes particularly timely. Continuous manufacturing, in which raw materials flow through an integrated production line rather than moving in discrete batches, has been steadily gaining regulatory acceptance and industrial adoption. For pharmaceutical solids, continuous manufacturing often means connecting feeders, blenders, twin-screw extruders, and dryers into a single train whose output can be monitored and adjusted in real time. Hot-melt extrusion, a related technology, has become a workhorse for producing amorphous solid dispersions, since the drug and polymer are melted and mixed together under controlled shear and then rapidly cooled into a homogeneous glass. Additive manufacturing, or three-dimensional printing, has opened the possibility of dosage forms with complex internal geometries and personalized doses, an approach that received a landmark regulatory approval when the first printed drug product reached the market in the United States. Electrospinning, microfluidics, and supercritical antisolvent crystallization round out a portfolio of techniques that were laboratory curiosities two decades ago and are now edging toward commercial reality.

Underpinning all of this manufacturing ambition is a regulatory philosophy that has reshaped the industry: Quality by Design, commonly abbreviated as QbD. Rather than testing finished products to catch defects, QbD asks developers to build quality into the product from the start, by identifying the critical quality attributes that determine clinical performance, understanding which process parameters and material properties influence those attributes, and establishing a design space within which the product is guaranteed to meet its specifications. Paired with Process Analytical Technology, or PAT, which deploys inline and online sensors such as near-infrared spectroscopy to monitor the process as it runs, QbD turns formulation development from an empirical craft into an engineering science. The special issue explicitly invites work on QbD and PAT applications in pharmaceutical formulation and manufacturing, signaling that the editors see data-rich, model-driven development as the standard against which future research will be judged.

The timing of the issue, arriving in early 2027, positions it to synthesize a period of unusual ferment in the field. The explosion of biologics, antibody-drug conjugates, and mRNA therapeutics has created delivery challenges that small-molecule formulation science never faced, from stabilizing proteins against aggregation to encapsulating fragile genetic cargo in lipid nanoparticles. At the same time, the enduring importance of small molecules means that classical particle engineering remains as relevant as ever, and hybrid approaches that combine nanocarriers with engineered crystals are blurring the line between the two traditions. Regulatory agencies worldwide have also intensified their scrutiny of drug product quality, pushing companies to invest in deeper mechanistic understanding of their formulations. A collection of peer-reviewed papers that documents these converging pressures, with concrete examples of formulations that have made the journey from bench to bedside, could serve as a valuable reference for both academic researchers and industrial scientists.

For the three guest editors, the special issue represents an opportunity to consolidate a research community that spans universities, generic and innovative drug manufacturers, and equipment makers. Hwang, Kim, and Park each bring backgrounds in pharmaceutics and drug delivery research within the Korean academic system, and their institution affiliations reflect the strength of South Korea’s pharmaceutical sciences programs, which have become increasingly prominent in formulation and drug delivery research. The Journal of Pharmaceutical Investigation, published by Springer, has historically served as a venue for work bridging Asian pharmaceutical research and the international community, making it a fitting home for an issue that aims to be globally relevant. Researchers interested in contributing have until the end of June 2026 to prepare manuscripts, and the breadth of the listed topics suggests the editors expect submissions ranging from fundamental crystallography to full-scale process validation studies.

The larger significance of this effort lies in a truth that the pharmaceutical industry has long understood but the public rarely sees: the dosage form is not an afterthought to the drug, it is the drug, at least as far as the patient is concerned. A molecule that cannot be formulated into a stable, manufacturable, patient-acceptable product will never help anyone, no matter how promising its biology. Particle engineering and formulation science are the disciplines that close that gap, converting molecular potential into therapeutic reality. By dedicating an entire special issue to the translational end of that pipeline, the Journal of Pharmaceutical Investigation is betting that the next few years will produce advances worth documenting in detail, and given the pace of innovation in continuous manufacturing, nanoscale engineering, and quality-driven development, that bet looks well placed.

Subject of Research: Translational pharmaceutical dosage form development through 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

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, continuous manufacturing, amorphous solid dispersions, scale-up, pharmaceutical manufacturing, dosage forms