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

Particle engineering has quietly become one of the most consequential disciplines in modern pharmaceutics, and a forthcoming special issue of the Journal of Pharmaceutical Investigation aims to capture exactly how laboratory-scale advances in this field are being translated into real dosage forms that 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 guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three Korean pharmaceutical scientists whose combined expertise spans formulation design, particle technology, and the industrial realities of moving a drug product from bench to market.

The premise behind the special issue is straightforward but ambitious: many of today’s most promising drug molecules fail not because they lack pharmacological activity, but because they cannot be formulated into products that dissolve, stabilize, and reach their targets in the body. Poorly water-soluble compounds now dominate discovery pipelines, and the gap between a molecule’s intrinsic potency and its clinical performance is frequently a formulation problem. Particle engineering, the deliberate manipulation of particle size, shape, morphology, and solid-state form, offers a toolkit for closing that gap. Techniques such as micronization, nanosizing, spray drying, hot-melt extrusion, and controlled crystallization can transform an intractable compound into a powder with the dissolution profile, flow properties, and physical stability needed for a viable tablet, capsule, inhaler, or injectable suspension.

The scope of the issue, as outlined by the editors, covers six broad thematic areas. The first is particle engineering approaches for enhancing solubility, stability, and bioavailability, which sits at the heart of the bioavailability crisis in drug development. Reducing particle size increases the surface area available for dissolution, and when particles are pushed into the nanometer range, additional phenomena such as increased saturation solubility and improved adhesion to biological membranes come into play. Amorphous solid dispersions, in which a crystalline drug is molecularly dispersed in a polymer matrix, represent another cornerstone strategy, trading the thermodynamic stability of the crystal lattice for dramatically faster dissolution, at the cost of requiring careful control of recrystallization risk over a product’s shelf life.

A second thematic pillar concerns advanced formulation strategies across the full spectrum of dosage routes, including oral, injectable, inhalable, and transdermal delivery, along with broader advanced drug delivery systems. Each route imposes its own particle-level demands. Inhaled medicines, for example, require particles in a narrow aerodynamic size range, typically around one to five micrometers, to deposit in the deep lung rather than being exhaled or trapped in the throat. Dry powder inhalers depend on engineered particle surfaces and carrier interactions to achieve reproducible dispersion upon inhalation. Injectable suspensions demand particles that are small and uniform enough to pass through fine needles without clogging while remaining physically stable in suspension over months of storage. Transdermal systems, meanwhile, must balance drug loading with the permeability constraints of the stratum corneum, often relying on particle-based carriers or crystallinity control to maintain a stable thermodynamic driving force for skin penetration.

Solid-state characterization and control form the third focus area, and they represent the analytical backbone of everything else in the issue. The same molecule can exist in multiple crystalline forms, known as polymorphs, each with distinct solubility, melting point, mechanical behavior, and stability characteristics. The infamous case of ritonavir, an HIV drug whose market product failed in the late 1990s when a previously unknown, far less soluble polymorph spontaneously appeared during manufacturing, remains a defining cautionary tale for the industry. Modern pharmaceutical science responds with a battery of techniques, including powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance, to identify, quantify, and monitor the solid forms present in a drug product. The special issue invites contributions on how such characterization can be used not merely descriptively but predictively, guiding formulators toward solid states and processing conditions that will remain stable from first clinical batch to final commercial lot.

The fourth theme, translational formulation science and scale-up, addresses what many researchers consider the most difficult step in the entire pipeline. A formulation that performs beautifully in a one-liter beaker may behave entirely differently in a thousand-liter high-shear granulator. Scale-up introduces changes in mixing dynamics, heat transfer, drying rates, and mechanical stress that can alter particle size distributions, polymorphic outcomes, and blend uniformity. Translational formulation science seeks to understand and anticipate these shifts, building in vitro and in silico models that predict how a process will behave at production scale before expensive equipment is committed. The editors’ emphasis on translation signals a deliberate editorial preference for work that demonstrates this kind of industrial relevance, rather than purely mechanistic studies that stop at the laboratory bench.

Emerging manufacturing technologies constitute the fifth pillar, and this is where the field is arguably changing fastest. Continuous manufacturing, in which drug product is produced in a flowing integrated line rather than in discrete batch steps, is gaining regulatory and industrial acceptance because it enables real-time quality control and more flexible production volumes. Additive manufacturing, most prominently three-dimensional printing, has already produced the first FDA-approved printed medicine, a rapidly disintegrating levetiracetam tablet whose highly porous structure was made possible only by the printing process. Other emerging approaches include electrospinning for nanofiber drug matrices, supercritical fluid technologies for producing solvent-free engineered particles, and hot-melt extrusion lines capable of continuous amorphous dispersion production. Each of these technologies reshapes what particle and dosage form designers can achieve, and each brings its own scale-up and regulatory questions.

The sixth theme, Quality by Design and Process Analytical Technology, provides the regulatory and methodological framework that ties the others together. Quality by Design, or QbD, is a paradigm in which product and process understanding is built systematically into development: instead of testing quality into a finished product, manufacturers design the formulation and process so that critical quality attributes are controlled by understood relationships between input materials and process parameters. Process Analytical Technology, or PAT, supplies the real-time sensing tools, such as near-infrared spectroscopy, Raman spectroscopy, and focused beam reflectance measurement, that make this control possible on the factory floor. Together, QbD and PAT allow particle properties to be monitored and adjusted during production rather than discovered afterward in quality control testing, a shift with profound implications for both efficiency and patient safety.

For researchers considering submission, the June 30, 2026 deadline places the issue roughly a year and a half out, a timeline that accommodates both completed studies and work currently in progress. The guest editors’ institutional affiliations reflect the strength of South Korea’s pharmaceutical formulation research community, which has produced significant contributions in areas such as amorphous formulations, nanocrystal technology, and orally disintegrating dosage forms. The Journal of Pharmaceutical Investigation, published by Springer, serves as a venue where Asian and international pharmaceutical science converge, and a special issue of this scope is likely to draw contributions from academic groups, generic and innovative drug manufacturers, and contract development organizations alike.

The broader significance of the initiative lies in its insistence that particle engineering and formulation science are not peripheral support disciplines but central drivers of translational medicine. As biologics, poorly soluble small molecules, and combination products increasingly dominate therapeutic pipelines, the ability to engineer particles and design robust formulations determines whether scientific discoveries ever reach patients. By soliciting work that spans the full arc from particle design through solid-state control, scale-up, emerging manufacturing, and regulatory quality frameworks, the special issue is positioning formulation science where it increasingly belongs in practice: at the center of drug product development, with a direct line of sight from the crystallization vessel to the clinic.

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, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solid dispersions, scale-up, pharmaceutical manufacturing, Journal of Pharmaceutical Investigation