At first glance, a special issue announcement might seem like administrative housekeeping, but the topics it collects reveal where the pharmaceutical industry’s bottleneck truly lies. Discovering a molecule that binds to a disease target has become, in many cases, the easier half of the problem. The harder half is turning that molecule into a dosage form—a tablet, an injection, an inhaler, or a skin patch—that delivers the right amount of drug to the right place at the right time. An estimated large fraction of drug candidates in development pipelines are poorly soluble in water, which means the body cannot absorb them efficiently no matter how potent they are in a laboratory dish. Particle engineering, the deliberate manipulation of crystal form, particle size, shape, and surface properties, has emerged as one of the most powerful levers for overcoming this barrier.

The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement. This trio of properties sits at the heart of formulation science. Solubility determines whether a drug can dissolve in gastrointestinal fluids or blood; stability determines whether it survives storage and the harsh chemistry of the body; bioavailability determines how much of the administered dose actually reaches the bloodstream in an active form. These properties are not independent. A technique that boosts solubility, such as converting a crystalline drug into an amorphous solid dispersion, can simultaneously undermine physical stability, because amorphous materials tend to revert to their less soluble crystalline state over time. Researchers in this field therefore work in a constant state of trade-off management, and the translational question—does the trick still work at manufacturing scale and in real patients—separates publishable novelty from genuinely useful medicine.

Among the technical strategies the issue will cover are advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms, along with broader advanced drug delivery systems. Each route of administration imposes its own engineering demands. Oral formulations must survive stomach acid and enzymatic attack before releasing their payload in the intestine. Injectable formulations must be sterile, isotonic, and free of particles that could trigger immune reactions, which places strict constraints on particle size and excipient choice. Inhalable medicines, increasingly central to treating respiratory diseases and even enabling systemic delivery through the lungs, require particles engineered to aerodynamic diameters in the range of roughly one to five micrometers so they deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push molecules through the stratum corneum, the skin’s remarkably effective barrier, often relying on chemical enhancers, microneedles, or carefully tuned adhesive matrices.

Solid-state characterization and control form another pillar of the call for papers. The same molecule can exist in multiple crystalline forms, known as polymorphs, each with different solubility, melting behavior, and mechanical properties. The most infamous cautionary tale is ritonavir, an HIV drug that spontaneously converted to a more stable, far less soluble polymorph in the late 1990s, forcing a market withdrawal and a costly reformulation. Modern regulatory frameworks expect developers to identify which solid form they are making, demonstrate that the process reliably produces it, and show that it will not transform during storage. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to fingerprint these forms, while in-line sensors increasingly monitor them during production rather than only in the quality-control laboratory afterward.

That shift from testing finished batches to monitoring processes as they run connects directly to two of the special issue’s named themes: Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT. QbD is a regulatory philosophy, championed by agencies including the U.S. Food and Drug Administration, that holds that quality should be designed into a product from the start rather than inspected in at the end. In practice, this means systematically identifying the critical material attributes of a formulation and the critical process parameters of its manufacture, then building a design space within which those variables can fluctuate without compromising the final product. PAT supplies the instrumentation—near-infrared spectroscopy, Raman spectroscopy, focused beam reflectance measurement, and similar tools—that makes real-time control possible. Together they promise shorter development timelines, fewer batch failures, and a more agile response to supply disruptions, which recent global events have shown the industry cannot afford to ignore.

The emphasis on translational formulation science and scale-up signals that the editors are looking beyond elegant laboratory demonstrations. A nanoparticle suspension that enhances bioavailability in a beaker means little if it cannot be milled, sprayed, dried, and packaged by the ton with consistent quality. Scale-up is where many promising technologies stall. Hot-melt extrusion, which forces a drug and polymer through a heated screw system to create amorphous dispersions, must be translated from benchtop extruders to industrial lines processing hundreds of kilograms per hour while keeping temperatures and residence times within tight windows. Spray drying, a workhorse for producing engineered inhalable and amorphous particles, demands control of droplet formation, drying kinetics, and powder collection at scales where small changes in airflow can alter particle morphology. Continuous manufacturing, which replaces traditional batch processing with a steady flow of material through connected unit operations, is increasingly seen as the answer, and it dovetails naturally with PAT because sensors can be embedded along the production line.

Emerging manufacturing technologies in dosage form design constitute another invited topic, and this is where the field’s creative frontier is most visible. Additive manufacturing, or three-dimensional printing, has already produced the first FDA-approved printed drug product, a rapidly disintegrating levetiracetam tablet whose porous structure was impossible to make by conventional compression. Printing opens the door to personalized dosages, combination products with spatially separated ingredients, and complex release profiles encoded in a tablet’s internal geometry. Other emerging approaches include microfluidic production of uniformly sized lipid nanoparticles, which became household technology through mRNA vaccines, and supercritical fluid techniques that generate solvent-free engineered particles. Each of these methods raises its own regulatory and manufacturing questions, which is precisely why a journal dedicated to pharmaceutical investigation considers translational framing essential.

The geographic and institutional context of this special issue is also noteworthy. The Journal of Pharmaceutical Investigation, published by Springer, has long served as a prominent venue for pharmaceutical formulation and drug delivery research, with particularly strong roots in the Asian pharmaceutical science community. The three guest editors bring complementary expertise spanning the lifecycle the issue describes. Sung-Joo Hwang’s work at Yonsei University encompasses pharmaceutical formulation and drug delivery system development with extensive industrial collaboration. Min-Soo Kim’s research at Pusan National University focuses on particle engineering and physical pharmacy approaches to improving drug properties. Heejun Park’s work at Duksung Women’s University addresses formulation and delivery science with an eye toward clinical application. Their combined perspective suggests the issue will weigh practical manufacturability and regulatory readiness alongside scientific novelty.

For researchers, the June 30, 2026 deadline provides a clear target for submitting studies that connect molecular-level understanding to dosage-form reality. For the wider public, the significance is easier to state than to see: nearly every medicine a patient takes is the product of exactly the science this issue celebrates. The difference between a drug that fails in clinical trials for lack of exposure and one that succeeds often traces back to a crystallization protocol, a polymer selection, or a milling parameter chosen years earlier. By consolidating advances in particle engineering, solid-state control, quality-by-design manufacturing, and next-generation delivery platforms into a single translational collection, the January 2027 issue aims to shorten the distance between what chemists can synthesize and what patients can actually benefit from. In an era when biologics, nucleic acid therapeutics, and increasingly insoluble small molecules are straining conventional formulation toolkits, that distance is where the future of pharmacotherapy is being decided, one engineered particle at a time.

Subject of Research: Translational pharmaceutical formulation science and particle engineering for 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, scale-up, continuous manufacturing, amorphous solid dispersions, pharmaceutical manufacturing, dosage forms