Three guest editors based in South Korea will steer the issue: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. All three are active researchers in pharmaceutics and drug delivery, and their combined expertise spans the design of dosage forms, the engineering of drug particles, and the translation of laboratory formulations into manufacturable drug products. Their editorial leadership reflects the journal’s positioning at the intersection of academic formulation science and industrial pharmaceutical development, a space where ideas must survive not only biological testing but also the realities of scale-up, regulatory scrutiny, and commercial production.

The scope of the call is deliberately broad, covering particle engineering approaches for enhancing solubility, stability, and bioavailability. This trio of properties sits at the heart of a persistent problem in drug development: a large proportion of newly discovered active pharmaceutical ingredients are poorly soluble in water, which limits how much of the drug can be absorbed into the bloodstream after oral administration. Particle engineering attacks the problem at its physical root. By reducing particle size to the micrometer or even nanometer scale, formulators dramatically increase the surface area available for dissolution, allowing poorly soluble drugs to dissolve faster and more completely in the gastrointestinal tract. Techniques such as wet milling, high-pressure homogenization, spray drying, and supercritical fluid processing are among the industrial workhorses used to achieve these size reductions in a controlled and reproducible way.

But particle engineering is not only about making particles smaller. It is equally about controlling the solid state of the drug itself. Many pharmaceutical compounds can exist in multiple crystalline forms, known as polymorphs, as well as in amorphous, non-crystalline states. Each form carries a distinct free energy, and that energy difference translates directly into different dissolution rates, different physical stabilities, and different tendencies to convert from one form to another over a product’s shelf life. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer matrix, can generate dramatic solubility improvements, yet they carry the risk of recrystallization during storage. The special issue’s explicit attention to solid-state characterization and control acknowledges that understanding and managing these transformations, using tools such as X-ray powder diffraction, differential scanning calorimetry, and spectroscopic methods, is essential to delivering formulations that remain stable from factory to pharmacy.

A second major theme of the call is advanced formulation strategies across the full spectrum of dosage routes: oral, injectable, inhalable, transdermal, and beyond, together with advanced drug delivery systems. Each route imposes its own demanding constraints. Oral solid dosage forms must survive manufacturing stresses such as compression and coating while releasing the drug at the right site and rate in the body. Injectable formulations must be sterile, isotonic, and free of particles that could trigger adverse reactions, and increasingly they must stabilize delicate biologics such as proteins and peptides that denature under thermal or interfacial stress. Inhalable products require particles engineered to an aerodynamic diameter typically between one and five micrometers so they can deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push drugs across the skin’s formidable barrier layer at therapeutic rates. The breadth of this topic area invites contributions that show how particle and formulation design principles adapt to these very different delivery challenges.

Perhaps the most distinctive emphasis of the special issue, and the one captured in its title, is translation. The editors are calling for work on translational formulation science and the scale-up of drug products, a stage of development where many promising laboratory formulations falter. A process that works beautifully at the gram scale in a research lab may behave very differently in a kilogram-scale manufacturing run, where mixing efficiency, heat transfer, drying kinetics, and equipment geometry all change. Spray drying a nanosuspension on a laboratory benchtop is a fundamentally different operation from running a commercial-scale dryer for hours at a time. Translational formulation science seeks to understand these shifts in advance, building formulations and processes that are robust by design rather than rescued through trial and error after scale-up failures occur.

Closely tied to this translational theme is the call’s inclusion of emerging manufacturing technologies in dosage form design and commercial production. Continuous manufacturing, in which drug product is produced in an uninterrupted flow rather than in discrete batches, has gained significant regulatory and industrial momentum because it offers tighter process control, smaller facility footprints, and faster response to demand changes. Additive manufacturing, including various three-dimensional printing approaches, opens the possibility of dosage forms with complex internal geometries and, in principle, personalized doses tailored to individual patients. Hot-melt extrusion, which combines mixing, melting, and shaping in a single continuous operation, has become a standard industrial method for producing amorphous solid dispersions of poorly soluble drugs. Contributions describing how such technologies reshape what is possible in dosage form design are squarely within the issue’s scope.

The final pillar of the call is the application of Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, to pharmaceutical formulation and manufacturing. QbD is a regulatory philosophy, formalized in international guidelines, that asks developers to build quality into a product from the start rather than testing it in at the end. In practice this means systematically identifying the critical material attributes of ingredients and the critical process parameters of manufacturing, then demonstrating how they relate to the quality attributes the patient ultimately experiences. PAT supplies the real-time measurement tools that make this vision workable: near-infrared spectroscopy probes that monitor blend uniformity inside a mixer, Raman sensors that track the solid form of a drug during drying, and feedback control systems that adjust process conditions the moment a deviation appears. Together, QbD and PAT transform formulation development from an empirical craft into a predictive, science-based engineering discipline.

For researchers working in these areas, the timeline offers a clear runway. Manuscripts are due by June 30, 2026, giving teams roughly a year and a half from the announcement to complete studies, and the issue itself is slated for January 2027. The topics list functions as a map of where the field sees its own frontier: solubility and bioavailability enhancement through particle design, advanced delivery systems across every major route, solid-state control, scale-up science, novel manufacturing, and quality-driven process development. Contributions that bridge basic science and commercial reality, showing not just that a formulation works in the laboratory but that it can be made reliably, characterized rigorously, and produced at scale, are likely to define the collection.

The announcement also underscores a broader shift in how the pharmaceutical sciences understand their own role. The era in which a drug molecule alone determined therapeutic success is giving way to one in which the dosage form is recognized as an engineered system in its own right, one whose particle properties, solid-state architecture, and manufacturing history are as consequential as the molecule it carries. By dedicating a full special issue to particle engineering and formulation science, and by framing it explicitly around translation, the Journal of Pharmaceutical Investigation and its guest editors are staking out the position that the path from molecule to medicine runs directly through this discipline, and that the tools now available, from nanoscale particle design to real-time process analytics, are finally mature enough to make that path faster, more predictable, and more scientifically grounded than ever before.

Subject of Research: A special issue call for research on particle engineering and formulation science in pharmaceutical 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, amorphous solid dispersions, scale-up, dosage forms, Journal of Pharmaceutical Investigation