The premise behind the issue is deceptively simple. A drug molecule, no matter how elegant its biological mechanism, is useless if it cannot be dissolved, absorbed, stabilized, manufactured, and delivered at a consistent dose. Industry analysts have long estimated that a large fraction of new chemical entities emerging from discovery pipelines fall into the Biopharmaceutics Classification System classes II and IV, meaning they are poorly soluble in water and therefore poorly absorbed in the gastrointestinal tract. Particle engineering exists precisely to close that gap between a molecule’s pharmacological promise and its clinical performance, and the special issue explicitly invites contributions on particle engineering approaches for solubility, stability, and bioavailability enhancement.

The technical toolkit in this field is broad and rapidly evolving. Micronization and nanonization reduce particle size to increase the surface area available for dissolution, following the Noyes-Whitney relationship that links dissolution rate to surface area and the concentration gradient at the particle interface. Nanocrystal stabilization requires careful selection of surfactants and polymeric stabilizers that prevent the Ostwald ripening and agglomeration that would otherwise erase the size advantage. Amorphous solid dispersions take a different route, locking a crystalline drug into a high-energy glassy state within a polymer matrix, trading thermodynamic stability for a supersaturation window that can dramatically improve oral absorption. Each strategy carries its own failure modes: amorphous systems can recrystallize on storage, nanosuspensions can sediment or aggregate, and lipid-based formulations can precipitate the drug prematurely in the gut. The special issue’s emphasis on solid-state characterization and control speaks directly to these challenges.

Solid-state science has become one of the quiet revolutions of pharmaceutical development. Polymorphism, the ability of a molecule to crystallize in multiple packing arrangements, can change solubility, dissolution rate, mechanical properties, and even chemical stability. Regulatory agencies worldwide require rigorous characterization of the solid form selected for development, and a single unanticipated polymorph discovered late in development can derail a product. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance now allow formulators to map the landscape of possible forms, including hydrates, solvates, salts, and cocrystals. Cocrystallization in particular has opened a regulatory-recognized path to modifying physicochemical properties without altering the covalent structure of the active ingredient, and contributions on such strategies fall squarely within the issue’s scope.

The scope of the special issue extends well beyond oral tablets and capsules. The editors explicitly welcome advanced formulation strategies for injectable, inhalable, transdermal, and other dosage forms, as well as advanced drug delivery systems. Each route imposes its own particle-level demands. Inhaled medicines, for example, must deposit particles in the deep lung, which generally requires aerodynamic diameters in the range of roughly one to five micrometers; engineered particles for dry powder inhalers must balance flowability for dose uniformity with dispersibility for lung deposition, often through carrier-based systems or particle coating technologies. Injectable long-acting formulations rely on controlled particle size and morphology to govern release kinetics over weeks or months. Transdermal systems must navigate the stratum corneum, the skin’s formidable barrier, using chemical enhancers, microneedle arrays, or drug-in-adhesive designs. The breadth of the call reflects a recognition that particle and formulation science is a unifying discipline across all of drug delivery.

Perhaps the most distinctive element of the issue’s framing is the word translational. Laboratory-scale breakthroughs in formulation are notoriously difficult to carry into commercial manufacturing. A nanosuspension prepared by wet milling in a one-liter vessel may behave very differently when produced at thousands of liters, where milling time, media wear, heat transfer, and mixing efficiency all change. Spray drying, hot-melt extrusion, and supercritical fluid technologies each present their own scale-up puzzles. The call for papers on translational formulation science and scale-up of drug products, and on emerging manufacturing technologies in dosage form design and commercial production, signals an intent to publish work that bridges the gap between the bench and the production line, a gap that has historically consumed years and hundreds of millions of dollars in development programs.

Two acronyms in the call for papers, QbD and PAT, describe the regulatory and analytical machinery that makes such translation possible. Quality by Design is a development philosophy, formalized in guidance from the United States Food and Drug Administration and the International Council for Harmonisation, that requires manufacturers to understand and control the relationships between formulation variables, process parameters, and product quality, rather than merely testing finished batches. Process Analytical Technology complements this by embedding real-time sensors, such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement, directly into manufacturing equipment, allowing continuous monitoring of particle size distribution, blend uniformity, and moisture content as production proceeds. Together they underpin the shift toward continuous manufacturing, in which tablets or other dosage forms are produced in a seamless flow rather than in discrete batch steps, with the potential for real-time release testing and dramatically shorter production footprints.

The timing of the issue is significant. The pharmaceutical industry is contending with a wave of increasingly difficult molecules: poorly soluble small molecules, high-molecular-weight biologics, peptides, and oligonucleotides that resist conventional delivery. At the same time, the expiration of patents on blockbuster drugs has intensified interest in value-added reformulations, in which particle engineering can extend product life cycles by improving convenience, tolerability, or bioavailability. The rise of artificial intelligence and machine learning in formulation design, including predictive models for excipient compatibility and process outcomes, adds another layer of momentum. A special issue that gathers peer-reviewed advances across solubility enhancement, solid-state control, manufacturing technology, and quality systems arrives at a moment when the discipline is being asked to deliver more, faster, and with greater regulatory scrutiny than ever before.

For researchers considering submission, the June 30, 2026 deadline places the issue roughly a year and a half from its announcement, a timeline consistent with the peer review and production cycles of a Springer journal serving the pharmaceutical sciences community. The Journal of Pharmaceutical Investigation, published by Springer, has historically served as a venue for research spanning drug delivery, physical pharmacy, and pharmaceutical technology, with a strong base in Asia and a growing international readership. The guest editors, based at Yonsei University, Pusan National University, and Duksung Women’s University, represent institutions with active programs in formulation science and drug delivery, and their editorial stewardship suggests the issue will emphasize work with clear relevance to product development rather than purely theoretical studies.

For the broader public, the significance of this research is easy to state: it is the difference between a molecule that works in a test tube and a medicine that works in a person. Every improved inhaler, every long-acting injection that frees a patient from daily pills, every pediatric formulation that a child can actually tolerate, rests on the kind of particle-level and process-level science that this special issue will collect and disseminate. As drug candidates grow more challenging and manufacturing grows more sophisticated, the translational pipeline from particle engineering to dosage form design will only grow in importance, and the January 2027 issue of the Journal of Pharmaceutical Investigation is positioned to document exactly how that pipeline is evolving.

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, amorphous solid dispersions, nanocrystals, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, Journal of Pharmaceutical Investigation