Particle Engineering and Formulation Science Move Toward Translational Drug Development

A major new special issue of the Journal of Pharmaceutical Investigation is set to gather cutting-edge research on how particle engineering and formulation science are transforming the way medicines are designed, manufactured, and delivered to patients. 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 led 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 are inviting contributions that span the full journey of a drug product, from the manipulation of individual particles in the laboratory to the scale-up of commercial manufacturing lines.

The central theme of the issue is translation, the often difficult passage of a promising formulation concept from bench research into a dosage form that can be reliably produced, tested, and approved. In pharmaceutical development, that passage is notoriously fraught. A molecule that shows excellent activity in early studies may fail later simply because it cannot be dissolved in the gastrointestinal tract, cannot be stabilized in a tablet or injectable suspension, or cannot be manufactured at scale with consistent quality. The special issue explicitly targets these bottlenecks, framing particle engineering and formulation science as the disciplines that bridge discovery chemistry and real-world patient benefit.

Particle engineering sits at the heart of modern dosage form design. At its most basic level, the field concerns controlling the physical attributes of drug particles: their size, size distribution, shape, surface properties, and solid-state form. Each of these attributes can dramatically alter how a drug behaves in the body. Reducing particle size into the micrometer or nanometer range increases the surface area available for dissolution, which is critical for poorly water-soluble compounds that now dominate the development pipeline. Controlling crystal form, whether a drug exists as a crystalline polymorph, a salt, a cocrystal, or an amorphous solid, affects not only solubility but also stability, hygroscopicity, mechanical behavior during tableting, and ultimately shelf life. The special issue calls for work on particle engineering approaches that enhance solubility, stability, and bioavailability, a trio of properties that together determine whether a formulation will succeed clinically.

The scope of the issue extends well beyond oral solid dosage forms. Contributions are invited on advanced formulation strategies for oral, injectable, inhalable, and transdermal products, among others, as well as advanced drug delivery systems. Each of these routes presents its own engineering challenges. Injectable formulations must balance drug concentration, osmolality, and sterility while avoiding precipitation upon administration. Inhalable products depend on precise aerodynamic particle sizing, typically in the range of one to five micrometers, so that drug particles reach the deep lung rather than depositing in the mouth and throat. Transdermal systems must overcome the formidable barrier of the stratum corneum, the outermost layer of skin, often using chemical enhancers, microneedles, or other permeation strategies. By covering all of these routes in a single issue, the editors signal that the underlying science of particles and formulation is a common thread across the entire pharmaceutical landscape.

Solid-state characterization and control form another pillar of the call for papers. In recent decades, pharmaceutical scientists have come to appreciate that the solid state of a drug is not a fixed property but a design variable. A single molecule can exist in multiple polymorphic forms, each with a distinct crystal lattice and therefore distinct thermodynamic behavior. It can also be processed into amorphous dispersions, co-amorphous systems, or cocrystals that alter dissolution profiles without changing the molecule itself. Characterizing these forms requires a battery of analytical techniques, including X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic methods such as Raman and solid-state nuclear magnetic resonance. Crucially, the issue emphasizes control as well as characterization: understanding how a solid form transforms during processing, storage, and administration, and designing formulations that remain in the intended state throughout their lifecycle.

Translational formulation science and scale-up represent perhaps the most commercially significant topic in the issue. Moving a formulation from a laboratory mixer to a pilot plant and then to full commercial production is rarely straightforward. Processes such as wet granulation, hot-melt extrusion, spray drying, and high-shear mixing behave differently at different scales, and small changes in equipment geometry, temperature profiles, or processing times can shift critical quality attributes of the final product. Translational research in this area seeks predictive models and design principles that allow formulators to anticipate these scale effects, reducing the number of costly trial batches and shortening development timelines. Work that connects laboratory-scale understanding to commercial manufacturing realities is explicitly within the scope of the special issue.

Emerging manufacturing technologies constitute a further focus. The pharmaceutical industry has historically relied on batch processing, in which materials move stepwise through discrete unit operations. Continuous manufacturing, by contrast, integrates these steps into a single flowing production line, offering tighter control, smaller footprints, and faster response to demand. Additive manufacturing, including various three-dimensional printing approaches, opens the possibility of dosage forms with complex internal geometries and, in principle, personalized doses tailored to individual patients. Other emerging technologies include advanced milling and micronization methods, novel crystallization techniques, and precision coating processes. The special issue invites research on how such technologies can be incorporated into dosage form design and commercial production, a question that touches on regulatory acceptance as much as on engineering feasibility.

Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, round out the thematic scope. QbD is a regulatory and scientific philosophy that treats quality as something built into a product by design rather than tested in at the end. Under a QbD framework, developers identify the critical quality attributes that matter to patients, determine the critical process parameters and material attributes that influence them, and establish a design space within which the product can be manufactured with assured quality. PAT provides the analytical machinery to make this vision operational: real-time or near-real-time sensors, such as near-infrared and Raman spectroscopy probes, that monitor processes as they run, feeding data to control systems that can adjust parameters on the fly. Applications of QbD and PAT to pharmaceutical formulation and manufacturing are explicitly listed among the topics the editors wish to see, reflecting their growing centrality to both industry practice and regulatory expectations worldwide.

The timing of the special issue is notable. Poor aqueous solubility remains one of the most persistent obstacles in drug development, with a large fraction of new chemical entities emerging from discovery pipelines classified as poorly soluble. At the same time, biologics and complex delivery modalities are expanding the boundaries of what a dosage form must accomplish. Against this backdrop, the disciplines highlighted by the guest editors, particle engineering, formulation science, solid-state control, translational scale-up, emerging manufacturing, and quality-by-design approaches, collectively describe the toolkit that modern pharmaceutical scientists use to convert molecules into medicines. The Journal of Pharmaceutical Investigation, published by Springer, has positioned itself as a venue where these translational questions can be addressed in depth, and the January 2027 issue is intended to consolidate that conversation.

For researchers in academia, industry, and regulatory science, the call for papers represents an opportunity to contribute to a collection that deliberately spans the distance between the nanometer scale of a drug crystal and the industrial scale of a production facility. Submissions are due by June 30, 2026, and prospective authors are directed to the guest editors at Yonsei University, Pusan National University, and Duksung Women’s University for further information. As the pharmaceutical field continues to grapple with increasingly difficult molecules and increasingly sophisticated delivery demands, the special issue promises a snapshot of how particle-level science is being translated into dosage forms that patients can actually use, a translation on which the entire enterprise of pharmacotherapy ultimately depends.

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

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Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, pharmaceutical dosage forms, Journal of Pharmaceutical Investigation, translational research