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

A major pharmaceutical science journal has opened the door to one of the most consequential conversations in modern drug development. The Journal of Pharmaceutical Investigation, published by Springer, 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. 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 will gather research spanning the full journey of a medicine, from the microscopic architecture of drug particles to the industrial processes that turn them into medicines patients can actually take. With a submission deadline of June 30, 2026, the editors are inviting contributions that do more than describe laboratory curiosities; they want work that demonstrably moves toward the clinic and the manufacturing floor.

The timing of this special issue reflects a quiet crisis at the heart of modern pharmacology. An ever-growing share of new drug candidates emerging from discovery pipelines are poorly soluble in water, a property that can render even the most biologically potent molecule therapeutically useless. When a drug cannot dissolve in the gastrointestinal tract, it cannot be absorbed into the bloodstream, and bioavailability, the fraction of the administered dose that actually reaches circulation, collapses. Particle engineering has become the discipline’s primary counterattack. By reducing particle size to the micrometer and nanometer scale, scientists dramatically increase the surface area available for dissolution, and by manipulating crystal forms, amorphous states, and surface properties, they can stabilize formulations that would otherwise revert to less soluble configurations. The special issue explicitly calls for work on particle engineering approaches that enhance solubility, stability, and bioavailability, signaling that these foundational questions remain far from solved.

One of the most technically rich areas the issue will address is solid-state characterization and control. A single drug molecule can exist in multiple crystalline forms, known as polymorphs, each with distinct physical properties, dissolution behavior, and stability profiles. The notorious case of ritonavir, an HIV drug that spontaneously converted to a previously unknown, far less soluble polymorph in the late 1990s and forced a market withdrawal, remains a cautionary tale taught to every formulation scientist. Hydrates, solvates, salts, cocrystals, and amorphous solid dispersions each add further complexity. Modern characterization tools, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance, allow researchers to fingerprint these states with extraordinary precision. Yet the challenge is not merely identifying a form in the laboratory; it is guaranteeing that the same form persists through granulation, drying, tableting, coating, storage in humid climates, and the patient’s own stomach. Contributions that demonstrate robust control over solid-state transformations across this entire chain are precisely what the editors hope to attract.

The scope of dosage forms under consideration is deliberately broad, encompassing oral, injectable, inhalable, and transdermal routes alongside advanced drug delivery systems. Each route imposes its own particle-level demands. Inhaled medicines, for example, require particles in a narrow aerodynamic diameter range, typically between one and five micrometers, to deposit in the deep lung rather than being exhaled or trapped in the throat. Dry powder inhalers therefore depend on engineering particles with the right size, shape, and interparticle forces to flow through a device and disperse into a respirable aerosol. Injectable formulations face constraints on osmolality, viscosity, and sterility, and increasingly rely on nanosuspensions or lipid-based carriers to deliver poorly soluble compounds. Transdermal systems must coax molecules across the skin’s formidable barrier, often using particle-based adhesives or microneedle architectures. By treating these routes together, the special issue underscores a unifying idea: the same principles of particle design and formulation science govern success regardless of where in the body the drug must end up.

Perhaps the most distinctive emphasis of the call is translational formulation science and the scale-up of drug products. The gap between an elegant formulation in a research laboratory and a commercially manufacturable medicine is wide and littered with failures. A nanosuspension produced in small batches by high-pressure homogenization may behave entirely differently when produced at industrial scale, where shear rates, heat transfer, and residence time distributions change fundamentally. Wet granulation processes that yield uniform granules in a kilogram-scale mixer can produce inconsistent blends in a multi-hundred-kilogram vessel. Translational science in this context means systematically understanding how material attributes and process parameters interact, so that a formulation designed in early development survives the journey through clinical trial supplies, regulatory filing, and commercial production. The editors’ decision to foreground scale-up acknowledges that many scientifically impressive delivery technologies have stalled not because they failed to work, but because they could not be made reliably, affordably, and reproducibly at scale.

