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

Pharmaceutical science is quietly undergoing one of its most consequential transformations in decades, and a forthcoming special issue of the Journal of Pharmaceutical Investigation aims to capture the moment. Scheduled for publication in January 2027, the issue will be devoted to translational advances in pharmaceutical dosage form development based on particle engineering and formulation science, with a submission deadline of 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 collection arrives at a time when the gap between a molecule’s laboratory promise and its clinical performance has never been more visible or more expensive to close.

The central problem the field confronts is deceptively simple to state. A majority of drug candidates emerging from modern discovery pipelines are poorly soluble in water, and poor solubility translates directly into poor absorption, erratic exposure in patients, and failed development programs. Particle engineering attacks this problem at its physical root. By manipulating crystal form, particle size, morphology, and surface properties, scientists can transform an intractable molecule into a formulation that dissolves fast enough, stays stable long enough, and manufactures reliably enough to reach pharmacy shelves. The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, signaling that these remain the discipline’s defining challenges.

At the heart of particle engineering lies solid-state science. The same molecule can crystallize into multiple polymorphic forms, each with a distinct arrangement of molecules in the solid lattice and, consequently, distinct solubility, melting behavior, mechanical properties, and physical stability. Regulatory agencies require manufacturers to identify and control the relevant solid form because an unanticipated polymorph can undermine a product’s performance, as the industry learned from high-profile cases in which a more stable, less soluble form appeared during production and forced reformulation. Amorphous solid dispersions, in which a drug is molecularly dispersed in a glassy polymer matrix, trade thermodynamic stability for a dramatic solubility advantage, and controlling the delicate balance between amorphous and crystalline states remains an active frontier of research that the issue’s third listed topic, solid-state characterization and control, addresses directly.

Characterization itself has become a sophisticated, multi-technique enterprise. Powder X-ray diffraction reveals crystal structure, differential scanning calorimetry probes thermal transitions such as glass transition temperatures and melting events, dynamic vapor sorption quantifies hygroscopicity, and spectroscopic methods such as Raman and near-infrared imaging map the spatial distribution of drug and excipient within a dosage unit. Particle size distributions are now routinely characterized not only by laser diffraction but by imaging techniques that capture shape and surface texture, both of which influence flow, blending, and dissolution. The translational challenge is that a formulation optimized at the gram scale in a research laboratory must retain its critical quality attributes when produced in tonnes, and the analytical methods used to assure that consistency must themselves be validated, robust, and in many cases deployed in real time on the factory floor.

That manufacturing dimension is where the special issue’s scope becomes especially forward-looking. Among the topics the editors list are emerging manufacturing technologies in dosage form design and commercial production, a category that encompasses hot-melt extrusion, spray drying, and increasingly additive manufacturing approaches such as three-dimensional printing of dosage forms. Hot-melt extrusion, borrowed originally from polymer processing, melts a drug together with polymeric carriers and shapes the extrudate into tablets, granules, or films, enabling amorphous dispersions to be produced continuously rather than batch by batch. Spray drying, long the workhorse of inhalation powder production, converts a drug solution or suspension into engineered particles with precisely tuned aerodynamic diameters. Continuous manufacturing, in general, is reshaping the economics of pharmaceutical production by replacing sequential batch operations with integrated, steady-state processes that offer tighter control and faster technology transfer from development to commercial scale.

Underpinning much of this industrial evolution is the quality paradigm known as Quality by Design, or QbD, paired with Process Analytical Technology, or PAT. QbD inverts the traditional approach to pharmaceutical quality. Instead of testing finished products to detect defects, developers design formulations and processes around a scientific understanding of which parameters critically affect quality, define a design space within which those parameters may vary, and build control strategies that keep the process inside that space. PAT supplies the sensory apparatus for this philosophy: inline and online instruments, such as near-infrared probes and Raman spectrometers, feed real-time data into process models, allowing operators to monitor blend uniformity, drying endpoints, and granule properties as the process runs rather than waiting for laboratory results. The special issue’s inclusion of QbD and PAT applications reflects how thoroughly these frameworks have moved from regulatory aspiration to daily practice in formulation and manufacturing science.

The breadth of dosage forms covered by the issue is equally telling. The editors invite advanced formulation strategies spanning oral, injectable, inhalable, and transdermal routes, along with advanced drug delivery systems more broadly. Each route imposes its own particle engineering demands. Oral solid dosage forms must survive gastric transit and release drug at the right site and rate. Injectable formulations, particularly the biologic drugs that now dominate pipelines, demand control of aggregation, particulate contamination, and viscosity at high concentrations. Inhaled medicines require particles engineered to aerodynamic diameters of roughly one to five micrometers so they deposit in the lung rather than the throat or the exhaled air, a constraint that has made particle engineering inseparable from inhalation product design. Transdermal systems, whether adhesive patches or microneedle arrays, must overcome the skin’s formidable barrier function while remaining comfortable and manufacturable at scale.

Translational formulation science, the connective tissue of the entire issue, is the discipline of carrying a formulation across the valley that separates discovery from the clinic and the clinic from commerce. Scale-up is rarely a matter of simply making more of a successful laboratory process. Mixing times, heat transfer, shear rates, and drying kinetics all change with equipment size and geometry, and a formulation whose critical quality attributes depend sensitively on any of these variables can fail at scale in ways no bench experiment predicted. Modern practice therefore emphasizes process understanding and modeling from the outset, using tools such as computational fluid dynamics, discrete element modeling of powder behavior, and mechanistic dissolution modeling to anticipate scale effects before they occur. The guest editors’ emphasis on translation suggests the issue will favor work that demonstrates not just novelty at the bench but a credible path to drug product development.

The timing of the call is significant for the broader pharmaceutical ecosystem. Drug pipelines are increasingly dominated by molecules that resist conventional formulation: poorly soluble small molecules, large biologics that cannot survive the digestive tract, and emerging modalities such as RNA therapeutics and gene editing systems that demand entirely new delivery vehicles. Formulation science and particle engineering are the disciplines charged with converting these fragile, difficult molecules into stable, manufacturable, patient-acceptable medicines. Advances in nanosuspensions, lipid nanoparticles, amorphous systems, and controlled-release architectures are therefore not incremental refinements but enabling technologies for entire therapeutic classes. A special issue that gathers solubility enhancement, solid-state control, novel manufacturing, and quality-by-design under one translational umbrella mirrors the way leading development organizations now operate, where formulation scientists, process engineers, and analytical teams work in parallel rather than in sequence.

For researchers considering submission before the June 30, 2026 deadline, the scope outlined by Hwang, Kim, and Park offers a clear signal of the field’s priorities: rigorous science that demonstrably moves dosage forms closer to patients. The Journal of Pharmaceutical Investigation, published by Springer, has positioned itself as a venue where Asian pharmaceutical science and international research communities intersect, and a 2027 issue devoted to translational particle engineering and formulation science is likely to serve as a snapshot of where the discipline stands as continuous manufacturing matures, regulatory frameworks evolve toward real-time quality assurance, and the industry confronts a generation of drug candidates that will succeed or fail on the strength of their formulations. In an era when headlines celebrate molecular targets and clinical breakthroughs, the quieter science of particles, powders, and processes remains the indispensable bridge between a promising molecule and a medicine on the shelf, and the field’s leading practitioners are now documenting exactly how that bridge is built.

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 solubility, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, drug delivery systems, scale-up, amorphous solid dispersions, Journal of Pharmaceutical Investigation