The premise behind the special issue reflects a hard truth of pharmaceutical development. Discovering a molecule with therapeutic potential is only the beginning of a long and technically demanding journey. Many promising drug candidates, particularly the poorly water-soluble compounds that dominate modern discovery pipelines, fail not because they lack pharmacological activity but because they cannot be formulated into a dosage form that delivers them reliably to the right place in the body at the right concentration. Particle engineering and formulation science exist to solve precisely this problem, and the guest editors have framed the call for papers around the translational dimension of that challenge: how do advances made at the bench survive the journey through scale-up, regulatory scrutiny, and commercial manufacturing?

The topical scope of the issue is broad but coherent. The editors list six thematic areas, beginning with particle engineering approaches for enhancing solubility, stability, and bioavailability. This is the domain in which scientists manipulate the physical characteristics of drug particles, including their size, shape, crystal form, and surface properties, to overcome the limitations imposed by a molecule’s inherent chemistry. A drug that dissolves too slowly or too incompletely in the gastrointestinal tract may never achieve therapeutic blood levels, no matter how potent it is in a cell culture dish. By reducing particle size to the micrometer or even nanometer scale, converting a drug to a more soluble amorphous form, or engineering crystals with tailored habits, formulators can dramatically change how much of a dose actually gets absorbed.

The second thematic area covers advanced formulation strategies for pharmaceutical dosage forms and drug delivery systems, spanning oral, injectable, inhalable, and transdermal routes among others. Each route imposes its own set of constraints. Oral tablets must survive the acidic environment of the stomach and release their payload at the appropriate point in the intestine. Injectable formulations must be sterile, isotonic, and stable in solution or suspension for their entire shelf life. Inhaled products depend on exquisitely controlled particle aerodynamics so that the drug deposits in the deep lung rather than in the mouth and throat. Transdermal systems must push molecules through the skin’s formidable barrier layer without causing irritation. The special issue explicitly welcomes work across this entire spectrum, recognizing that formulation science is not a single discipline but a family of route-specific technologies united by common physical principles.

Solid-state characterization and control form the third pillar of the call. The solid form of a drug, whether crystalline, amorphous, or a salt or co-crystal, is not a fixed property but a choice, and that choice has profound consequences. Different polymorphs of the same molecule can differ in solubility, dissolution rate, physical stability, and even mechanical behavior during tableting. A formulation that works beautifully on day one can fail catastrophically if its amorphous component recrystallizes during storage, changing the drug’s performance in unpredictable ways. Techniques such as X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance allow scientists to identify exactly which form they have made and to monitor whether it remains that form over time. The translational question the editors are highlighting is how such characterization can be embedded into development workflows so that solid-state risks are identified and controlled early rather than discovered late.

Translational formulation science and the scale-up of drug products constitute the fourth theme, and arguably the one that gives the special issue its distinctive identity. Moving a formulation from a laboratory mixer holding a few grams to a production line processing hundreds of kilograms is never a simple matter of multiplication. Powder blending, granulation, drying, and compression all behave differently at scale, and subtle changes in equipment geometry, residence time, and heat transfer can alter the final product in ways that are difficult to predict. Many formulation failures in the pharmaceutical industry occur not at the discovery stage but during technology transfer, when a process validated in one facility must be reproduced in another. Research that quantifies these scale effects, develops predictive models, or demonstrates robust processes that tolerate manufacturing variability addresses one of the most expensive bottlenecks in bringing new medicines to market.

The fifth thematic area focuses on emerging manufacturing technologies in dosage form design and commercial production. This is where the field is changing most rapidly. Additive manufacturing, commonly known as three-dimensional printing, has opened the possibility of producing tablets with complex internal geometries and, in principle, doses personalized to individual patients. Continuous manufacturing, which replaces the traditional batch-based approach with an uninterrupted flow of material through integrated unit operations, promises shorter production times, smaller facility footprints, and more consistent product quality. Hot-melt extrusion, supercritical fluid technologies, electrospraying, and advanced spray-drying configurations are among the techniques being deployed to create amorphous solid dispersions and engineered particles that would have been impractical to manufacture a generation ago. The special issue invites contributions that move these technologies from proof-of-concept demonstrations toward validated, commercially viable processes.

The sixth theme, applications of Quality by Design and Process Analytical Technology, connects the scientific content of the issue to its regulatory context. Quality by Design, often abbreviated as QbD, is a paradigm in which product and process development begins with predefined quality objectives and proceeds through systematic experimentation to identify which formulation variables and process parameters critically affect the final product. Rather than testing quality into a finished product, manufacturers build it in from the start and define a design space within which the process can operate flexibly without regulatory filing changes. Process Analytical Technology, or PAT, supplies the real-time measurement tools that make this vision practical: near-infrared spectroscopy, Raman spectroscopy, and other inline sensors that monitor blend uniformity, granule moisture, or tablet hardness as the process runs, allowing immediate feedback and control rather than retrospective testing of samples.

What makes this special issue noteworthy for observers of pharmaceutical science is its explicit translational framing. Journals in this field routinely publish elegant studies of novel particles or clever formulations that never progress beyond the laboratory bench. By centering the issue on scale-up, manufacturing technologies, and QbD and PAT applications, the guest editors are signaling that the most valuable contributions are those that confront the realities of industrial production and regulatory expectations. The Journal of Pharmaceutical Investigation, published by Springer, has a long-standing focus on pharmaceutical formulation and drug delivery, and the January 2027 issue is positioned to serve as a snapshot of where the discipline stands as it absorbs the pressures of increasingly complex drug modalities, from poorly soluble small molecules to biologics that demand entirely new delivery vehicles.

For researchers considering submission, the practical parameters are clear. Manuscripts are due by June 30, 2026, with publication of the completed issue scheduled for January 2027. The scope spans the full lifecycle of dosage form development, from particle-level design and solid-state control through formulation strategy, manufacturing innovation, and quality systems. In an era when the pharmaceutical industry faces simultaneous pressure to develop more difficult molecules, to manufacture more sustainably and flexibly, and to deliver medicines with ever-greater precision, the questions this special issue addresses are not academic curiosities. They are the questions that determine whether a therapeutic breakthrough discovered in a laboratory ever becomes a medicine that a patient can swallow, inhale, inject, or wear. The editors’ call is, at its core, an invitation to close that gap, one engineered particle and one well-designed formulation at a time.

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, scale-up, continuous manufacturing, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, dosage forms, Journal of Pharmaceutical Investigation