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

A new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation, with a focus on how particle engineering and formulation science are transforming laboratory discoveries into medicines patients can actually use. 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 guided 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.

The announcement may look like routine academic housekeeping, but the subject matter sits at one of the most critical bottlenecks in the pharmaceutical industry. A striking proportion of drug candidates emerging from discovery pipelines today are poorly soluble in water, which means they dissolve poorly in the gastrointestinal tract and reach the bloodstream in amounts too small to be therapeutically effective. Estimates across the industry consistently suggest that a large share of new chemical entities, and an even larger share of compounds in development pipelines, fall into this poorly soluble category. Particle engineering, the deliberate manipulation of crystal form, particle size, shape, and surface properties, has become one of the most powerful toolkits for rescuing these molecules.

The special issue explicitly invites contributions on particle engineering approaches for enhancing solubility, stability, and bioavailability. In practice, this covers a remarkable range of technologies. Micronization and nanonization reduce particle size to increase surface area and accelerate dissolution. Amorphous solid dispersions trap drug molecules in a disordered, high-energy state that dissolves far more readily than the crystalline form, though this comes with the persistent challenge of preventing the drug from reverting to its stable crystal over a product’s shelf life. Co-crystals, in which the drug molecule is paired with a benign co-former in a new crystal lattice, offer another route to improved properties without abandoning crystallinity altogether.

Each of these strategies involves trade-offs that formulation scientists must navigate with considerable precision. Nanocrystals, for example, offer dramatic gains in dissolution rate, but their high surface energy makes them prone to aggregation, requiring stabilizers and careful control of the manufacturing process. Amorphous dispersions can crystallize during storage, particularly in humid conditions, so formulators must understand the molecular mobility of the system and design packaging and storage conditions accordingly. Solid-state characterization, another topic highlighted in the call for papers, is the discipline that makes this possible: techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic methods allow scientists to determine exactly which physical form of a drug is present and how it behaves under stress.

The scope of the issue extends well beyond oral tablets. The editors call for advanced formulation strategies across oral, injectable, inhalable, and transdermal dosage forms, as well as broader advanced drug delivery systems. Each route of administration imposes its own demanding constraints. Inhaled medicines must produce particles in a narrow aerodynamic size range, typically around one to five micrometers, to deposit in the lungs rather than the throat or exhaled air. Injectable formulations must be sterile, isotonic, and free of particles that could cause harm, while biologics add further complexity because proteins can unfold or aggregate under stresses that small molecules would shrug off. Transdermal systems must push drugs through the skin’s formidable barrier layer, often relying on chemical enhancers, microneedles, or engineered particle systems.

One of the most distinctive emphases of the special issue is translation, the movement of a formulation from the bench to manufactured, regulated, commercially viable drug product. Translational formulation science and scale-up form a dedicated topic in the call for papers, reflecting a hard truth of the industry: a formulation that performs brilliantly in a laboratory beaker may fail spectacularly when produced at industrial scale. Mixing dynamics, drying behavior, flow properties of powders, and the sensitivity of processes to small changes in temperature, humidity, or raw material lots can all shift as equipment grows from grams to tons. A formulation designed with manufacturability in mind from the outset is far more likely to survive this journey.

Emerging manufacturing technologies receive their own section in the issue’s scope, and this is where some of the most visible recent innovation has occurred. Continuous manufacturing, which replaces the traditional batch process with a steady flow of material through connected unit operations, offers tighter control and faster response to demand. Hot-melt extrusion, in which drug and polymer are melted and mixed together, has become a mainstay for producing amorphous dispersions. Additive manufacturing, better known as 3D printing, has produced the first approved printed drug product and opens the door to dosage forms with complex internal geometries or personalized doses. Electrospinning, spray drying, and supercritical fluid technologies each provide distinct ways of engineering particles with tailored morphology and release behavior.

Alongside these technologies, the issue highlights Quality by Design and Process Analytical Technology, two regulatory and scientific frameworks that have reshaped how drug products are developed and controlled. Quality by Design asks developers to build scientific understanding into the process itself, systematically identifying the parameters that matter and demonstrating how they control the final product’s quality, rather than relying on end-product testing alone. Process Analytical Technology supplies the real-time sensors, such as near-infrared spectroscopy and Raman spectroscopy, that make this possible, allowing manufacturers to monitor blend uniformity, granulation endpoints, and drying progress as they happen. Together, these approaches support a shift toward continuous, adaptive manufacturing and, ultimately, more reliable medicines.

The timing of the special issue reflects broader pressures on the field. The rise of biologics, antibody-drug conjugates, RNA therapeutics, and mRNA platforms has expanded the definition of what a dosage form must do, while small-molecule pipelines continue to deliver increasingly insoluble and potent compounds. At the same time, regulators and health systems are pushing for patient-centered formulations, including orally disintegrating tablets, fixed-dose combinations, and long-acting injectables that improve adherence. Formulation scientists now sit at the intersection of chemistry, engineering, materials science, and regulatory policy, and the ability to design particles and dosage forms with intention has become a genuine competitive advantage for companies and a lifeline for drug candidates that would otherwise fail.

For researchers, the call for papers represents an opportunity to contribute to a conversation that is explicitly translational in orientation. The guest editors, drawing on institutional expertise spanning academic pharmaceutics and formulation development, are seeking work that does not stop at proof of concept but demonstrates a credible path toward drug product. Submissions are due by June 30, 2026, ahead of the January 2027 publication date. As the pharmaceutical industry confronts an era of difficult molecules and demanding patients, the humble particle, engineered with precision and understood in depth, is proving to be one of the most important units of medical progress, and this special issue aims to chart exactly how far that progress has come and where it is headed next.

Subject of Research: Particle engineering and formulation science in pharmaceutical dosage form development

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, amorphous solid dispersions, solid-state characterization, Quality by Design, Process Analytical Technology, continuous manufacturing, scale-up, dosage forms, Journal of Pharmaceutical Investigation