The central problem the special issue addresses is one of the oldest in pharmacology: most new drug candidates dissolve poorly in water, and therefore poorly in the human body. Industry estimates routinely suggest that a large majority of molecules entering development pipelines fall into the poorly soluble category, a phenomenon rooted in the increasingly lipophilic targets chosen by modern drug discovery. A molecule may bind its biological target with exquisite precision, yet if it cannot dissolve in gastrointestinal fluid or blood plasma, it will never reach that target at meaningful concentrations. Particle engineering attacks this bottleneck at its physical origin, reshaping crystals, particles, and surfaces so that dissolution kinetics, physical stability, and ultimately bioavailability are improved without altering the molecule’s chemical identity.

The techniques involved span an impressive range of physical chemistry. Micronization and nanonization reduce particle size to increase surface area available for dissolution, following the Noyes-Whitney relationship that links dissolution rate to interfacial area. Amorphous solid dispersion stabilizes a drug in a disordered, high-energy glassy state, trading thermodynamic stability for dramatically higher apparent solubility, and then relies on polymers to inhibit recrystallization during storage. Hot-melt extrusion, spray drying, and supercritical fluid processing each offer different routes to these engineered states, with distinct advantages in thermal stress, solvent residue, and scalability. Co-crystal engineering, meanwhile, adds a second molecular component to the crystal lattice itself, tuning solubility and mechanical properties through supramolecular design rather than chemical modification of the active ingredient.

Solid-state characterization forms the analytical backbone of all these approaches. A single active pharmaceutical ingredient can exist in multiple polymorphic forms, each with its own lattice energy, melting point, solubility, and tendency to transform over time. The infamous case of ritonavir, whose more stable and far less soluble polymorph emerged unexpectedly during manufacturing in the late 1990s and forced a market withdrawal, remains a cautionary tale taught to every formulation scientist. Modern development therefore deploys a battery of techniques, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, solid-state nuclear magnetic resonance, and Raman spectroscopy, to identify, quantify, and monitor solid forms throughout a product’s lifecycle. The special issue’s explicit focus on solid-state characterization and control reflects how central this discipline has become to regulatory acceptance and commercial reliability.

What distinguishes the current moment, and presumably the contributions the editors hope to attract, is the emphasis on translation. Moving a particle-engineered formulation from a bench-scale beaker to a commercial manufacturing line is notoriously difficult. A nanosuspension prepared by wet milling at laboratory scale may exhibit different particle size distributions, aggregation behavior, and dissolution profiles when produced in tonnes. Amorphous dispersions that remain stable for months in a sealed vial may crystallize under the humidity and mechanical stress of tableting. Scale-up science addresses these gaps through process modeling, careful control of drying rates and shear forces, and a deep understanding of how unit operations such as blending, granulation, and compression interact with engineered particle properties. Translational formulation science, as the special issue frames it, is the discipline of preserving laboratory-designed performance through every stage of industrial realization.

The scope of dosage forms under consideration is deliberately broad. Oral solid dosage forms remain the workhorse of pharmaceutical therapy, but the listed topics extend to injectable, inhalable, and transdermal delivery systems as well as advanced drug delivery platforms. Each route imposes its own particle requirements. Inhaled medicines demand aerodynamic particle sizes typically in the range of one to five micrometers to deposit in the deep lung, requiring exquisitely controlled crystallinity and surface properties for dry powder formulations. Injectable products must balance solubility enhancement against tolerability, sterility assurance, and the risk of particle-induced adverse effects. Transdermal systems depend on drug physicochemical properties, formulation vehicles, and permeation enhancement strategies working in concert. By covering this full spectrum, the issue acknowledges that particle engineering principles are universal even as their implementation is route-specific.

Manufacturing technology constitutes another pillar of the announced scope. Continuous manufacturing, in which raw materials flow through connected unit operations without batch interruptions, has gained regulatory momentum because it offers tighter process control, smaller footprints, and faster response to demand. Additive manufacturing, most visibly three-dimensional printing, enables dosage forms with complex internal geometries and personalized doses that conventional compression cannot achieve. These emerging technologies intersect directly with particle engineering: a continuously manufactured amorphous dispersion, for example, must be produced and downstream-processed within narrow residence-time windows to prevent degradation or phase transformation. The special issue’s inclusion of emerging manufacturing technologies signals an intent to bridge the gap between formulation design at the molecular scale and production realities at the industrial scale.

Quality by Design and Process Analytical Technology, listed among the topics, represent the regulatory and operational framework within which all of this science is now conducted. Quality by Design, codified in international guidelines, requires developers to understand and control the relationships between formulation variables, process parameters, and product quality attributes rather than merely testing finished batches. Process Analytical Technology supplies the real-time sensors, near-infrared spectroscopy, Raman probes, and inline particle size analyzers, that make such control feasible on the factory floor. Together they shift pharmaceutical development from an empirical, trial-and-error enterprise toward a predictive, model-driven one, in which design spaces are established statistically and manufacturing deviations are detected and corrected as they occur rather than discovered after the fact.

The guest editorial team brings complementary perspectives befitting this breadth. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research, Min-Soo Kim of Pusan National University works extensively on particle engineering and solubility enhancement technologies, and Heejun Park of Duksung Women’s University contributes expertise in formulation and physical pharmacy. Their call for contributions, open until the end of June 2026, invites researchers working across the interface of particle science, formulation design, manufacturing innovation, and translational development to submit their findings for the January 2027 issue. For a field whose advances often remain invisible to the public, buried inside the excipient lists and dissolution specifications of approved medicines, the special issue promises a consolidated snapshot of how the physical sciences of particles and formulations are being pushed from the laboratory bench toward the pharmacy shelf, one engineered particle at a time.

Subject of Research: Special Issue: Translational Advances in Pharmaceutical Dosage Form Development Based on 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: Special, Issue, Translational, Advances, Pharmaceutical, Dosage, Form, Development, Based, Particle, Engineering, Formulation