Particle Engineering and Formulation Science Drive the Next Wave of Drug Delivery Innovation

The Journal of Pharmaceutical Investigation has announced a special issue devoted to translational advances in pharmaceutical dosage form development based on particle engineering and formulation science, scheduled for publication in January 2027. The issue will be guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three researchers based in South Korea whose institutions have been closely associated with pharmaceutical formulation research and drug delivery technology. Researchers have been invited to submit manuscripts by June 30, 2026, with contributions expected to span the full journey of a dosage form from laboratory concept to commercial product. The scope of the issue reflects a growing recognition within the pharmaceutical sciences that the physical form of a drug, and the way that form is engineered at the particle level, often determines whether a promising molecule ever becomes a usable medicine.

At the heart of the special issue lies a technical problem that has shadowed the pharmaceutical industry for decades: poor aqueous solubility. A large fraction of newly discovered drug candidates, particularly those emerging from high-throughput screening campaigns against intracellular targets, are hydrophobic small molecules whose dissolution in gastrointestinal fluids is slow and incomplete. Because a drug must dissolve before it can permeate biological membranes and reach systemic circulation, inadequate dissolution directly suppresses oral bioavailability. Particle engineering attacks this bottleneck by manipulating solid-state and particulate properties such as crystal habit, particle size distribution, surface area, and wettability. Reducing particle size into the micrometer or nanometer range increases the surface-area-to-volume ratio available for dissolution, and according to the Noyes-Whitney relationship the dissolution rate scales with this surface area, so comminution techniques including wet media milling, high-pressure homogenization, and spray drying have become standard tools in the formulation scientist’s arsenal.

Beyond simple size reduction, the special issue’s first listed topic, particle engineering approaches for solubility, stability, and bioavailability enhancement, encompasses more sophisticated solid-state interventions. Many drugs crystallize in multiple polymorphic forms, each with a distinct lattice energy and therefore a distinct solubility and dissolution profile. Amorphous solid dispersions, in which a drug is molecularly dispersed within a hydrophilic polymer carrier, can generate a metastable form with apparent solubility several-fold higher than the crystalline parent, although the trade-off is a persistent risk of physical instability and recrystallization during storage. Co-crystal engineering, salt formation, and hydrotropy offer alternative crystalline routes to improved solubility with potentially better thermodynamic robustness. Stability is the second pillar of this topic: a formulation that gains solubility at the expense of chemical or physical stability fails translationally, and the interplay between the two constraints is precisely the kind of problem the guest editors appear to want the issue to address.

The second topic area widens the lens to advanced formulation strategies across the principal routes of administration, including oral, injectable, inhalable, and transdermal dosage forms, together with advanced drug delivery systems. Each route imposes its own engineering demands. Oral solid dosage forms remain the dominant commercial format, and their design involves balancing disintegration, dissolution, permeation, and first-pass metabolism. Injectable formulations must satisfy stringent requirements for sterility, isotonicity, pH, and particulate burden, and long-acting injectable depots have become a major translational focus because they can sustain therapeutic plasma concentrations for weeks or months from a single administration. Inhalable products, whether pressurized metered-dose inhalers or dry powder inhalers, depend critically on aerodynamic particle diameter, with particles in the range of roughly one to five micrometers required to deposit in the deep lung rather than in the mouth and throat. Transdermal systems must overcome the formidable barrier of the stratum corneum, typically through passive diffusion optimization, chemical penetration enhancers, or physical approaches. The common thread is that particle and formulation science underpin all of these routes, which is why the issue treats them as a single integrated theme.

Solid-state characterization and control, the third topic, addresses the analytical backbone without which none of the preceding strategies can be reliably executed. Modern pharmaceutical development deploys an array of techniques to interrogate the solid state: powder X-ray diffraction to distinguish polymorphs and quantify crystallinity, differential scanning calorimetry to detect thermal transitions such as glass transition temperatures and melting events, dynamic vapor sorption to probe hygroscopicity, and spectroscopic methods including Raman and near-infrared analysis for rapid identification of solid-state forms. The translational challenge is not merely characterizing a form once but controlling it throughout development and manufacturing, because processing steps such as milling, granulation, and drying can induce unintended phase transformations. A drug product that leaves the factory as a stable crystalline polymorph may, under mechanical stress or humidity excursions, convert to a less desirable form with altered dissolution behavior, so the issue’s emphasis on control as well as characterization signals a quality-focused perspective.

