Particle Engineering Takes Center Stage as Pharmaceutical Formulation Science Enters Its Translational Era

Some of the most consequential breakthroughs in modern medicine never make headlines on their own. They arrive instead as quietly engineered powders, inhalable sprays, long-acting injectables, and dissolving films — the dosage forms that determine whether a promising molecule actually reaches the right place in the body at the right concentration. A new special issue of the Journal of Pharmaceutical Investigation, scheduled for publication in January 2027, is setting out to capture this often-overlooked frontier. Titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, the issue 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. Researchers have until June 30, 2026, to submit their work for consideration.

The premise behind the issue is deceptively simple: a drug molecule is only as good as the formulation that delivers it. Many of the compounds emerging from modern discovery pipelines are poorly soluble in water, chemically fragile, or difficult to absorb through biological membranes. Particle engineering — the deliberate manipulation of crystal form, particle size, shape, and surface properties — has become one of the most powerful toolkits for overcoming these barriers. By reducing particles to the nanometer scale, converting unstable crystalline forms into amorphous solids, or coating particles with functional excipients, formulation scientists can transform a molecule that would otherwise fail into a medicine that dissolves rapidly, survives storage, and reaches therapeutic concentrations in the bloodstream.

The special issue’s scope reflects how broad this field has become. Among the topics the editors have identified 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 for dosage form design and commercial production; and the application of Quality by Design and Process Analytical Technology in formulation and manufacturing. Taken together, these themes trace the full arc of pharmaceutical development — from the first manipulation of a molecule’s solid form to the validated, regulated processes that produce billions of doses a year.

That emphasis on translation is what distinguishes this collection from much of the academic literature on drug delivery. Laboratory demonstrations of novel nanoparticles and carrier systems are abundant; what remains harder is carrying those innovations through preclinical testing, clinical formulation, regulatory scrutiny, and industrial-scale manufacturing without losing the performance that made them attractive in the first place. Translational formulation science asks whether a nanosuspension that dazzles in a beaker can be milled reproducibly at industrial scale, whether an amorphous solid dispersion retains its physical stability through two years of shelf life in a humid climate, and whether an inhaled powder can be delivered consistently from a commercial device by real patients with real technique limitations.

Solid-state science sits at the heart of many of these questions. A single drug molecule can crystallize in multiple polymorphic forms, each with different solubility, melting behavior, mechanical properties, and tendency to convert into other forms over time. The infamous case of ritonavir, an HIV drug whose effective crystal form spontaneously transformed into a far less soluble polymorph in the late 1990s, forced the temporary withdrawal of the product and reshaped how the industry thinks about solid-state risk. Since then, techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance have become indispensable for characterizing and controlling the physical state of drugs. The special issue’s focus on solid-state characterization and control signals that this remains a live and evolving area, particularly as amorphous and co-amorphous systems push materials further from thermodynamic equilibrium.

Manufacturing is the other half of the translational equation. Hot-melt extrusion, spray drying, supercritical fluid processing, and cryogenic milling have each expanded the range of particle and formulation architectures that can be produced at scale, while continuous manufacturing is beginning to replace batch processes in parts of the industry. Continuous production offers tighter control, smaller footprints, and faster development cycles, but it demands real-time knowledge of what is happening inside the process. That is where Process Analytical Technology comes in: inline and online sensors — near-infrared spectroscopy, Raman spectroscopy, laser diffraction — feed continuous data into process models, allowing operators to detect and correct drift before it produces out-of-specification product. Paired with Quality by Design, the regulatory philosophy that builds quality into a product through systematic understanding of formulation and process variables rather than testing it in afterward, PAT has reshaped how drug products are developed and approved.

The breadth of delivery routes covered by the issue also mirrors changing therapeutic needs. Oral solid dosage forms still dominate the market, but biologics, vaccines, and personalized therapies are driving growth in injectables, including long-acting depot formulations that release drugs over weeks or months. Inhalable formulations have moved from the margins of asthma care to the center of attention during respiratory disease outbreaks, and transdermal systems are expanding as a route for drugs that degrade in the gut or burden the liver. Each route imposes its own particle engineering demands: aerodynamic diameter windows for lung deposition, syringeability and suspension stability for injectables, adhesion and permeation properties for skin delivery. A formulation scientist today must be as fluent in biopharmaceutics and device interaction as in crystallography and rheology.

For the research community, the special issue represents an opportunity to consolidate a decade of rapid progress. The COVID-19 pandemic demonstrated both the power and the fragility of global pharmaceutical manufacturing, and it accelerated interest in formulation technologies that improve thermal stability, enable dose sparing, and simplify distribution. Meanwhile, the rising proportion of poorly soluble molecules in development pipelines keeps solubility enhancement at the top of the industry’s technical agenda, and the growth of biologics raises new questions about stabilizing proteins, peptides, and nucleic acids in formats patients can actually use. Work that bridges these scientific advances with the practical realities of scale-up, regulation, and commercial production is precisely what the guest editors have asked contributors to address.

The timeline is deliberately structured to support that goal. With submissions due by the end of June 2026 and publication planned for January 2027, the issue is positioned to capture work that is maturing now — including advances in artificial intelligence-assisted formulation design, high-throughput solid-state screening, and digital twins of manufacturing processes that are moving from concept papers into industrial practice. The editors, who bring combined expertise spanning drug delivery systems, pharmaceutical manufacturing, and formulation development from their institutions in Seoul, Busan, and Seoul respectively, have framed the call around translational impact rather than novelty alone, a criterion that favors studies demonstrating reproducibility, scalability, and real-world relevance.

For patients, the stakes of this seemingly technical field are concrete. A better-engineered particle can mean a pill that works at half the dose, an injectable that replaces a daily injection with one every three months, an inhaler that delivers more drug to the lungs and less to the throat, or a vaccine that survives transport without a cold chain. Formulation science is where molecular promise becomes clinical reality, and the Journal of Pharmaceutical Investigation’s 2027 special issue is an attempt to map how that conversion is being engineered, controlled, and scaled. As the submission window opens toward its June 2026 deadline, the collection promises a snapshot of a discipline quietly deciding how — and how well — the next generation of medicines will actually reach the people 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

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, Journal of Pharmaceutical Investigation, special issue