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

A major new special issue of the Journal of Pharmaceutical Investigation is set to gather the latest translational research in pharmaceutical dosage form development, with a focus on how particle engineering and formulation science can move laboratory innovations into medicines that patients actually take. 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 led 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. Together they are inviting contributions that span the full journey of a drug product, from the first manipulation of particles at the micrometer and nanometer scale to the scaled-up manufacturing lines that produce billions of tablets, capsules, and injectable vials each year.

The emphasis on translation is what sets this call apart from many formulation-focused collections. In modern pharmaceutics, a molecule that shows promise in a discovery lab often fails not because it lacks pharmacological activity but because it cannot be delivered. Poor aqueous solubility, physical instability, rapid clearance, and manufacturing bottlenecks routinely derail development candidates. Particle engineering attacks these problems at their physical root. By controlling crystal form, particle size distribution, surface morphology, and solid-state properties, scientists can dramatically alter how a drug dissolves, how it is absorbed, and how it behaves on a production line. The special issue explicitly targets these approaches, asking researchers to submit work on particle engineering strategies that enhance solubility, stability, and bioavailability, the three properties that most often determine whether a formulation survives the journey from bench to bedside.

The technical logic behind particle engineering rests on a well-established principle: dissolution rate scales with surface area. Reducing the size of drug particles from the micrometer range into the nanometer range multiplies the surface area available for contact with dissolution media, which can raise apparent solubility and speed absorption, particularly for Biopharmaceutics Classification System class II compounds that are soluble in neither water nor lipids. Techniques such as wet media milling, high-pressure homogenization, spray drying, supercritical fluid processing, and antisolvent crystallization each offer distinct advantages in controlling particle size and morphology. Spray drying, for example, converts a drug solution or suspension into dry amorphous or crystalline particles in a single continuous step, allowing formulators to lock a drug into a high-energy amorphous state stabilized by polymeric carriers. The trade-off is that amorphous solids carry a thermodynamic drive to recrystallize, so stabilizing them over a product’s shelf life demands careful selection of polymers, moisture barriers, and storage conditions.

Crystal form itself is equally consequential. Polymorphism, the ability of a molecule to pack into more than one crystal structure, means that the same chemical entity can exist as several solids with different melting points, dissolution rates, and stability profiles. Regulators require manufacturers to identify and control the intended solid form, because an unintended transformation during processing or storage can change a medicine’s performance. This is why the special issue dedicates a topic area to solid-state characterization and control. Modern analytical toolkits combine powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, Raman and infrared spectroscopy, and solid-state nuclear magnetic resonance to fingerprint crystal lattices and detect trace amounts of unwanted forms. Computational crystal structure prediction is increasingly used alongside these experiments to flag risky molecules early, giving development teams a head start on selecting forms that balance manufacturability with bioavailability.

Beyond the solid state, the call invites advanced formulation strategies across an unusually broad range of delivery routes: oral, injectable, inhalable, transdermal, and other dosage forms, together with advanced drug delivery systems. Each route imposes its own engineering constraints. Oral products must survive gastric acid and enzymatic attack before releasing their payload in the intestine, which has driven the development of enteric coatings, pH-responsive polymers, and amorphous solid dispersions. Injectable formulations must be sterile, isotonic, and free of particles that could trigger embolism or immune reactions, pushing formulators toward nanosuspensions, liposomes, and polymeric micelles that can carry poorly soluble drugs in biocompatible carriers. Inhalable medicines must generate aerosol droplets or dry powder particles in a narrow aerodynamic diameter range, typically one to five micrometers, so that they deposit in the deep lung rather than the throat, a requirement that has made particle engineering indispensable for respiratory products such as inhaled corticosteroids and dry powder antibiotics.

Transdermal and long-acting injectable systems illustrate how formulation science can reshape treatment paradigms rather than merely deliver molecules. Transdermal patches rely on drug molecules crossing the stratum corneum, the skin’s outermost barrier, which favors small, moderately lipophilic compounds and has inspired chemical penetration enhancers, microneedle arrays, and iontophoretic devices that actively drive drugs through the skin. Long-acting injectable suspensions and implants, built from engineered microspheres or in-situ forming depots, can release a drug over weeks or months, improving adherence in conditions such as schizophrenia, diabetes, and HIV where daily dosing is a burden. The special issue’s inclusion of these systems signals an interest in work that demonstrates real clinical or commercial translation, not just proof-of-concept experiments in glassware.

Scale-up is another pillar of the call, and it is where many elegant laboratory formulations meet their hardest test. A process that works in a one-liter beaker may behave very differently in a two-hundred-liter spray dryer or a high-shear granulator the size of a small car. Mixing efficiency, heat transfer, drying kinetics, and shear forces all change with scale, and a formulation tuned at laboratory scale can lose its dissolution advantage or crystallize unexpectedly when produced in bulk. Translational formulation science therefore involves designing processes that are robust to these shifts, using scaled-down models that faithfully predict large-scale behavior, and building in tolerances that keep the product within its quality specifications across batches. Contributions on scale-up of drug products are explicitly welcomed, reflecting a recognition that the gap between a publishable formulation and a registrable manufacturing process remains one of the field’s most persistent challenges.

Emerging manufacturing technologies form a closely related theme. Continuous manufacturing, in which powder feeding, blending, granulation, drying, and tableting proceed as an uninterrupted flow rather than discrete batch steps, is steadily gaining regulatory acceptance because it enables real-time quality control and smaller facility footprints. Additive manufacturing, best known through three-dimensional printing, has already produced a regulated oral product with a highly porous, rapidly disintegrating structure, and it opens the door to personalized doses printed on demand. Hot-melt extrusion, electrospinning, microfluidic nanoparticle production, and supercritical antisolvent precipitation each give formulators new levers over particle attributes that were previously inaccessible. The special issue invites work on these technologies in dosage form design and commercial production, a phrasing that underscores the expectation that papers should address not only feasibility but also the practicalities of throughput, reproducibility, and regulatory compliance.

Woven through all six topic areas is the framework of Quality by Design and Process Analytical Technology, two paradigms that have redefined how pharmaceutical development and manufacturing are conducted. Quality by Design asks developers to define the quality target product profile up front, identify the critical material attributes and critical process parameters that govern it, and build a design space within which the product reliably meets its specifications. Process Analytical Technology supplies the sensors that make this possible in real time: near-infrared probes that track blend uniformity inside a granulator, Raman spectroscopy that monitors polymorphic form during drying, and laser diffraction instruments that watch particle size distributions as they evolve. Together these approaches replace end-product testing with continuous understanding, allowing manufacturers to adjust processes on the fly and giving regulators a scientific basis for flexible operations. Submissions applying QbD and PAT to formulation and manufacturing are a stated priority of the issue.

For researchers working anywhere along this continuum, the special issue represents a consolidated opportunity to place particle and formulation science in its translational context. The guest editors, drawing on their institutions’ long records in drug delivery and pharmaceutical engineering, are positioning the collection as a snapshot of where dosage form development stands as it absorbs continuous manufacturing, computational materials science, and increasingly demanding regulatory expectations. With submissions due by June 30, 2026 and publication planned for January 2027, the timeline is designed to capture work that is mature enough to demonstrate real-world relevance. For a discipline whose successes are often invisible, embedded in the dissolution profile of a generic tablet or the aerosol plume of an inhaler, the issue offers something valuable: a platform to show how the physics of tiny particles determines whether breakthrough molecules become dependable medicines.

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, continuous manufacturing, amorphous solid dispersions, scale-up, pharmaceutical manufacturing, Journal of Pharmaceutical Investigation