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

A 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. Scheduled for publication in January 2027, the issue, titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, will gather research on how the physical form of a drug particle can determine whether a promising compound ever reaches patients. The announcement, made by the journal’s editorial team, carries a submission deadline of June 30, 2026, and is being coordinated by three guest editors based at South Korean universities: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University.

The premise underlying the special issue is deceptively simple. A drug molecule cannot act until it dissolves, and whether it dissolves depends on properties such as crystal structure, particle size, surface characteristics, and the formulation matrix that surrounds it. Industry estimates have long suggested that a large fraction of newly discovered drug candidates, particularly the poorly water-soluble small molecules that dominate modern discovery pipelines, fail not because they lack biological activity but because they cannot be delivered effectively to the site of action. Particle engineering, the deliberate manipulation of a drug’s physical state at scales ranging from nanometers to millimeters, has emerged as one of the most powerful levers for rescuing such compounds.

The scope of the issue reflects the breadth of that effort. Among the topics the editors have identified are particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies spanning oral, injectable, inhalable, and transdermal dosage forms; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies; and the application of Quality by Design and Process Analytical Technology, known respectively as QbD and PAT, in pharmaceutical formulation and manufacturing. Together, these themes trace the full arc of a drug product’s life, from the first manipulation of a powder to the validated, regulated production line that ships it to pharmacies.

Solubility enhancement is perhaps the most visible of these themes. When a drug’s crystals are milled down to the nanoscale, the dramatic increase in surface area per unit mass accelerates dissolution and can raise the concentration gradient that drives absorption across intestinal walls. Techniques such as wet media milling, high-pressure homogenization, and spray drying are now standard tools in the formulation scientist’s arsenal. Beyond size reduction, engineers can convert a crystalline drug into an amorphous solid dispersion, in which the molecule is trapped in a glassy polymer matrix with higher free energy and therefore greater apparent solubility. Each of these strategies involves trade-offs, since amorphous forms tend to recrystallize over time and nanoparticles can agglomerate, which is why stability and solid-state control appear alongside solubility in the issue’s topic list.

Solid-state science occupies a central place in the agenda because the same molecule can exist in multiple crystalline forms, or polymorphs, each with distinct melting points, dissolution rates, and mechanical properties. The consequences of ignoring this complexity are not hypothetical. Polymorph transitions discovered after a product reaches the market have historically triggered recalls, reformulations, and in some cases the loss of patent protection. Modern characterization relies on techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance to fingerprint each form and monitor whether processing steps like granulation, drying, or tableting inadvertently convert one form into another. The special issue’s emphasis on characterization and control signals that regulatory expectations around these analyses continue to rise.

The translational dimension of the issue is equally significant. A formulation that performs brilliantly in a laboratory beaker is worthless if it cannot be manufactured reproducibly at industrial scale. Scale-up introduces problems that rarely appear at bench scale: powder flow behavior in large hoppers, blend uniformity across thousands of kilograms, heat and mass transfer limitations in fluid-bed dryers, and the shear sensitivity of biologics in industrial mixers. Translational formulation science addresses the gap between discovery-stage proof of concept and the commercial drug product, asking whether a nanosuspension can be sterilized, whether a hot-melt extruded tablet can be pressed at production speed, and whether an inhaled powder retains its aerodynamic performance after months of storage in a humid climate.

Emerging manufacturing technologies form another pillar of the call for papers. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than sitting in batches, has gained regulatory acceptance in recent years and offers tighter process control, smaller facility footprints, and faster response to demand. Additive manufacturing, or three-dimensional printing, has already produced an approved orodispersible tablet and opens the door to personalized dosing in which a pill’s geometry and drug load are tailored to an individual patient. Other technologies, including electrospinning for nanofiber mats, supercritical fluid processing for solvent-free particle production, and microfluidic platforms for uniform lipid nanoparticles, are reshaping what dosage forms can look like and how they are made.

The inclusion of Quality by Design and Process Analytical Technology in the topic list underscores how deeply regulatory philosophy has become intertwined with formulation science. QbD, formalized in international guidance, asks developers to define the quality attributes a product must have, identify the process parameters and material properties that control those attributes, and build a design space within which the product is guaranteed to meet specifications. PAT supplies the real-time analytical eyes that make such control possible: near-infrared spectroscopy probes embedded in blenders, Raman sensors watching granulation in progress, and feedback loops that adjust process parameters on the fly. Together they replace the old paradigm of testing quality into a finished batch with the modern goal of building it in from the start.

The range of dosage forms covered by the issue, from oral tablets to injectables, inhalables, and transdermal systems, reflects the diversification of delivery science itself. Inhaled formulations demand particles with precisely tuned aerodynamic diameters, typically in the range of one to five micrometers, to deposit in the deep lung. Transdermal patches must balance drug permeability with adhesive performance and skin tolerability. Injectable depots and long-acting formulations can sustain therapeutic levels for weeks or months from a single administration, a capability that has transformed treatment adherence in fields from antipsychotic therapy to HIV prevention. Each route imposes its own particle and formulation constraints, and advances in one domain frequently cross-pollinate the others.

With a submission window running through June 30, 2026, and publication planned for January 2027, the special issue arrives at a moment when the pharmaceutical industry faces mounting pressure from increasingly complex molecules, including the lipid nanoparticles that carried mRNA vaccines into global prominence. The guest editors, drawing on their institutions’ long records in formulation research, are positioning the journal as a venue where laboratory innovation and manufacturing reality meet. For researchers working at that intersection, the issue represents an opportunity to demonstrate that the path from molecule to medicine is not an afterthought of discovery but a discipline in its own right, one whose advances determine whether scientific breakthroughs ever become therapies patients can actually take.

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

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