The fourth topic, translational formulation science and scale-up of drug products, targets the notorious valley between the research bench and the production plant. A formulation that performs beautifully at the milligram scale in a laboratory mortar can behave entirely differently when produced in hundreds of kilograms on high-shear granulators, fluid-bed dryers, and rotary tablet presses. Scale-up introduces changes in mixing timescales, heat and mass transfer, and shear forces that can alter particle size distributions, content uniformity, and solid-state form. Translational formulation science seeks to anticipate these effects through mechanistic process understanding and through the use of computational tools, including process modeling and, increasingly, machine learning approaches that correlate formulation and process variables with critical quality attributes. For the pharmaceutical industry, failures at this stage are extraordinarily costly, since they surface late in development when clinical supplies and regulatory timelines are already committed, which explains why the guest editors have elevated scale-up to a headline theme of the issue.

Emerging manufacturing technologies constitute the fifth topic and represent perhaps the most dynamic frontier in dosage form design. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than being processed in discrete batches, has gained regulatory acceptance and offers advantages in footprint, inventory, and real-time quality assurance. Additive manufacturing, notably fused deposition modeling and semisolid extrusion three-dimensional printing, enables dosage forms with geometrically complex internal structures and, in principle, patient-specific doses. Hot-melt extrusion continues to expand as a solvent-free route to amorphous solid dispersions, while spray drying and supercritical fluid technologies provide alternative pathways for engineering particles with tailored morphology. Nanotechnology platforms, including lipid nanoparticles that achieved global prominence through messenger RNA vaccines, have demonstrated that particle engineering at the nanoscale can enable entirely new therapeutic modalities, and the special issue’s inclusion of emerging manufacturing technologies suggests an interest in how such platforms move from proof of concept to commercial production.

The sixth topic, applications of Quality by Design and Process Analytical Technology in pharmaceutical formulation and manufacturing, ties the entire issue to the regulatory and quality framework that governs modern drug development. Quality by Design, a paradigm formalized in guidance from major regulatory agencies, requires developers to define a quality target product profile, identify the critical quality attributes of the product, and establish the relationship between formulation and process parameters and those attributes, so that quality is designed into the product rather than tested in at the end. Process Analytical Technology supplies the real-time measurement capability that makes this vision operational: inline and online sensors such as near-infrared spectroscopy, Raman probes, and focused beam reflectance measurement allow manufacturers to monitor blend uniformity, granule growth, drying endpoint, and tablet properties as the process runs, rather than waiting for laboratory results on withdrawn samples. Together, QbD and PAT shift pharmaceutical manufacturing toward continuous verification and, ultimately, real-time release testing, and their integration with particle engineering is a natural pairing because particulate processes are notoriously sensitive to small perturbations in operating conditions.

The composition of the guest editorial team offers its own signal about the issue’s orientation. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research in Korea, and the involvement of Min-Soo Kim of Pusan National University and Heejun Park of Duksung Women’s University extends the editorial base across multiple Korean institutions with active formulation science programs. The Journal of Pharmaceutical Investigation, published by Springer, serves as an international venue for pharmaceutical research with a particular emphasis on drug delivery and formulation, and a special issue of this kind functions both as a snapshot of current priorities in the field and as a call to the global community to consolidate their translational findings. The June 30, 2026 submission deadline gives prospective authors roughly a year and a half from the announcement window to prepare manuscripts that meet the issue’s translational emphasis.

For readers outside the pharmaceutical sciences, the significance of this special issue lies in what it says about how medicines are actually made. The public narrative of drug development tends to center on molecular discovery, the search for the compound that binds the target, yet the interval between a potent molecule and a shelf-stable tablet, inhaler, or injection is bridged almost entirely by particle engineering and formulation science. A molecule that dissolves too slowly, crystallizes in the wrong form, aggregates in solution, or cannot be manufactured reproducibly at scale will never reach patients regardless of its pharmacological promise. By framing its call around solubility and bioavailability, solid-state control, scale-up, emerging manufacturing, and Quality by Design, the Journal of Pharmaceutical Investigation is spotlighting the discipline that converts chemistry into therapy, and the January 2027 issue is positioned to document how that conversion is becoming faster, more controlled, and more reliably translatable in the years ahead.

Subject of Research: Translational pharmaceutical dosage form development using 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, solubility enhancement, bioavailability, solid-state characterization, scale-up, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solid dispersions, Journal of Pharmaceutical Investigation