Particle Engineering Takes Center Stage in Push to Translate Drug Formulation Science

Pharmaceutical scientists are preparing to showcase a new wave of translational research in drug formulation, as the Journal of Pharmaceutical Investigation announces a special issue dedicated to advances in pharmaceutical dosage form development built on particle engineering and formulation science. The issue, scheduled for publication in January 2027, is being assembled by three guest editors based in South Korea: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Researchers have until June 30, 2026, to submit their work, and the editors are inviting contributions that span the full journey from laboratory-scale particle design to commercially manufactured drug products.

The central premise of the special issue is that the physical form of a drug particle is not a minor technical detail but a decisive factor in whether a medicine actually works in patients. Many of the most promising drug molecules discovered in recent decades, particularly large fractions of new small-molecule candidates, dissolve poorly in water. Poor solubility means the drug may pass through the gastrointestinal tract without being adequately absorbed, forcing developers to give higher doses, accept inconsistent exposure, or abandon the molecule altogether. Particle engineering offers a toolkit for confronting this problem directly, by manipulating crystal form, particle size, surface properties, and morphology to improve how a drug dissolves, remains stable on the shelf, and ultimately reaches the bloodstream.

Among the topics the editors highlight are particle engineering approaches aimed specifically at enhancing solubility, stability, and bioavailability. Techniques in this space include micronization and nanonization, which increase the surface area available for dissolution; amorphous solid dispersion, in which a crystalline drug is converted into a disordered, higher-energy state stabilized within a polymer matrix; and cocrystal and salt formation, which alter the crystal lattice itself. Each strategy involves trade-offs. Amorphous forms dissolve faster but tend to revert to more stable, less soluble crystals over time, a process known as recrystallization. Nanoparticles dissolve rapidly but can aggregate during storage or processing. The special issue is expected to gather studies showing how researchers manage these trade-offs with increasingly sophisticated control over solid-state properties.

Solid-state characterization and control form another pillar of the call for papers. Modern analytical methods allow scientists to probe the arrangement of molecules inside a powder with remarkable precision. X-ray powder diffraction reveals crystal structure, differential scanning calorimetry measures thermal transitions such as melting and glass transitions, and spectroscopic techniques such as Raman and near-infrared analysis detect subtle changes in molecular environment. Beyond static characterization, the field is moving toward real-time monitoring, so that manufacturers can detect whether a drug substance has transformed into an unwanted polymorph, a different crystal arrangement with potentially different solubility and stability, during processing rather than discovering the change months later in stability testing.

The scope of the issue extends well beyond oral tablets and capsules. The editors explicitly invite work on advanced formulation strategies for injectable, inhalable, and transdermal dosage forms, as well as other routes of administration and advanced drug delivery systems. Each route imposes its own particle-level demands. Inhaled medicines require particles engineered to a precise aerodynamic size range, typically a few micrometers, so they deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable formulations must balance particle size and sterility requirements, particularly for long-acting depot suspensions designed to release drug over weeks or months. Transdermal systems depend on formulation chemistry that drives drug molecules through the skin barrier at controlled rates. Advances in one route often inspire progress in others, which is precisely the kind of cross-pollination the special issue aims to capture.

Perhaps the most consequential theme is translational formulation science and scale-up. A formulation that performs beautifully in a laboratory beaker frequently fails when transferred to industrial equipment, where mixing dynamics, drying rates, heat transfer, and mechanical stresses differ dramatically. Scale-up failures are a well-known source of delays in drug development, and regulatory agencies scrutinize them closely because changes in manufacturing conditions can alter critical quality attributes of the final product. Research that demonstrates how a particle-engineered formulation retains its performance as production moves from grams to kilograms to commercial batches addresses one of the most persistent bottlenecks in bringing new medicines to patients.

Emerging manufacturing technologies represent a rapidly growing area within this landscape. Continuous manufacturing, in which drug product is produced in a flowing process rather than in discrete batches, is gaining ground because it offers tighter control, smaller footprints, and easier integration of real-time quality checks. Additive manufacturing, including various printing technologies, enables dosage forms with complex internal geometries and personalized doses. Hot-melt extrusion, spray drying, and supercritical fluid technologies continue to evolve as methods for generating engineered particles at scale. The special issue invites contributions describing how such technologies are being designed, validated, and implemented in commercial production, a step that separates laboratory novelty from genuine industrial impact.

Woven through all of these topics is the framework of Quality by Design, commonly abbreviated as QbD, together with Process Analytical Technology, or PAT. Quality by Design is a regulatory philosophy, championed for years by agencies including the U.S. Food and Drug Administration, that asks developers to build quality into a product by design rather than testing it in afterward. Developers identify the critical quality attributes that matter to patients, determine the formulation and process parameters that control those attributes, and establish a design space within which the product reliably meets its specifications. Process Analytical Technology supplies the sensors and data systems that make this possible in practice, using inline and online measurements to track critical parameters during manufacturing. The editors specifically call for papers on QbD and PAT applications in pharmaceutical formulation and manufacturing, reflecting how central these frameworks have become to modern drug development.

The timing of the special issue reflects broader momentum in the field. As drug pipelines fill with increasingly difficult molecules, including poorly soluble compounds and complex biological products, the pharmaceutical industry has come to regard formulation science as a strategic capability rather than a downstream service function. Academic groups, generic and innovator companies, and contract development organizations are all investing in particle engineering platforms, and regulatory pathways have matured to accommodate novel dosage forms and manufacturing methods. A dedicated venue for translational work, published in a journal that reaches both academic and industry audiences, gives researchers an incentive to report not just elegant science but evidence that their approaches survive the rigors of scale-up, regulatory expectations, and real-world production.

For researchers considering submission, the June 30, 2026 deadline leaves roughly a year and a half for preparing manuscripts, and the January 2027 publication date positions the issue to capture the state of the art as it stands in the middle of the decade. The guest editors, drawing on their combined expertise across drug delivery systems, pharmaceutical manufacturing, and formulation development, are positioned to curate a collection that spans fundamental particle science through to commercial application. For the wider field, the issue promises a snapshot of how particle engineering and formulation science are converging to turn difficult molecules into dependable medicines, a transformation that happens quietly inside powders and crystals but ultimately determines whether a drug discovered in the laboratory can fulfill its promise at the bedside.

Subject of Research: Translational pharmaceutical formulation development using particle engineering and manufacturing 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, bioavailability, solid-state characterization, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, dosage forms, pharmaceutical manufacturing