The premise behind the special issue reflects a quiet but profound shift in how the pharmaceutical industry thinks about the medicines it produces. For decades, the discovery of a new molecule was treated as the decisive step in drug development, with formulation relegated to a downstream technical exercise. That view has eroded. A growing share of pipeline compounds, particularly the lipophilic small molecules that dominate modern medicinal chemistry, exhibit solubility so poor that their therapeutic potential cannot be realized through conventional tableting or capsule filling. Estimates across the industry suggest that a large fraction of newly synthesized drug candidates fall into the poorly water-soluble category, and this is precisely where particle engineering has become indispensable. By manipulating crystal form, particle size, morphology, and surface properties, formulators can transform a molecule that dissolves too slowly to be absorbed into one with clinically meaningful bioavailability.

The topics outlined for the special issue map directly onto this challenge. Particle engineering approaches for solubility, stability, and bioavailability enhancement sit at the top of the list, and the techniques involved are remarkably diverse. Micronization and nanonization reduce particle dimensions to increase the surface area available for dissolution, following the Noyes-Whitney relationship that links dissolution rate to surface area. Amorphous solid dispersion takes a different route, trapping a drug molecule in a disordered, high-energy glassy matrix that dissolves faster than its crystalline counterpart, though at the cost of a persistent risk that the drug will recrystallize during storage. Co-crystal engineering, hot-melt extrusion, spray drying, and supercritical fluid processing each offer their own trade-offs between dissolution advantage, physical stability, and manufacturability. A special issue devoted to these methods arrives at a moment when regulators and industry alike are demanding deeper mechanistic understanding of why a given particle design works and how it will behave over a product’s shelf life.

Equally significant is the issue’s emphasis on advanced formulation strategies across the full range of administration routes: oral, injectable, inhalable, transdermal, and beyond. Each route imposes its own physical constraints. Inhaled medicines, for example, require particles engineered to aerodynamic diameters typically between one and five micrometers so they can deposit in the deep lung rather than being exhaled or trapped in the throat. Injectable formulations must balance osmolality, pH, and sterility while increasingly incorporating complex biologics that denature under stress. Transdermal systems depend on drug properties and formulation design that allow molecules to traverse the stratum corneum, the skin’s formidable barrier layer. By soliciting contributions across all of these modalities, the editors are signaling that particle and formulation science is not a niche discipline but a unifying framework that governs drug delivery in every compartment of the body.

Solid-state characterization and control form a third pillar of the issue, and this is where modern analytical technology has transformed the field. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to determine not merely which polymorphic form of a drug is present, but how much of it, whether it is transforming over time, and how processing history shapes the final product. The importance of this work was underscored by historical cases in which a drug product on the market converted to a different, less soluble crystal form, with serious consequences for efficacy and for the companies involved. Regulatory frameworks now expect applicants to demonstrate thorough control of solid form throughout development, making solid-state science a gatekeeping discipline for the entire pharmaceutical pipeline.

Perhaps the most distinctive feature of the special issue is its explicit focus on translational formulation science and scale-up. The gap between an elegant formulation prepared in a laboratory beaker and a product manufactured in tons on a production line is one of the most persistent sources of failure in pharmaceutical development. A suspension that is stable at milliliter scale may aggregate or sediment unpredictably when produced at industrial volume. A spray-dried dispersion optimized on a bench-scale dryer may show different residual moisture, particle morphology, and flow behavior in a commercial unit. Scale-up forces formulators to confront mixing dynamics, heat transfer, drying kinetics, and equipment geometry that laboratory studies rarely capture. Contributions that document how a formulation survived this journey, or explain mechanistically why it did not, are among the most valuable papers the field can publish, and their scarcity in the literature has long been a source of frustration for industrial scientists.

Emerging manufacturing technologies constitute another headline theme. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than moving batch by batch between separate steps, has moved from concept to commercial reality in recent years, with regulatory approvals of continuously manufactured drug products in both the United States and Japan. Additive manufacturing, including three-dimensional printing of dosage forms, opens the possibility of products with complex internal geometries that control release kinetics in ways conventional compression cannot achieve. Meanwhile, advances in hot-melt extrusion, electrospinning, and microfluidic nanoparticle production are expanding the toolbox available to formulators. The special issue’s call for work on emerging technologies in dosage form design and commercial production invites authors to address not just what these methods can do in principle, but what evidence supports their reliability, control, and economic viability at scale.

Woven through all of these themes is the twin framework of Quality by Design and Process Analytical Technology, known throughout the industry as QbD and PAT. QbD inverts the traditional approach to pharmaceutical quality: instead of testing finished products to catch defects, developers design the manufacturing process around a thorough understanding of how raw material attributes and process parameters determine critical quality attributes, then build control strategies to keep those attributes within proven acceptable ranges. PAT supplies the sensory apparatus for this philosophy, using real-time tools such as near-infrared spectroscopy, Raman spectroscopy, and laser diffraction to monitor blend uniformity, granule size, and drug content as production proceeds. The combination allows manufacturers to detect and correct drift before it produces out-of-specification material, and regulators have increasingly encouraged its adoption. Papers that demonstrate QbD principles applied to particle engineering, for instance linking feedstock polymorph to final dissolution performance through a designed experiment, would sit squarely within the issue’s scope.

The timing of the issue is notable for reasons that extend beyond any single technology. The pharmaceutical industry is simultaneously absorbing the rise of biologics and RNA therapeutics, the growth of personalized and precision dosing, and mounting pressure to shorten development timelines and reduce manufacturing costs. Formulation science sits at the intersection of all of these pressures. A poorly soluble molecule discovered by artificial intelligence-guided screening still needs a particle engineer to make it absorbable. A breakthrough biologic still needs a stabilizing matrix to survive months in a vial. A printed personalized tablet still needs a validated, controlled process to be manufactured safely. By framing the special issue around translational advances, the editors are emphasizing that the value of formulation research is measured not in publications but in products, and that the path from particle to patient is where the discipline’s next chapter will be written.

For researchers considering submission before the June 30, 2026 deadline, the scope outlined by Hwang, Kim, and Park offers broad latitude: anything from fundamental studies of nucleation and crystal growth to applied demonstrations of continuous manufacturing lines and real-time process control falls within the issue’s remit. What unites the topics is a demand for rigor and relevance, for work that characterizes materials deeply, explains mechanisms clearly, and connects laboratory findings to the constraints of real production. If the field delivers on that promise, the January 2027 issue could stand as a useful snapshot of a discipline in ascent, one in which the physical form of a medicine is finally recognized as inseparable from its therapeutic power, and in which the scientists who shape crystals, powders, and particles are acknowledged as central actors in modern drug development.

Subject of Research: 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

DOI: Not provided

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