Pharmaceutical Scientists Rally Around Particle Engineering as Drug Delivery Hits a Translational Crossroads

A major push is underway to close one of the most persistent gaps in modern medicine: the distance between a brilliant drug molecule in the laboratory and a medicine that actually works in a patient’s body. The Journal of Pharmaceutical Investigation has announced a special issue devoted to translational advances in pharmaceutical dosage form development, with a focus 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 for consideration.

The premise behind the initiative is deceptively simple. A new drug molecule, no matter how elegantly designed to hit its biological target, is chemically inert powder until someone turns it into a tablet, a capsule, an injection, an inhaler, or a patch. That transformation is the domain of formulation science, and it has become one of the decisive bottlenecks in drug development. Industry estimates consistently suggest that a large fraction of candidate molecules emerging from discovery pipelines are poorly soluble in water, which means they dissolve too slowly or incompletely in the gastrointestinal tract to reach therapeutic concentrations in the blood. Particle engineering, the deliberate manipulation of crystal form, particle size, shape, and surface properties, has become the central toolkit for rescuing such molecules.

The special issue’s scope reflects this reality. Among the topics the editors have flagged are particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies spanning oral, injectable, inhalable, and transdermal dosage forms; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies; and the application of Quality by Design and Process Analytical Technology, known respectively as QbD and PAT, in formulation and manufacturing. Taken together, the list reads less like a call for papers and more like a map of the entire modern drug product development pipeline.

To understand why these topics matter, consider what happens when a poorly soluble drug is swallowed. For the drug to be absorbed, it must first dissolve in the fluids of the digestive tract. Dissolution rate depends heavily on surface area, and surface area depends on particle size. Reducing particles from the micrometer scale to the nanometer scale can increase surface area by orders of magnitude, dramatically accelerating dissolution. This is the principle behind nanocrystal formulations, several of which have reached the market as oral products for drugs that would otherwise have failed. Techniques such as wet milling, high-pressure homogenization, and controlled antisolvent precipitation are used to generate these tiny particles, and stabilizing them against aggregation requires careful selection of surfactants and polymeric stabilizers, a classic formulation science problem.

Particle engineering extends well beyond size reduction. Many drugs crystallize in more than one solid form, a phenomenon called polymorphism, and different polymorphs can differ in solubility, melting point, physical stability, and even manufacturability. An even more dramatic transformation is converting a crystalline drug into an amorphous solid dispersion, in which the molecule is trapped in a glassy matrix with no ordered crystal lattice at all. Because no energy is needed to break the crystal lattice, amorphous forms can achieve what researchers call supersaturation, dissolving at concentrations far above the crystalline solubility limit. The catch is that amorphous materials are thermodynamically driven to recrystallize, sometimes during storage, which can silently destroy the product’s performance. Detecting and controlling such changes requires the solid-state characterization methods highlighted in the special issue, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic techniques that can detect trace crystallinity.

The route of administration adds another layer of complexity. Inhaled medicines, for example, must deliver particles of a very specific aerodynamic diameter, typically in the range of one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. Achieving that window demands precise control of particle size, shape, and density, often through spray drying or engineered crystallization. Transdermal systems must push molecules through the skin’s outermost barrier, the stratum corneum, which requires either potent molecules, chemical penetration enhancers, or physical approaches. Injectable formulations face their own constraints: they must be sterile, isotonic, free of visible particles, and stable enough to survive storage without degrading into impurities. Each route imposes a distinct set of physical and chemical demands, which is why the special issue explicitly spans oral, injectable, inhalable, and transdermal platforms alongside advanced drug delivery systems.

Perhaps the most consequential theme in the announcement is translation, the movement of a formulation from the research bench to the manufacturing plant and ultimately to the clinic. A nanoparticle suspension that performs beautifully in a beaker may be impossible to reproduce at industrial scale, where mixing patterns, drying rates, and heat transfer behave very differently. Scale-up failures are among the most expensive problems in pharmaceutical development, capable of delaying a product launch by years. Translational formulation science addresses this by designing processes with manufacturability in mind from the start, and by using modeling and small-scale high-throughput experiments to predict how a process will behave when volumes increase a thousandfold. Emerging manufacturing technologies, from continuous manufacturing lines to advanced drying and granulation methods, are reshaping what is possible in commercial production.

The special issue’s emphasis on Quality by Design and Process Analytical Technology signals how regulatory expectations have transformed this landscape. QbD is a paradigm in which product and process development begins by defining the quality attributes that matter to patients, then systematically identifying the formulation variables and process parameters that control them, building a scientific understanding rather than relying on end-product testing alone. PAT complements this by embedding real-time sensors, such as near-infrared spectroscopy and Raman spectroscopy, directly into manufacturing equipment, allowing operators to monitor critical quality attributes as the process runs and to adjust conditions on the fly. Regulators in the United States, Europe, and elsewhere have encouraged these approaches because they promise more consistently reliable medicines and more flexible manufacturing. For researchers submitting to the special issue, demonstrating QbD and PAT integration is increasingly a prerequisite for work that aims at real-world application.

The Korean editorial team brings substantial academic weight to the project. Sung-Joo Hwang of Yonsei University has a long record in pharmaceutical formulation and drug delivery research, while Min-Soo Kim of Pusan National University is known for work on particle engineering and pharmaceutical manufacturing technologies, and Heejun Park of Duksung Women’s University contributes expertise in formulation and drug delivery systems. Their combined perspective, spanning fundamental particle science through to regulatory and translational considerations, mirrors the breadth of topics the issue is designed to cover. The Journal of Pharmaceutical Investigation, published by Springer, serves as an international forum for pharmaceutical formulation and drug delivery research, making it a natural venue for an issue intended to bridge academic innovation and industrial practice.

For the broader scientific community, the significance of this initiative lies in its timing. The pharmaceutical industry is simultaneously confronting an abundance of poorly soluble molecules from new modalities, growing interest in biologics and complex delivery systems, and pressure to modernize manufacturing with continuous and digitally monitored processes. Particle engineering and formulation science sit at the intersection of all three pressures. By consolidating advances across solubility enhancement, solid-state control, novel dosage forms, scale-up science, and quality-by-design methodology in a single collection, the January 2027 special issue aims to give researchers and developers a consolidated view of how laboratory innovations become medicines on pharmacy shelves. With submissions open until June 30, 2026, the editors are inviting contributions from academia and industry alike, in a field where the distance between a powder and a cure is measured in particles, crystals, and processes.

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

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, amorphous solid dispersions, nanocrystals, dosage forms, drug solubility