Particle Engineering Takes Center Stage in Push for Next-Generation Drug Dosage Forms

The world of modern medicine is increasingly defined not only by the molecules that pharmaceutical scientists discover, but by the ingenious ways those molecules are transformed into medicines patients can actually take. A new special issue of the Journal of Pharmaceutical Investigation aims to capture that transformation, gathering research on translational advances in pharmaceutical dosage form development based on particle engineering and formulation science. Scheduled for publication in January 2027, the issue is being assembled by three guest editors from South Korean universities: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Researchers have until June 30, 2026, to submit their work for consideration.

The premise behind the initiative is straightforward but consequential. Many of the most promising drug candidates emerging from discovery pipelines fail not because they lack biological activity, but because they dissolve poorly, degrade rapidly, or cannot be manufactured reliably at scale. Formulation science, the discipline that bridges a molecule’s inherent properties and a finished dosage form, has therefore become one of the most strategically important fields in the pharmaceutical industry. By focusing the special issue on particle engineering and formulation science, the editors are inviting contributions that span the entire journey from laboratory bench to commercial production, a journey often described as translational research because it translates scientific insight into therapies that reach patients.

At the heart of the call for papers lies particle engineering, a discipline devoted to designing the physical characteristics of drug particles: their size, shape, crystal form, surface properties, and degree of disorder. These attributes govern how a drug dissolves in the gastrointestinal tract, how deeply it penetrates the lungs when inhaled, how it disperses when injected, and how stable it remains on a pharmacy shelf. Reducing particle size to the micrometer or nanometer scale increases the surface area available for dissolution, which can dramatically improve the oral bioavailability of poorly water-soluble compounds. Industry estimates consistently suggest that a large share of new small-molecule candidates fall into this poorly soluble category, which explains why solubility enhancement has become a dominant theme in pharmaceutical research.

One of the six topic areas named in the call addresses particle engineering approaches for solubility, stability, and bioavailability enhancement. In practice, this encompasses a diverse arsenal of techniques. Milling and high-pressure homogenization can shatter crystals into nanoparticles, while spray drying can lock a drug into an amorphous solid dispersion, a glassy state in which molecules are frozen in random orientations rather than arranged in an orderly crystal lattice. The amorphous form dissolves faster and more completely than its crystalline counterpart, but it carries a vulnerability: given enough time, temperature, or humidity, the molecules tend to revert to the more stable crystal structure, eroding the solubility advantage. That instability leads directly to another topic in the special issue, solid-state characterization and control.

Solid-state science concerns the polymorphic forms a drug molecule can adopt. The same chemical entity can crystallize into multiple arrangements, each with its own melting point, dissolution rate, mechanical behavior, and thermodynamic stability. Regulators expect developers to identify which form is being manufactured and to prove that it remains that form throughout the product’s shelf life. Analytical tools such as powder X-ray diffraction, differential scanning calorimetry, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint these forms and monitor whether unwanted transformations occur during processing. The special issue’s emphasis on solid-state characterization and control reflects a growing recognition that the crystal is not a static backdrop but an active variable in drug performance and regulatory approval.

A second pillar of the call is advanced formulation strategies for pharmaceutical dosage forms and advanced drug delivery systems. The editors explicitly span oral, injectable, inhalable, and transdermal routes, each of which imposes its own engineering constraints. Oral tablets must survive the acidic environment of the stomach and release their payload at the right location. Injectable formulations must be sterile, isotonic, and free of particles that could trigger immune reactions. Inhaled medicines demand aerodynamic particle sizes in a narrow window, typically a few micrometers, so that the droplets or powder particles can reach the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must coax large molecules through a skin barrier that evolved precisely to keep foreign substances out. Conquering any one of these challenges requires a synthesis of materials science, biophysics, and process engineering.

Beyond conventional dosage forms, the call for papers embraces advanced drug delivery systems, a category that includes nanocarriers, controlled-release architectures, and other platforms designed to deliver a drug to the right place at the right time. Such systems can reduce dosing frequency, smooth out dangerous peaks in blood concentration, and concentrate therapeutic effects in diseased tissue while sparing healthy organs. The translational framing of the issue is significant here: elegant delivery concepts abound in academic literature, yet only a fraction ever survive the realities of clinical testing, regulatory scrutiny, and cost-effective mass production. Highlighting translational formulation science and the scale-up of drug products, the special issue explicitly invites research that addresses that difficult passage from proof of concept to patient use.

Scale-up is where many formulation breakthroughs meet their sternest test. A mixing process that works flawlessly in a beaker may behave entirely differently inside a multi-hundred-liter industrial vessel, where heat transfer, shear forces, and drying rates scale non-linearly. Continuous manufacturing, in which product flows steadily through connected unit operations rather than being produced in discrete batches, is emerging as a response to these challenges and fits squarely within the issue’s sixth named topic: emerging manufacturing technologies in dosage form design and commercial production. Additive manufacturing, sometimes described as three-dimensional printing of medicines, hot-melt extrusion, and novel crystallization methods all belong to this conversation, offering ways to create complex dosage forms with properties that conventional equipment cannot achieve.

The final topic area announced by the editors concerns Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT. Quality by Design is a regulatory philosophy, championed by agencies such as the United States Food and Drug Administration, that asks manufacturers to build quality into a product by design rather than testing it in afterwards. Developers systematically map how formulation variables and process parameters affect critical quality attributes, then establish a design space within which the product reliably meets its specifications. Process Analytical Technology provides the sensory apparatus for this vision: real-time instruments such as near-infrared spectroscopy and Raman spectroscopy embedded directly in the production line, monitoring blend uniformity, granule moisture, or tablet hardness without halting the process. Together, QbD and PAT promise shorter development timelines, fewer product failures, and a deeper scientific understanding of why a manufacturing process behaves the way it does.

What unites these six topics is a view of pharmaceutical development as a single, integrated science in which the particle, the formulation, the process, and the patient are inseparable. The January 2027 issue, shaped by guest editors Hwang, Kim, and Park, arrives at a moment when the industry faces an unusually demanding pipeline of biologics, poorly soluble small molecules, and personalized therapies, all of which strain conventional formulation methods. By soliciting work that moves from fundamental particle phenomena to Quality by Design frameworks and commercial-scale production, the Journal of Pharmaceutical Investigation is positioning the special issue as a status report on how the field converts molecular discovery into reliable, manufacturable medicine. Submissions are open until June 30, 2026, and the editors’ collective expertise across formulation technology, physical pharmacy, and drug delivery suggests the resulting collection will speak to academic researchers and industrial scientists alike, precisely the audience charged with making sure that the next generation of drug molecules does not fail for want of a suitable dosage form.

Subject of Research: A special issue of the Journal of Pharmaceutical Investigation on particle engineering and formulation science for pharmaceutical 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, bioavailability, solid-state characterization, quality by design, process analytical technology, pharmaceutical manufacturing, scale-up, dosage forms, solubility enhancement, Journal of Pharmaceutical Investigation