Pharmaceutical Scientists Rally Around Particle Engineering for Next-Generation Drug Forms

A major new special issue of the Journal of Pharmaceutical Investigation is set to spotlight how particle engineering and formulation science are transforming the way medicines are designed, manufactured, and delivered to patients. Scheduled for publication in January 2027, the collection will be titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, and it aims to gather cutting-edge research from laboratories and manufacturing facilities around the world under a single editorial umbrella. The announcement offers a rare, consolidated view of where the pharmaceutical development community believes the next wave of dosage form innovation will come from.

The issue is being led by three guest editors based in South Korea, each bringing a distinct area of expertise to the project. Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University will jointly oversee the selection and review of contributions. Their combined institutional backgrounds span some of the most active pharmaceutical science programs in the country, and the editorial team has framed the issue around a central theme: bridging the gap between laboratory-scale formulation discoveries and commercially viable drug products that can be reliably manufactured at scale.

That translational emphasis is significant because the pharmaceutical industry has long struggled with a well-documented problem: a large proportion of new drug candidates emerging from discovery pipelines are poorly soluble in water. When a molecule dissolves poorly, it is absorbed poorly, and its therapeutic potential is undermined no matter how elegant its biological mechanism may be. Particle engineering offers a family of techniques, including micronization, nanonization, crystal habit modification, and the creation of amorphous solid dispersions, that can dramatically alter how a drug particle interacts with bodily fluids. By reducing particle size to the micrometer or nanometer scale, formulators increase the surface area available for dissolution, which can raise apparent solubility and improve bioavailability without altering the drug molecule itself.

The special issue’s stated topic list makes clear that solubility enhancement is only one strand of a much broader agenda. The editors are soliciting work on advanced formulation strategies across virtually every major route of administration, including oral, injectable, inhalable, and transdermal delivery, as well as broader advanced drug delivery systems. This breadth reflects a growing recognition in the field that dosage form design is no longer a downstream afterthought to drug discovery but a decisive factor in whether a therapeutic candidate ever reaches patients. An inhalable formulation of a biologic, a long-acting injectable suspension, or a transdermal patch each demands a fundamentally different understanding of how particles behave, how excipients interact with active ingredients, and how the final product survives storage, handling, and administration.

Solid-state science occupies a particularly prominent place in the call for papers. The physical form of a drug, whether crystalline or amorphous, which polymorphic form it adopts, whether it forms hydrates or solvates, and how these states change under humidity, temperature, and mechanical stress, can determine both the performance and the regulatory fate of a product. A drug that crystallizes in an unexpected polymorph during manufacturing can exhibit different dissolution behavior, different stability, and even different patent implications. The special issue’s focus on solid-state characterization and control signals that the editors expect submissions describing new analytical methods, real-time monitoring approaches, and strategies for keeping a formulation in its intended physical state from the first gram produced to the final commercial batch.

Scale-up and manufacturing technology form another pillar of the issue. Moving a formulation from a bench-top mixer to a thousand-liter production vessel is notoriously difficult because processes such as wet granulation, spray drying, hot-melt extrusion, and high-shear mixing behave differently at different scales. Heat transfer, mixing efficiency, and drying kinetics do not scale linearly, and small changes in process parameters can shift critical quality attributes of the final product. Emerging manufacturing technologies, including continuous manufacturing platforms that replace traditional batch processing, are increasingly viewed as a way to reduce this variability while cutting costs and shortening development timelines. The editors have explicitly invited work on these emerging technologies as they apply to dosage form design and commercial production.

Woven through the entire topic list is the language of modern pharmaceutical quality systems, specifically Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT. Quality by Design is a regulatory philosophy, championed by agencies including the United States Food and Drug Administration, that asks manufacturers to build quality into a product by design rather than testing it in afterward. Under QbD, developers systematically identify which material attributes and process parameters most affect product quality, then establish a design space within which those variables can vary without compromising the final product. Process Analytical Technology complements this by embedding sensors, such as near-infrared spectroscopy probes and Raman spectrometers, directly into manufacturing equipment, allowing operators to monitor critical attributes in real time rather than waiting for laboratory results from sampled batches.

The combination of QbD and PAT with particle engineering represents one of the most consequential shifts in pharmaceutical manufacturing in recent decades. Instead of treating a granulation endpoint or a spray-drying condition as a fixed recipe, manufacturers can now define multivariate design spaces and use inline analytics to steer processes dynamically. For particle-engineered products, where a few degrees of temperature change during drying can convert a useful amorphous dispersion into a poorly performing crystalline one, this level of process understanding is not a luxury but a necessity. The special issue’s inclusion of these frameworks suggests the editors anticipate submissions that demonstrate how analytical and control technologies enable the reliable industrial production of sophisticated new dosage forms.

The timeline laid out by the editorial team gives researchers a clear runway. Submissions are due by June 30, 2026, with the completed issue slated for January 2027. That schedule positions the collection to capture work that is currently in progress across academia and industry, and it arrives at a moment when the pharmaceutical sciences community is grappling with an increasingly difficult portfolio of molecules. Large biologics, antibody-drug conjugates, RNA therapeutics, and poorly soluble small molecules all strain conventional formulation approaches, and the demand for delivery technologies that can stabilize, protect, and release these compounds precisely is intensifying.

For the broader field, the special issue functions as both a snapshot and a signal. It identifies particle engineering and formulation science as the engines of translational progress in drug delivery, and it draws attention to the Korean pharmaceutical science community’s role in convening that conversation through the Journal of Pharmaceutical Investigation. Whether the resulting collection ultimately shapes how regulators think about emerging manufacturing technologies, how companies design their next generation of products, or how universities train the formulators of the future, its central premise is one that few in the industry would dispute: the path from a promising molecule to a medicine patients can actually use runs directly through the science of particles and the formulations built from them.

Subject of Research: Translational pharmaceutical dosage form development using 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, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, scale-up, dosage forms, solubility enhancement, Journal of Pharmaceutical Investigation