Emerging manufacturing technologies form another pillar of the issue. Continuous manufacturing, in which drug substance and excipients flow through connected unit operations rather than being processed in discrete batches, is reshaping the industry’s approach to production. Coupled with process analytical technology, or PAT, continuous lines allow real-time monitoring of critical quality attributes such as blend uniformity, particle size distribution, and moisture content, enabling immediate feedback control rather than end-of-line testing. Additive manufacturing, best known through the first FDA-approved 3D-printed tablet, offers the possibility of dosage forms with intricate internal geometries that control release kinetics in ways conventional compression cannot achieve. Hot-melt extrusion, spray drying, supercritical fluid technologies, and nanoformation techniques such as wet milling and microfluidic precipitation each provide distinct routes to engineered particles and amorphous systems. Research demonstrating how these technologies translate into dosage forms that meet regulatory expectations will find a natural home in the special issue.

Woven through the entire call is the framework of Quality by Design, universally abbreviated as QbD, together with its operational companion, PAT. Quality by Design inverts the traditional approach to pharmaceutical development. Rather than testing finished products to catch defects, QbD demands that developers first identify the quality attributes that matter to patients, then determine the formulation variables and process parameters that control those attributes, and finally build a design space within which the product is guaranteed to meet specifications. This risk-based, science-driven philosophy, embedded in international regulatory guidance, has transformed how drug companies interact with agencies such as the FDA and EMA. PAT instruments, including near-infrared spectroscopy, Raman spectroscopy, and laser diffraction probes mounted directly on processing equipment, supply the real-time data that make QbD operational. Contributions showing how these frameworks accelerate formulation development, reduce development timelines, and support regulatory submissions will be central to the issue’s translational mission.

The guest editorial team itself signals the issue’s breadth and credibility. Sung-Joo Hwang of Yonsei University has long been associated with pharmaceutical formulation and drug delivery research in Korea, while Min-Soo Kim of Pusan National University is known for work on particle engineering and pharmaceutical manufacturing technologies, and Heejun Park of Duksung Women’s University brings expertise in formulation science. Their combined perspective spans the academic, translational, and industrial dimensions that the special issue is designed to bridge. The Journal of Pharmaceutical Investigation, as a publication of the Korean Pharmaceutical Association’s investigative community, has historically served as an international venue for pharmaceutics research connecting Asian and global drug development communities, and this issue is positioned to consolidate that role at a moment when formulation science is gaining strategic importance worldwide.

Why should a general audience care about the seemingly arcane world of particle engineering? Because it sits at the bottleneck of nearly every new medicine. Billions of dollars invested in discovering molecular targets and designing potent compounds can be wasted if those compounds cannot be formulated into stable, absorbable, manufacturable products. The rise of biologics, the repurposing of old drugs with poor solubility, and the demand for patient-friendly formats such as long-acting injectables and orally disintegrating tablets all depend on advances in this field. The COVID-19 pandemic offered a vivid demonstration, as oral antivirals with challenging solubility profiles had to be formulated, characterized, and scaled to billions of doses under extraordinary time pressure. The special issue’s January 2027 publication date will arrive as the industry continues to digest those lessons.

For researchers, the June 30, 2026 deadline establishes a clear runway for submitting work on solubility enhancement, advanced delivery systems, solid-state control, scale-up science, emerging manufacturing, and QbD applications. For the broader scientific public, the issue promises a snapshot of how the medicines of the coming decade will be designed, not merely discovered. The transformation of a molecule into a medicine is one of the least visible yet most decisive steps in healthcare, and by dedicating an entire issue to its translational dimensions, the Journal of Pharmaceutical Investigation is betting that particle engineering and formulation science will define the next frontier of pharmaceutical innovation.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for 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, continuous manufacturing, scale-up, pharmaceutical dosage forms, solubility enhancement, Journal of Pharmaceutical Investigation