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

A new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation science, with a focus on how laboratory-scale particle engineering and formulation strategies make the leap into real-world medicines. The issue, tentatively titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, is scheduled for publication in January 2027, with a submission deadline of June 30, 2026. It will be guided by three guest editors from South Korea: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Together they represent a research community that has become increasingly influential in bridging the gap between molecular pharmacology and the industrial machinery that turns molecules into tablets, injections, inhalers, and patches.

The premise behind the issue is deceptively simple: a drug molecule is only as useful as the dosage form that delivers it. Many of the most promising compounds emerging from discovery pipelines today are poorly soluble in water, chemically fragile, or difficult to absorb through biological membranes. Particle engineering addresses these problems at the physical level, manipulating crystal form, particle size, surface properties, and morphology to change how a drug dissolves, remains stable on the shelf, and ultimately reaches the bloodstream. The special issue explicitly invites contributions on particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that the editors see this as the foundational layer upon which modern dosage form design is built.

The scientific stakes are considerable. Estimates across the pharmaceutical literature consistently suggest that a large fraction of new chemical entities, and an even larger share of compounds emerging from high-throughput screening, fall into the Biopharmaceutics Classification System classes II and IV, meaning their absorption is limited by poor aqueous solubility. Techniques such as micronization, nanocrystal formation, amorphous solid dispersion, hot-melt extrusion, spray drying, and supercritical fluid processing have each been developed to confront this barrier. Each method reshapes the solid state of the drug in a different way: reducing particle size to increase surface area, disrupting crystal lattices to raise apparent solubility, or stabilizing metastable polymorphs that dissolve faster than their thermodynamically favored counterparts. The catch, and a recurring theme in translational formulation science, is that these engineered states are often physically unstable, prone to recrystallization, aggregation, or phase conversion during storage and processing.

This is where solid-state characterization enters the picture. The special issue calls for work on solid-state characterization and control in pharmaceutical development, a discipline that combines X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, spectroscopic methods, and increasingly sophisticated computational modeling to understand exactly what form a drug is in and how that form behaves. Polymorphism, the ability of a single molecule to crystallize in multiple distinct lattice arrangements, remains one of the most consequential and litigated phenomena in the industry, because different polymorphs can exhibit different solubility, dissolution rates, mechanical properties, and stability profiles. Controlling the solid state is therefore not an academic nicety; it determines whether a product can be manufactured reproducibly, whether it survives humidity and temperature stress, and whether regulators will approve it.

Beyond the solid state, the issue’s scope extends to advanced formulation strategies across essentially every route of administration: oral, injectable, inhalable, transdermal, and other delivery systems. Each route imposes its own engineering constraints. Oral formulations must survive gastric acid and enzymatic attack before releasing their payload in the intestine. Injectable products demand strict control of sterility, particle contamination, and osmolality, and increasingly rely on lipid nanoparticles and polymeric carriers for biologics and nucleic acid therapeutics. Inhaled medicines require particles engineered to aerodynamic diameters typically in the range of one to five micrometers so they can deposit in the deep lung rather than being exhaled or trapped in the throat. Transdermal systems must push molecules across the stratum corneum, the skin’s remarkably effective barrier, using chemical enhancers, microneedles, or iontophoresis. The fact that a single issue can span all of these routes reflects how particle and formulation science has become a unifying language across delivery technologies.

Perhaps the most distinctive emphasis of the special issue, and the one captured in its title, is translation. The editors are asking for work on translational formulation science and scale-up of drug products, which addresses a notorious weak point in pharmaceutical research. A formulation that performs beautifully in a one-liter beaker may fail spectacularly when produced in a two-thousand-liter vessel, where mixing times, heat transfer, drying kinetics, and shear forces all change. Scale-up failures can alter particle size distributions, polymorphic content, and blend uniformity in ways that compromise both efficacy and regulatory compliance. Translational formulation science seeks to anticipate these shifts through mechanistic process models, material science characterization of excipients and active ingredients, and careful design of experiments that map how process variables propagate into product quality.

Emerging manufacturing technologies form another pillar of the call for papers. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than moving between batch steps, has gained regulatory momentum because it offers tighter process control, smaller footprints, and the ability to adjust production volume rapidly. Additive manufacturing, commonly known as three-dimensional printing, has opened the possibility of dosage forms with complex internal geometries and, in principle, patient-specific dosing. Electrospinning, microfluidics, and advanced spray-based techniques are being explored to produce engineered particles with architectures that conventional milling and crystallization cannot achieve. The special issue’s invitation for contributions on emerging manufacturing technologies in dosage form design and commercial production suggests the editors want to see not just novel laboratory demonstrations but evidence that these approaches can survive contact with commercial reality.

Woven through all of these topics is the regulatory and analytical framework of Quality by Design and Process Analytical Technology. Quality by Design, or QbD, inverts the traditional approach to pharmaceutical development: instead of testing finished products and rejecting failures, developers build a scientific understanding of how formulation and process variables affect critical quality attributes, then design the product and process to stay within a proven region of acceptable performance. Process Analytical Technology, or PAT, supplies the real-time eyes for this philosophy, using inline and online sensors such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement to monitor blend uniformity, granulation endpoints, drying progress, and crystallization as they happen. Together, QbD and PAT shift quality from an inspection outcome to an engineered property, and both regulators and manufacturers have invested heavily in their adoption. The special issue’s explicit call for QbD and PAT applications in formulation and manufacturing underscores that computational and analytical rigor is now inseparable from dosage form innovation.

The timing of the issue, arriving in early 2027, positions it to capture a field in rapid flux. The rise of biologics, mRNA therapeutics, and antibody-drug conjugates has expanded the formulation scientist’s brief far beyond small-molecule tablets, demanding new excipient systems, cold-chain-compatible lyophilization cycles, and delivery vehicles that protect fragile macromolecules. At the same time, artificial intelligence and machine learning are beginning to influence formulation development, from predicting polymorph stability to optimizing process parameters, adding a computational layer to what has historically been an empirical discipline. Researchers working at any of these intersections, whether in academia, generic and innovator pharmaceutical companies, or contract development and manufacturing organizations, now have a defined venue and deadline: submissions are due by June 30, 2026, for an issue that promises to map how particle engineering and formulation science carry new medicines from the bench to the pharmacy shelf.

For patients, the significance of this largely invisible branch of pharmaceutical science is difficult to overstate. A breakthrough molecule that cannot be dissolved, stabilized, or manufactured at scale is, in practical terms, not a medicine at all. The disciplines gathered under this special issue, spanning particle engineering, solid-state control, advanced delivery systems, translational scale-up, emerging manufacturing, and quality-by-design frameworks, collectively determine whether the drugs of the next decade arrive as effective, affordable, and reliable products. By convening international contributions under a single translational banner, the Journal of Pharmaceutical Investigation and its guest editors are betting that the next wave of therapeutic progress will depend as much on the engineering of particles and processes as on the discovery of the molecules themselves.

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, bioavailability, solid-state characterization, polymorphism, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, dosage forms