The premise underlying the special issue is deceptively simple. A drug molecule, no matter how elegant its biological mechanism, is therapeutically useless if it cannot be dissolved, absorbed, stabilized, and delivered at the right place and the right time. Industry analysts and regulatory reviewers alike have long noted that a large fraction of newly discovered drug candidates, particularly the poorly soluble small molecules that dominate modern discovery pipelines, fail not because of their pharmacology but because of their physical chemistry. Particle engineering and formulation science exist precisely to close that gap, and the special issue’s topic list reads as a map of the field’s current priorities.

The first of those priorities is the use of particle engineering approaches to enhance solubility, stability, and bioavailability. This encompasses a family of techniques that manipulate the solid state of a drug substance itself. Milling and micronization reduce particle size to increase surface area and accelerate dissolution. Nanosizing pushes that logic further, generating drug particles hundreds of nanometers across whose dramatically elevated surface-to-volume ratios can transform a practically insoluble compound into an orally absorbable one. Amorphous solid dispersion takes a different route, locking a crystalline drug into a glassy, higher-energy state stabilized by polymeric carriers, thereby creating a supersaturating formulation that drives absorption. Each of these strategies trades thermodynamic stability for kinetic advantage, and managing that trade-off is one of the central intellectual challenges of the discipline.

Closely related is the special issue’s emphasis on solid-state characterization and control. Crystalline drugs can exist in multiple polymorphic forms, each with a distinct crystal lattice and, consequently, distinct solubility, melting behavior, mechanical properties, and shelf-life stability. The notorious case of ritonavir, an HIV drug whose manufacturing process failed in 1998 when a previously unknown, far less soluble polymorph spontaneously appeared in production, remains a defining cautionary tale for the industry. Modern pharmaceutical development therefore deploys an arsenal of analytical techniques, including X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance, to identify, quantify, and monitor the solid forms present in a drug product. The goal is not merely to characterize a formulation at the moment of approval but to guarantee that the same solid state persists through years of storage, transport, and patient use.

The second major pillar of the special issue concerns advanced formulation strategies across the full spectrum of dosage routes: oral, injectable, inhalable, transdermal, and beyond. Each route imposes its own engineering constraints. Oral formulations must survive the acidic environment of the stomach and the enzymatic gauntlet of the gastrointestinal tract before releasing their payload. Injectable products must achieve sterility, isotonicity, and freedom from particulates while often stabilizing proteins or peptides that would denature under almost any provocation. Inhaled medicines demand particle sizes tightly clustered around one to five micrometers, the narrow window in which aerosolized droplets can navigate the airways and deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must persuade molecules to cross the stratum corneum, the skin’s remarkably effective lipid barrier, typically limiting passive delivery to small, moderately lipophilic compounds unless permeation enhancers, microneedles, or active driving forces are employed.

Advanced drug delivery systems extend these ambitions further. Lipid nanoparticles, which became household names through their role in mRNA vaccines against COVID-19, exemplify how particle engineering at the nanoscale can enable entirely new therapeutic modalities. Similar platforms, including polymeric nanoparticles, liposomes, amorphous nanosuspensions, and engineered crystal forms, are being adapted to protect fragile biologics, target drugs to specific tissues, and control release kinetics over hours, days, or even months. The special issue’s call for work on such systems signals an intent to bridge the classical literature on small-molecule dosage forms with the rapidly evolving science of delivery vehicles for nucleic acids, peptides, and cell therapies.

Translational formulation science and scale-up form the third thematic axis, and arguably the one with the greatest economic stakes. A formulation that performs brilliantly in a laboratory beaker is not a medicine until it can be manufactured reproducibly at industrial scale, in equipment that behaves differently from benchtop apparatus, under the time and cost pressures of commercial production. Wet granulation, hot-melt extrusion, spray drying, and roller compaction each involve process parameters, temperatures, feed rates, solvent ratios, drying profiles, that profoundly influence the final product’s critical quality attributes. Scale-up failures, in which a process validated at kilogram scale produces out-of-specification material at ton scale, remain a persistent source of development delays and regulatory filings. Translational formulation science seeks to anticipate these failures by understanding the underlying physics rather than relying on trial and error.

That ambition connects directly to the special issue’s final two topics: emerging manufacturing technologies and the application of Quality by Design and Process Analytical Technology, known respectively as QbD and PAT. QbD is a regulatory philosophy, formalized in guidance from the United States Food and Drug Administration and the International Council for Harmonisation, that shifts pharmaceutical development from end-product testing toward a deep, predictive understanding of how formulation composition and process parameters determine product quality. Under a QbD framework, developers define a quality target product profile, identify the critical quality attributes that matter to patients, and map the design space of process conditions within which those attributes are reliably achieved. PAT complements this by embedding real-time sensors, near-infrared spectroscopy, Raman spectroscopy, and laser diffraction among them, directly into manufacturing lines, allowing continuous monitoring and control rather than retrospective batch testing.

The convergence of QbD, PAT, and emerging manufacturing technologies is reshaping what a pharmaceutical factory looks like. Continuous manufacturing, in which raw materials flow through linked unit operations to emerge as finished drug product without batch-wise interruption, is steadily displacing traditional batch processing for suitable products. Additive manufacturing, including three-dimensional printing of tablets with tailored internal geometries, has already produced a commercially approved, rapidly disintegrating epilepsy medication and promises personalized dosing in the future. Artificial intelligence and machine learning models are increasingly used to predict formulation stability, optimize process settings, and reduce the number of physical experiments required during development. The special issue’s inclusion of these topics reflects a consensus that the next decade of dosage form development will be defined as much by digitalization and process engineering as by chemistry.

For researchers, the June 30, 2026 submission deadline frames the special issue as a snapshot of a discipline in transition. The guest editors’ institutional affiliations, spanning Yonsei, Pusan National, and Duksung Women’s Universities, situate the effort within South Korea’s substantial pharmaceutical sciences community, though the topics are global in scope and the journal’s readership international. What emerges from the issue, if the field’s trajectory holds, will be a body of work demonstrating that the humble pill, injection, inhaler, and patch are not commodity afterthoughts to drug discovery but sophisticated engineered systems in their own right. The molecule may capture the headline, but it is particle engineering and formulation science that determine whether that molecule ever reaches a patient, dissolves at the right moment, survives the journey, and does so reliably for every dose of every batch for the life of the product.

Subject of Research: Translational pharmaceutical dosage form development using 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

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, nanoparticles, scale-up, pharmaceutical manufacturing, dosage forms