Particle Engineering Takes Center Stage as Pharmaceutical Formulation Science Pushes Toward the Clinic

A new special issue of the Journal of Pharmaceutical Investigation is set to spotlight one of the most consequential yet underappreciated frontiers in modern medicine: the science of turning molecules into medicines. Titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, the collection will be published in January 2027, with submissions accepted through June 30, 2026. Guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, the issue aims to gather research that bridges the gap between laboratory-scale formulation breakthroughs and the drug products that actually reach patients.

The premise behind the special issue reflects a hard truth of pharmaceutical development: a molecule with perfect biological activity is worthless if it cannot be dissolved, absorbed, stabilized, and manufactured at scale. Industry analysts have long noted that a large fraction of drug candidates entering development pipelines suffer from poor aqueous solubility, a property that can doom otherwise promising compounds before they ever demonstrate their therapeutic potential. Particle engineering, the deliberate manipulation of crystal form, particle size, morphology, and surface properties, has emerged as one of the most powerful toolkits for rescuing these molecules and transforming them into viable dosage forms.

Among the topics the editors have identified for the issue are particle engineering approaches for enhancing solubility, stability, and bioavailability, advanced formulation strategies spanning oral, injectable, inhalable, and transdermal routes, solid-state characterization and control, translational formulation science and scale-up, emerging manufacturing technologies, and the application of Quality by Design and Process Analytical Technology frameworks. Together, these themes map the entire journey of a drug product, from the first crystallization experiment to the commercial production line, and they signal the issue’s distinctly translational orientation.

The solubility challenge deserves particular attention because it sits at the heart of modern drug development. An estimated seventy to ninety percent of molecules in development pipelines are classified as poorly soluble under the biopharmaceutics classification system, meaning their dissolution in the gastrointestinal tract limits how much of the drug actually enters the bloodstream. Formulation scientists respond with an arsenal of particle-level interventions: reducing particle size into the micrometer and nanometer ranges to dramatically increase surface area, converting crystalline materials into amorphous solid dispersions where the drug is molecularly dispersed in a polymer matrix, and engineering cocrystals and salts that alter the thermodynamics of dissolution itself. Each approach trades off benefits and risks, since amorphous forms, for example, offer superior solubility but carry an inherent tendency to revert to more stable, less soluble crystals during storage.

This is where solid-state characterization becomes indispensable. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to determine exactly which physical form of a drug is present in a formulation and to detect even subtle transformations that could compromise performance. A polymorphic conversion during manufacturing or shelf storage can change dissolution rate, stability, and even mechanical properties like tablet hardness. Regulatory agencies worldwide now expect sponsors to demonstrate comprehensive control over solid-state properties, making this once-niche discipline a central pillar of pharmaceutical quality assurance.

The special issue’s emphasis on multiple delivery routes underscores how particle and formulation science must adapt to radically different biological environments. Oral solid dosage forms remain the workhorse of the industry, but inhaled medicines demand particles engineered to precise aerodynamic diameters, typically between one and five micrometers, to deposit in the deep lung rather than the throat. Injectable formulations must balance sterility, isotonicity, and particulate purity with increasingly demanding requirements for biologics such as monoclonal antibodies, which are prone to aggregation. Transdermal systems rely on drug molecules traversing the skin’s formidable barrier, often requiring chemical enhancers, microneedle technologies, or engineered particle systems to achieve therapeutic flux. Each route imposes its own particle engineering constraints, and advances in one domain frequently inspire innovation in the others.

Translational formulation science, another core theme of the issue, addresses the notoriously difficult passage from bench to manufacturing plant. A formulation that performs beautifully when prepared in a one-hundred-gram laboratory batch may fail spectacularly when produced at the ton scale, where mixing dynamics, drying rates, heat transfer, and equipment geometry all change. Scale-up failures are among the most expensive setbacks in pharmaceutical development, sometimes forcing companies to reformulate products late in clinical development. Modern practice increasingly relies on computational modeling, mechanistic understanding of unit operations, and small-scale models that faithfully predict large-scale behavior, allowing scientists to de-risk the transition before committing to full production.

The frameworks of Quality by Design and Process Analytical Technology represent perhaps the most significant cultural shift in pharmaceutical manufacturing over the past two decades. Quality by Design, or QbD, asks developers to build scientific understanding into the product itself, systematically identifying the critical material attributes and process parameters that determine quality, rather than simply testing finished products and hoping for the best. Process Analytical Technology, or PAT, complements this philosophy by embedding real-time sensors, often based on near-infrared or Raman spectroscopy, directly into manufacturing equipment, allowing operators to monitor and control processes as they run. Together, these approaches enable continuous manufacturing, a paradigm in which drug substance and drug product flow seamlessly through connected unit operations rather than pausing for batch-by-batch testing, and which regulators have actively encouraged as a route to more agile and reliable supply chains.

Emerging manufacturing technologies form another pillar of the call for papers. Additive manufacturing, commonly known as three-dimensional printing, has already produced the first FDA-approved printed drug product, a rapidly disintegrating formulation, and continues to attract attention for its ability to personalize doses and create complex release profiles impossible with conventional compression. Hot-melt extrusion, spray drying, supercritical fluid processing, and electrospinning each offer distinct advantages for generating engineered particles and amorphous systems, while continuous manufacturing platforms are being designed to integrate these operations end to end. The guest editors’ inclusion of commercial production among the target topics signals that the issue will value work demonstrating real-world manufacturability, not just laboratory elegance.

For researchers considering submission, the June 30, 2026 deadline provides a substantial runway, and the January 2027 publication date positions the issue to capture a field in rapid evolution. The convergence of artificial intelligence-assisted formulation design, high-throughput experimentation, advanced process analytics, and growing regulatory openness to novel manufacturing paradigms suggests that the translational landscape the editors hope to document is shifting faster than at any point in recent memory. What the special issue ultimately promises is a snapshot of a discipline redefining itself: no longer a downstream service to drug discovery, but a driver of which molecules can become medicines at all. As the boundaries between particle engineering, formulation science, and manufacturing technology continue to blur, the work assembled in this collection may well chart how the next generation of therapies, from poorly soluble small molecules to fragile biologics, make their way from the chemist’s flask to the patient’s bedside.

Subject of Research: Translational pharmaceutical dosage form development based on 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

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