Particle Engineering Takes Center Stage as Pharmaceutical 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, and its scope signals where the field is heading. Titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, the issue will be published in January 2027, with a submission deadline of June 30, 2026. Three guest editors from South Korea are steering the effort: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Together they represent a research community that has spent years trying to answer a deceptively simple question: how do you turn a molecule that works in a laboratory into a medicine that dissolves, travels, and performs reliably inside a patient?

The answer, increasingly, lies at the scale of particles. Many of the most promising drug candidates discovered in recent decades are poorly soluble in water, which means they can pass through a manufacturing plant and a clinical trial while delivering only a fraction of their intended dose to the bloodstream. Particle engineering attacks this problem directly by manipulating crystal form, particle size, surface properties, and morphology to change how a drug behaves in the body. Techniques such as micronization, nanocrystal formation, spray drying, hot-melt extrusion, and controlled crystallization can transform a stubborn molecule into a formulation that dissolves quickly and consistently. The special issue explicitly invites work on particle engineering approaches for solubility, stability, and bioavailability enhancement, placing these methods at the heart of translational drug development.

Why does this matter so much now? The pharmaceutical pipeline is dominated by molecules that would have been abandoned a generation ago. Poorly soluble compounds account for a large share of new chemical entities, and biologics, peptides, and other complex molecules bring their own delivery challenges. A drug that cannot be formulated into a stable, manufacturable, patient-acceptable dosage form never reaches the pharmacy shelf, no matter how elegant its mechanism of action. Formulation science is therefore not an afterthought to drug discovery; it is often the decisive step that determines whether a discovery becomes a therapy. The special issue’s emphasis on translational advances reflects a growing recognition that the gap between bench and bedside is frequently a formulation gap.

The scope of the call for papers is deliberately broad, covering advanced formulation strategies for oral, injectable, inhalable, transdermal, and other dosage forms, as well as advanced drug delivery systems. Each of these routes presents distinct technical demands. Oral formulations must survive the acidic environment of the stomach and release their payload at the right point in the digestive tract. Injectable products must be sterile, stable in solution or suspension, and tolerable at the injection site. Inhaled medicines depend on aerodynamic particle size distributions measured in micrometers to deposit drug in the lungs rather than the throat. Transdermal systems must push molecules through a skin barrier that evolved to keep things out. Advances in one route often inspire progress in another, which is why the editors have chosen to frame the issue around shared principles of particle and formulation science rather than around any single delivery technology.

Solid-state characterization and control form another pillar of the issue. The same drug molecule can exist in multiple crystalline forms, known as polymorphs, each with different solubility, stability, and manufacturing behavior. A famous cautionary tale is ritonavir, an HIV drug that suddenly converted to a less soluble polymorph during manufacturing in the late 1990s, forcing a market withdrawal until the problem was solved. Modern pharmaceutical development therefore treats solid-state analysis as a core discipline, using techniques such as X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic methods to identify, select, and monitor the physical form of a drug throughout its lifecycle. Papers that advance the ability to predict, detect, and control such transformations are squarely within the issue’s remit.

Scale-up is where many promising formulations stumble, and the special issue addresses this head-on through its focus on translational formulation science and the scale-up of drug products. A process that works beautifully with grams of material in a laboratory may behave very differently with hundreds of kilograms in a factory. Mixing dynamics, drying rates, temperature gradients, and shear forces all change with scale, and subtle shifts can alter particle size distributions or crystal forms in ways that affect the final product. Translational formulation science aims to anticipate these changes, designing formulations and processes that remain robust from the first laboratory batch to full commercial production. It is an area where academic research, regulatory science, and industrial engineering converge, and where the Korean formulation community has been particularly active.

Emerging manufacturing technologies represent another major theme. Continuous manufacturing, which replaces the traditional batch-by-batch model with an uninterrupted flow of material through integrated unit operations, is reshaping how dosage forms are designed and produced. Additive manufacturing, including various 3D printing approaches, allows dosage forms with customized shapes, doses, and release profiles that would be impossible with conventional tableting. These technologies compress development timelines, reduce waste, and open the door to personalized medicines in which a dose can be tailored to an individual patient. The special issue’s invitation for work on emerging manufacturing technologies in dosage form design and commercial production signals that the editors want contributions spanning the full journey from concept to market.

Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, provide the scientific and regulatory framework that ties much of this together. QbD asks developers to build quality into a product from the start, systematically identifying the critical material attributes and process parameters that determine performance, rather than testing quality in at the end. PAT supplies the real-time analytical tools, such as near-infrared spectroscopy, Raman spectroscopy, and inline particle size analysis, that make it possible to monitor and control those parameters as manufacturing happens. Together they enable continuous improvement, real-time release testing, and a deeper mechanistic understanding of formulation processes. The special issue explicitly calls for QbD and PAT applications in pharmaceutical formulation and manufacturing, underscoring how central these paradigms have become to regulatory expectations in the United States, Europe, and Asia.

The timing of the issue, arriving in early 2027 with submissions due by mid-2026, positions it to capture a wave of current research. Formulation scientists worldwide are racing to enable new modalities, from mRNA therapeutics and antibody-drug conjugates to long-acting injectables and inhaled biologics. Each of these depends on the same fundamentals the issue highlights: controlling particles, mastering physical states, and engineering processes that translate reliably to production. At the same time, the industry faces pressure to make manufacturing more sustainable, more flexible, and more resilient to supply chain disruption, all of which push innovation in formulation and process design. A dedicated venue for this work, curated by editors with deep experience in pharmaceutical development, offers researchers a chance to present integrated studies that connect molecular properties to patient outcomes.

For readers outside the field, the special issue is a reminder that medicines are engineered objects, not just molecules. The difference between a drug that fails and a drug that saves lives can come down to the size of a crystal, the choice of a polymer, or the design of a drying process. By gathering advances in particle engineering, formulation strategy, solid-state science, scale-up, manufacturing technology, and quality systems in one place, the Journal of Pharmaceutical Investigation is drawing a map of the discipline as it stands and pointing toward where it is going. Researchers interested in contributing have until June 30, 2026, to submit their work for consideration in the January 2027 issue, and the breadth of the announced topics suggests the editors expect the resulting collection to serve as a reference point for anyone working to move new therapies from the laboratory bench to the patients who need them.

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, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, dosage forms, Journal of Pharmaceutical Investigation