Particle Engineering and Formulation Science Drive the Next Generation of Drug Delivery

Pharmaceutical scientists are gearing up for a landmark collection of research that could reshape how medicines are designed, manufactured, and delivered to patients. The Journal of Pharmaceutical Investigation has announced a special issue devoted to translational advances in pharmaceutical dosage form development built on particle engineering and formulation science, scheduled for publication in January 2027. Led by three guest editors from leading Korean institutions, the issue aims to gather cutting-edge work that bridges the persistent gap between laboratory innovation and commercially viable drug products. With a submission deadline of June 30, 2026, the editorial team is soliciting contributions that span the full arc of dosage form development, from molecular-level solid-state control to industrial-scale manufacturing technologies.

The announcement arrives at a moment when the pharmaceutical industry faces mounting pressure to deliver therapies for increasingly difficult molecules. A large proportion of new chemical entities emerging from discovery pipelines are poorly soluble in water, which severely limits their oral absorption and therapeutic effectiveness. Particle engineering has become one of the most powerful responses to this challenge. By manipulating particle size, shape, morphology, and surface properties, scientists can dramatically alter how a drug dissolves in the gastrointestinal tract, how stable it remains on the shelf, and how readily it reaches systemic circulation. Techniques such as micronization, nanosizing, spray drying, supercritical fluid processing, and hot-melt extrusion each offer distinct routes to overcoming solubility barriers, and the special issue explicitly calls for papers that advance these approaches for solubility, stability, and bioavailability enhancement.

Guest editors Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University bring complementary expertise spanning pharmaceutics, formulation technology, and drug delivery systems. Their stated vision for the issue emphasizes translation, a word that carries substantial weight in pharmaceutical research. Many elegant particle-engineering strategies demonstrated at bench scale never survive contact with the realities of Good Manufacturing Practice, regulatory scrutiny, and cost constraints. Translational formulation science, as the editors frame it, demands that researchers think beyond proof-of-concept experiments and consider how a formulation will behave during scale-up, how it will be characterized by quality control laboratories, and how it will perform consistently across production batches distributed to millions of patients.

The scope of the issue covers advanced formulation strategies for essentially every major route of administration. Oral dosage forms remain the dominant category, and innovations in tablets, capsules, and orally disintegrating formats continue to rely heavily on particle science. Yet the call for papers extends equally to injectable formulations, where submicron suspensions and amorphous solid dispersions can extend the action of drugs over weeks or months, and to inhalable medicines, where aerodynamic particle diameter in the range of one to five microns determines whether an active ingredient deposits in the lungs or is exhaled away. Transdermal systems, which push drugs through the skin’s formidable barrier, and other advanced drug delivery platforms are also within scope, reflecting a recognition that particle and formulation principles underpin delivery science across every route.

One of the most technically demanding topics on the editors’ list is solid-state characterization and control. The physical form of a drug substance, whether crystalline, amorphous, or a mixture of polymorphic states, governs its dissolution rate, physical stability, and even its propensity to convert to a less desirable form during storage. Amorphous solid dispersions, in which a drug is molecularly dispersed in a polymer matrix to maintain a high-energy state, offer solubility gains of orders of magnitude but carry inherent recrystallization risks. Characterizing such systems requires an arsenal of analytical techniques, including differential scanning calorimetry, powder X-ray diffraction, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy. The special issue invites work that strengthens the ability of formulators to not only detect these solid-state transformations but to predict and prevent them, a capability that directly affects product shelf life and regulatory approval.

Scale-up represents another central theme, and arguably the one where most translational projects falter. A spray-drying process that yields beautiful amorphous particles on a laboratory bench may produce agglomerated, inconsistent material when the same parameters are applied to a commercial-scale dryer with different heat and mass transfer characteristics. Wet granulation, fluid-bed coating, and high-shear mixing all exhibit similar sensitivities to equipment geometry and processing conditions. Papers addressing translational formulation science and scale-up of drug products will therefore be of intense interest to industry scientists who must transfer processes from development facilities to manufacturing sites, often across continents, while demonstrating that critical quality attributes remain within tight specification limits throughout the change.

Emerging manufacturing technologies constitute a further pillar of the issue’s scope, encompassing continuous manufacturing, additive approaches, and other innovations in dosage form design and commercial production. The pharmaceutical industry has historically relied on batch processing, in which materials move between discrete unit operations with extensive testing at each step. Continuous manufacturing, by contrast, feeds raw materials through an integrated train of operations that can run for days, offering tighter process control, smaller facility footprints, and faster response to demand. Fused deposition modeling and other printing technologies have opened possibilities for personalized dosing, particularly valuable in pediatrics and for potent compounds requiring highly individualized strengths. Work that carries these technologies toward commercial production aligns squarely with the issue’s translational mandate.

Quality by Design and Process Analytical Technology, familiar acronyms to anyone in pharmaceutical development, also feature prominently in the call for papers. Quality by Design inverts the traditional approach to product development: rather than testing finished batches and rejecting failures, developers systematically identify the material attributes and process parameters that critically affect product quality, then build controls around them. Process Analytical Technology supplies the real-time measurement tools, near-infrared spectroscopy, Raman spectroscopy, and inline particle size analysis among them, that make such control feasible during actual production. Regulators including the United States Food and Drug Administration and the European Medicines Agency have championed these frameworks for nearly two decades, yet their implementation remains uneven across the industry, and contributions that demonstrate practical QbD and PAT applications in formulation and manufacturing will address a genuine need.

The significance of an issue like this extends well beyond the academic community that will contribute to it. For patients, advances in particle engineering translate into medicines that dissolve reliably, remain potent for years, and can be formulated into convenient once-daily regimens rather than burdensome multiple-dose schedules. For the biopharmaceutical industry, robust formulation science determines whether a promising molecule can even reach the market, since an estimated large share of pipeline candidates fail in development not because of their biology but because they cannot be formulated into stable, manufacturable, patient-acceptable products. For regulatory agencies, the analytical and process-control advances showcased in translational research provide the technical foundation for modern quality standards and streamlined review pathways.

Researchers intending to contribute have until June 30, 2026 to submit their manuscripts, with the completed issue expected in January 2027. That timeline positions the collection to capture some of the most current thinking in a field that is evolving rapidly under the combined pressures of increasingly complex drug molecules, sustainability demands in manufacturing, and the rise of biologics that require their own formulation innovations. By gathering solubility enhancement strategies, solid-state science, scale-up experience, emerging manufacturing platforms, and quality frameworks into a single curated volume, the guest editors aim to provide both a snapshot and a roadmap of where pharmaceutical dosage form development is heading. For a discipline in which the difference between a molecule’s success and failure often hinges on the behavior of particles far too small to see, that roadmap could prove invaluable to scientists working at every stage of the journey from discovery bench to pharmacy shelf.

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

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Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, bioavailability, solid-state characterization, scale-up, Quality by Design, Process Analytical Technology, continuous manufacturing, pharmaceutical dosage forms, Journal of Pharmaceutical Investigation