The central challenge the special issue addresses is deceptively simple to state and extraordinarily difficult to solve. An estimated large fraction of newly discovered drug candidates, particularly the small molecules emerging from high-throughput screening campaigns, are poorly soluble in water. A molecule may bind its biological target with exquisite precision in a test tube, yet if it cannot dissolve in the fluids of the gastrointestinal tract or in the bloodstream, it will never reach therapeutic concentrations in the body. This is where particle engineering enters the picture. By manipulating the size, shape, crystal form, and surface properties of drug particles down to the nanometer scale, scientists can dramatically alter how a compound dissolves, how stable it remains on the shelf, and how much of it ultimately becomes available to the body, a property known as bioavailability.

The guest editors steering the issue bring complementary expertise to this agenda. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery systems, Min-Soo Kim of Pusan National University is known for work on particle engineering and solid-state pharmaceutics, and Heejun Park of Duksung Women’s University contributes depth in formulation science and dosage form development. Their combined vision, as reflected in the topics outlined for the issue, is explicitly translational: the emphasis is not merely on elegant laboratory demonstrations but on approaches that can survive the journey from bench to manufacturing line to patient, a journey that defeats a large proportion of otherwise promising formulation strategies every year.

Among the six thematic pillars of the call for papers, the first concerns particle engineering approaches for enhancing solubility, stability, and bioavailability. This encompasses a suite of technologies that have matured considerably over the past two decades. Nanocrystal suspensions, in which drug particles are reduced to sizes below a few hundred nanometers, exploit the fact that dissolution rate increases as particle size decreases, following classical Noyes-Whitney relationships. Amorphous solid dispersions take a different route, locking a drug molecule in a disordered, high-energy glassy state rather than its thermodynamically stable crystalline form, thereby achieving apparent solubility gains that can be orders of magnitude greater than the crystalline reference. Each strategy carries trade-offs: amorphous materials risk recrystallization during storage, while nanocrystals demand careful control of agglomeration, and the special issue is expected to showcase advances in managing precisely these vulnerabilities.

A second pillar covers advanced formulation strategies across the full spectrum of dosage routes, including oral, injectable, inhalable, and transdermal delivery, alongside broader advanced drug delivery systems. The significance of this breadth is hard to overstate. Oral solid dosage forms such as tablets and capsules still dominate the pharmaceutical market, but biologics, peptides, and RNA-based therapeutics are forcing the industry to rethink delivery entirely. Injectable long-acting formulations can sustain drug release for weeks or months from a single depot, transforming treatment adherence in conditions ranging from schizophrenia to HIV. Inhalable powders deliver drugs directly to the lung with particle size distributions engineered to deposit in specific airway regions, while transdermal systems bypass first-pass metabolism through the skin. Each route imposes its own particle-level requirements, from aerodynamic diameter in inhalation to needle-free injectability of suspensions, and formulation science sits at the intersection of all of them.

The third thematic area, solid-state characterization and control, addresses a subtler but equally critical dimension of drug development. Many drug molecules can exist in multiple crystalline forms, known as polymorphs, which differ in the packing arrangement of their molecules and consequently in their melting point, solubility, dissolution behavior, and mechanical properties. The regulatory and commercial stakes are enormous: a single unintended polymorph conversion can compromise a product’s performance or even trigger withdrawal from the market, a lesson etched into industry history by high-profile cases involving antiretroviral and antiulcer drugs. Modern characterization tools, including powder X-ray diffraction, differential scanning calorimetry, solid-state nuclear magnetic resonance, and vibrational spectroscopy, allow scientists to identify and monitor these forms with increasing precision, and the special issue will highlight how such analytical control is being embedded into development workflows rather than bolted on afterward.

Perhaps the most distinctive feature of the issue’s scope is its insistence on translational formulation science and scale-up. The pharmaceutical industry has long suffered from what researchers informally describe as the valley of death between formulation research and commercial manufacture: a nanosuspension that performs beautifully at the milliliter scale in a university laboratory may prove impossible to reproduce at the thousand-liter scale of a production facility, where mixing dynamics, heat transfer, and drying behavior behave entirely differently. Technologies such as hot-melt extrusion, spray drying, and high-pressure homogenization must be understood not just as laboratory tools but as industrial unit operations with their own engineering constraints. Contributions addressing how formulation designs survive this transition, how critical quality attributes are preserved during scale-up, and how development timelines can be compressed without sacrificing rigor are expected to form a core of the published collection.

Emerging manufacturing technologies constitute the fifth pillar, and this is where the field’s momentum is most visible. Continuous manufacturing, which replaces the traditional batch-based model with a steady flow of material through interconnected unit operations, is gaining regulatory acceptance and offers real-time quality control, smaller facility footprints, and faster response to demand. Additive manufacturing, including various forms of three-dimensional printing, opens the possibility of dosage forms with complex internal geometries tailored to release profiles that conventional compression cannot achieve, and in principle enables on-demand production of personalized doses. Alongside these, advances in microfluidic nanoparticle production and electrospinning are expanding the toolbox available to formulators. The special issue’s inclusion of commercial production among its interests signals that the editors want papers demonstrating not just feasibility but manufacturability.

The final thematic strand, Quality by Design and Process Analytical Technology, represents the intellectual framework that binds the others together. Quality by Design, or QbD, is a regulatory philosophy, codified in international guidance, that requires manufacturers to understand and control the relationships between formulation ingredients, process parameters, and product quality, rather than simply testing finished products and hoping for the best. Process Analytical Technology, or PAT, supplies the instruments that make this possible in practice: inline and online sensors such as near-infrared and Raman spectroscopy that monitor critical attributes in real time during manufacturing, feeding data into control systems that can adjust parameters on the fly. Together, QbD and PAT shift pharmaceutical development from an empirical, trial-and-error discipline toward a predictive, science-based engineering practice, and their application to particle engineering processes is an area of intense current research.

For the broader scientific community, the significance of this special issue lies in its timing and its framing. The pharmaceutical pipeline is increasingly dominated by molecules and modalities that stress every assumption of classical dosage form design: poorly soluble small molecules, large fragile biologics, nucleic acid therapeutics requiring lipid nanoparticles, and combination products that blur the line between drug and device. Meanwhile, regulators and health systems are demanding shorter development times, more robust supply chains, and dosage forms that improve patient adherence. Particle engineering and formulation science sit squarely at the confluence of these pressures, and the January 2027 issue of the Journal of Pharmaceutical Investigation, with submissions due by June 30, 2026, is positioned to become a landmark snapshot of how the discipline is converting laboratory insight into medicines that patients can actually benefit from. Researchers working across solubility enhancement, solid-state science, manufacturing innovation, and quality systems now have a clearly defined venue to present that translational story in full.

Subject of Research: Translational pharmaceutical formulation 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

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, bioavailability, solid-state characterization, polymorphism, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, Journal of Pharmaceutical Investigation