The central problem the special issue addresses is one of the oldest in pharmacology: many promising drug molecules simply do not dissolve well enough in the human body to be effective. It is estimated that a large fraction of newly discovered active pharmaceutical ingredients, particularly those emerging from high-throughput screening pipelines, are poorly water-soluble. A molecule can be extraordinarily potent against its biological target in vitro, yet if it cannot dissolve in gastrointestinal fluids or blood plasma, it will never reach therapeutic concentrations in a patient. Particle engineering offers a family of solutions to this dilemma. By manipulating crystal form, particle size, surface properties, and morphology, formulation scientists can dramatically alter how a drug dissolves, how stable it remains on the shelf, and how much of it ultimately becomes bioavailable to the patient.

Among the most powerful of these techniques is micronization and, at the extreme end, nanonization, in which drug crystals are reduced to particles measured in hundreds of nanometers or less. According to the Noyes-Whitney equation, a foundational relationship in dissolution science, the rate at which a particle dissolves is proportional to its surface area. Shrinking a particle’s diameter by a factor of ten increases its surface-area-to-volume ratio dramatically, accelerating dissolution and, in the case of nanocrystals, raising the apparent solubility through curvature-dependent effects described by the Ostwald-Freundlich relationship. Technologies such as wet media milling, high-pressure homogenization, and supercritical fluid processing have matured from academic curiosities into industrial workhorses, and several nanocrystal-based products have reached the market. The special issue explicitly invites contributions on particle engineering approaches for solubility, stability, and bioavailability enhancement, a scope that encompasses these techniques and the analytical methods needed to keep them under control.

Equally important is the solid state of the drug itself. The same molecule can crystallize into multiple polymorphic forms, each with a distinct lattice arrangement and, consequently, distinct thermodynamic properties. A metastable polymorph may dissolve faster and deliver better bioavailability, but it risks converting to the more stable, less soluble form during storage, a transformation that can silently erode a product’s performance. Amorphous solid dispersions take this logic further by locking the drug in a disordered, glassy state stabilized within a polymer matrix, sacrificing thermodynamic stability for a substantial solubility advantage. The challenge, and a core theme of translational formulation science, is characterizing and controlling these states rigorously. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to fingerprint the solid form and detect the earliest signs of physical change, ensuring that what is tested in the clinic is what patients eventually receive.

The scope of the special issue extends well beyond oral tablets and capsules. The editors have called for advanced formulation strategies across oral, injectable, inhalable, and transdermal routes, along with broader advanced drug delivery systems. Each route imposes its own engineering constraints. Inhaled medicines, for example, demand particles in a narrow aerodynamic diameter range, typically between one and five micrometers, so that they can navigate the branching airways and deposit deep in the lungs rather than being exhaled or trapped in the throat. Transdermal systems must balance drug solubility in an adhesive matrix against the permeability barrier of the stratum corneum, the outermost layer of skin. Injectable formulations face stringent requirements for sterility, isotonicity, and the absence of particulate contamination, and increasingly involve complex biologics whose three-dimensional structures are fragile and easily degraded. Formulation science in each of these domains has developed specialized particle and materials technologies, and the special issue aims to capture advances across this full spectrum.

What distinguishes this particular call for papers is its emphasis on translation and scale-up. It is one thing to prepare an elegant nanosuspension in a laboratory beaker; it is another to reproduce that same particle size distribution, dissolution profile, and stability at a scale of thousands of liters in a regulated manufacturing facility. Scale-up introduces complications that rarely appear in small-scale experiments: differences in mixing dynamics, heat transfer, shear forces, and equipment geometry can all alter the final product. Continuous manufacturing, in which drug product is produced in a flowing process rather than discrete batches, has emerged as a promising answer, offering tighter process control, smaller equipment footprints, and real-time quality monitoring. Hot-melt extrusion, spray drying, and continuous granulation are among the technologies that have moved from pilot plants into commercial production, and the special issue’s focus on emerging manufacturing technologies in dosage form design and commercial production reflects how central these approaches have become to the industry’s future.

Underpinning much of this progress is a regulatory and methodological framework known as Quality by Design, or QbD, paired with Process Analytical Technology, or PAT. Rather than testing finished products to catch defects after the fact, QbD asks developers to build quality into the product from the start: to identify the critical quality attributes that determine performance, understand which process parameters and material properties influence them, and establish a design space within which the product reliably meets its specifications. PAT supplies the sensory apparatus for this philosophy, embedding inline and online instruments such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement directly into manufacturing equipment. These tools provide continuous streams of data on blend uniformity, particle size, moisture content, and polymorphic identity, allowing operators to detect and correct drift in real time. The special issue’s explicit inclusion of QbD and PAT applications in pharmaceutical formulation and manufacturing underscores how thoroughly this paradigm has reshaped the discipline, turning formulation development from an empirical craft into a quantitative engineering science.

The translational framing also carries significance for the economics and pace of drug development. Formulation failures late in development are costly: a candidate that performs well in early-phase trials but cannot be manufactured consistently, or whose stability profile collapses in humid climates, can stall or sink an otherwise promising program. By integrating particle engineering, solid-state control, and QbD principles from the earliest stages, developers aim to de-risk the path from molecule to medicine. This is particularly urgent as the industry’s pipeline shifts toward challenging modalities, including poorly soluble small molecules, high-molecular-weight biologics, peptides, and emerging formats such as drug-device combinations and long-acting injectables that release medication over weeks or months. Each of these pushes the boundaries of conventional dosage form design and rewards laboratories that can move fluidly between fundamental materials characterization and practical process engineering.

The Korean formulation science community hosting the issue has been an active contributor to these fields, with research groups at Yonsei University, Pusan National University, and Duksung Women’s University publishing extensively on topics ranging from amorphous formulations and nanocrystal technology to pediatric and geriatric dosage forms and advanced delivery platforms. Guest editor leadership of this kind typically brings a coherent scientific vision to a special issue, and the editors’ combined expertise in pharmaceutics, particle technology, and translational development suggests the collection will emphasize work that is not merely novel in a journal sense but genuinely positioned for industrial application. Researchers worldwide working on solubility enhancement, solid-state science, continuous manufacturing, and process analytics now have a defined venue and a June 30, 2026 deadline for submitting their findings.

For readers outside the field, the significance of this special issue lies in a quiet revolution. The medicines that patients take are not just molecules; they are carefully engineered systems in which every crystal form, particle size, excipient choice, and process parameter has been deliberately selected and validated. The coming years will likely see these systems become still more sophisticated, driven by computational modeling of formulation behavior, machine-learning-guided formulation screening, and manufacturing lines that adjust themselves in response to real-time analytical data. By dedicating an entire issue to translational advances in particle engineering and formulation science, the Journal of Pharmaceutical Investigation is spotlighting the discipline that turns chemical potential into clinical reality, and inviting the global research community to document how laboratory insight becomes a dosage form that can be manufactured, regulated, and trusted by millions of patients.

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

DOI: Not provided

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