The central problem the special issue addresses is deceptively simple to state and notoriously difficult to solve. An estimated large fraction of drug candidates emerging from discovery pipelines suffer from poor aqueous solubility, which means the molecules dissolve so slowly or incompletely in the gastrointestinal tract that they never reach therapeutic concentrations in the bloodstream. A molecule can be exquisitely potent against its biological target in a laboratory assay and still fail in the clinic simply because the body cannot absorb it. Particle engineering attacks this bottleneck at the physical level, manipulating crystal form, particle size, surface properties, and morphology to change how a drug dissolves. Reducing particle diameter increases the surface-area-to-volume ratio available for dissolution, while converting a crystalline solid to its amorphous state can dramatically raise the apparent solubility because the disordered lattice carries a higher free energy than its ordered counterpart.

The first listed topic of the call, particle engineering approaches for solubility, stability, and bioavailability enhancement, signals that the editors want submissions spanning the full toolbox of these techniques. That toolbox includes micronization and nanonization by wet milling or high-pressure homogenization, spray drying to produce amorphous solid dispersions in which drug molecules are molecularly dispersed within a polymeric carrier, supercritical fluid processing, and controlled crystallization methods that select for the most advantageous polymorphic form. Each technique involves a fundamental trade-off. Amorphous materials gain solubility but tend to recrystallize during storage, undermining shelf life. Nanoparticles dissolve faster but present challenges in stabilization, filtration, and downstream processing. The translational question, which runs through every topic in the special issue, is not whether a technique works on a laboratory bench but whether it survives the rigors of scale-up, regulatory scrutiny, and long-term storage.

Solid-state characterization and control form the third pillar of the announced scope, and this is where the physics of pharmaceutical materials becomes genuinely intricate. A single drug molecule can crystallize in multiple polymorphic forms, each with a distinct arrangement of molecules in the crystal lattice and, consequently, distinct melting points, dissolution rates, and stability profiles. The classic cautionary tale in the field involves polymorphic transitions occurring after a product reaches the market, forcing reformulation or withdrawal. Regulators therefore require manufacturers to identify and control the solid-state form of the active ingredient throughout a product’s life cycle. Modern characterization relies on powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and vibrational spectroscopy, increasingly supplemented by machine-learning models that predict which crystal forms are likely to exist and which are most stable. Submissions that advance the ability to detect, quantify, and prevent unwanted solid-state transformations will sit squarely within the issue’s remit.

The second topic broadens the view from the particle to the finished product, inviting work on advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms, as well as advanced drug delivery systems. Each route imposes its own engineering constraints. Oral solid dosage forms, still the dominant category worldwide, must survive manufacturing stresses, gastric acid, and intestinal transit before releasing their payload. Injectable formulations face the strictest sterility and tolerability requirements, and increasingly must accommodate biologics whose large, fragile molecules cannot tolerate the aggressive conditions that small-molecule chemistry permits. Inhalable products demand precise aerodynamic particle-size control, typically in the range of one to five micrometers, so that droplets or particles deposit in the deep lung rather than the throat. Transdermal systems must drive molecules across the skin’s stratum corneum, a barrier so effective that only a small number of drugs possess the right combination of potency and physicochemical properties to cross it passively. Formulation science is the discipline that reconciles these competing demands.

Translational formulation science and scale-up, the fourth topic, addresses the gap that has swallowed countless promising formulations. A process that works flawlessly in a one-kilogram laboratory batch may behave entirely differently at a five-hundred-kilogram commercial scale, because mixing times, drying rates, heat transfer, and shear forces do not scale linearly. Spray drying offers a concrete example: the droplet size distribution produced by an atomizer, the residence time in the drying chamber, and the outlet temperature jointly determine whether the resulting powder is amorphous, partially crystalline, or degraded, and all three parameters shift as equipment size changes. Similarly, hot-melt extrusion depends on screw configuration and residence-time distribution, while wet granulation responds sensitively to binder addition rate and impeller speed. The special issue’s emphasis on translation suggests the editors want studies that document these scale effects quantitatively and propose strategies, whether model-based or empirical, for bridging from development to commercial production.

Emerging manufacturing technologies constitute the fifth topic, and this is arguably where the field is changing fastest. Continuous manufacturing, in which raw materials flow through connected unit operations to emerge as finished tablets, is displacing the traditional batch model in parts of the industry because it offers tighter control, smaller footprints, and faster response to demand. Three-dimensional printing has demonstrated the ability to produce dosage forms with spatially complex drug distributions and patient-specific doses, exemplified by the first regulatory approval of a printed pharmaceutical product. Additive and continuous approaches both depend on deep process understanding, which leads directly to the final topic: Quality by Design and Process Analytical Technology. QbD is the regulatory philosophy, codified in international guidelines, that manufacturers must design quality into a product by understanding how formulation and process variables affect critical quality attributes, rather than testing quality in afterward. PAT supplies the instruments, near-infrared and Raman spectroscopy most prominently, that monitor those attributes in real time inside the process.

The convergence of these themes reflects a broader shift in how pharmaceutical development is practiced. Where formulation was once largely empirical, a craft of trial and error conducted by experienced formulators, it is now increasingly computational and data-driven. Mechanistic models of dissolution, digital design spaces that map the relationship between process parameters and product quality, and artificial-intelligence tools that predict formulation performance from molecular structure are all reshaping the discipline. The guest editors’ decision to frame the issue around translational advances, rather than pure discovery, places the emphasis on this integration: particle engineering that anticipates manufacturability, characterization that feeds process control, and formulation strategies validated at production scale. For researchers in academia and industry alike, the June 2026 deadline sets a clear timeline for contributing to that conversation.

The significance for patients should not be overlooked. Nearly every therapeutic advance, from targeted cancer therapies to long-acting injectables for chronic disease, ultimately depends on a dosage form that delivers the right amount of drug to the right place at the right time. Formulation failures have delayed or derailed drugs that might otherwise have reached the market, while formulation breakthroughs have extended the lives of established medicines through improved stability, reduced dosing frequency, and better tolerability. By consolidating the state of the art in particle engineering, solid-state science, advanced manufacturing, and quality-by-design into a single dedicated volume, the Journal of Pharmaceutical Investigation aims to provide both a snapshot of where the field stands and a roadmap for where it must go. Submissions across the six announced topics will be reviewed for the January 2027 issue, and the guest editors, drawing on their combined expertise in drug delivery, formulation technology, and pharmaceutical manufacturing, are positioned to assemble a collection with direct relevance to anyone working to turn molecules into medicines.

Subject of Research: Translational pharmaceutical dosage form development through 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, solubility enhancement, solid-state characterization, Quality by Design, process analytical technology, continuous manufacturing, amorphous solid dispersions, scale-up, pharmaceutical manufacturing, Journal of Pharmaceutical Investigation