The central premise of the special issue is that the physical form of a drug particle is not a trivial detail but a decisive factor in whether a medicine works. Many of the most promising drug molecules discovered in recent decades are poorly soluble in water, which means they can pass through the digestive tract without being adequately absorbed. Particle engineering addresses this problem by manipulating properties such as crystal form, particle size, surface characteristics, and morphology to improve how a drug dissolves, remains stable on the shelf, and ultimately reaches the bloodstream. The special issue explicitly invites work on particle engineering approaches aimed at enhancing solubility, stability, and bioavailability, three pillars that determine whether a formulation succeeds in the clinic.

One of the most active areas in this field involves reducing particle size to the micrometer and nanometer scales. As particles become smaller, their surface area to volume ratio increases dramatically, accelerating dissolution rates according to well-established physical principles. Techniques such as wet milling, high-pressure homogenization, spray drying, and supercritical fluid processing allow scientists to generate drug particles with precisely controlled dimensions. At the nanoscale, additional phenomena come into play, including increased saturation solubility and altered particle interactions, which can be harnessed to boost the absorption of otherwise stubborn molecules. Yet smaller particles also bring challenges, such as aggregation tendencies and physical instability, which is why the interplay between engineering and formulation strategy is so critical.

Closely related is the science of solid-state control. A single drug molecule can exist in multiple crystalline forms, known as polymorphs, as well as in amorphous states that lack long-range molecular order. Each form can exhibit different solubility, dissolution behavior, mechanical properties, and stability. Selecting the right solid form is therefore one of the most consequential decisions in drug development, and the special issue places solid-state characterization and control among its core topics. Modern analytical tools, including powder X-ray diffraction, differential scanning calorimetry, solid-state nuclear magnetic resonance, and vibrational spectroscopy, allow researchers to identify and monitor these forms with remarkable precision. The challenge lies in ensuring that the chosen form remains unchanged through manufacturing, storage, and administration, since an unintended transformation can compromise product performance.

Amorphous solid dispersions represent a particularly influential strategy in this domain. By dispersing a drug in a polymeric carrier in a non-crystalline state, formulators can achieve apparent solubility levels far above those of the crystalline compound. However, amorphous materials have a thermodynamic drive to recrystallize, and preventing that return to a less soluble state requires careful selection of polymers, processing conditions, and packaging environments. Hot-melt extrusion and spray drying are the dominant manufacturing routes for these systems, and both demand deep understanding of how heat, moisture, and mechanical stress affect the final product. Research submitted to the special issue on such advanced formulation strategies is expected to reflect this translational mindset, bridging laboratory innovation and real-world manufacturability.

The scope of the issue extends well beyond oral tablets and capsules. The call for papers explicitly covers advanced formulation strategies for injectable, inhalable, and transdermal dosage forms, among others, as well as advanced drug delivery systems. Each route of administration imposes its own particle and formulation requirements. Inhaled medicines, for example, depend on aerodynamic particle diameters in a narrow range, typically a few micrometers, to deposit in the lungs rather than the throat or mouth. Injectable formulations must balance sterility, isotonicity, and the risk of particles too large for safe intravenous administration. Transdermal systems must coax molecules through the skin’s formidable barrier, often relying on formulation design to control release rates over hours or days. Particle engineering thus serves as a unifying discipline across these diverse delivery challenges.

Translational formulation science and scale-up form another pillar of the issue. Moving a formulation from a laboratory bench to industrial production is notoriously difficult, because processes that work at gram scale can behave very differently at kilogram or ton scale. Mixing efficiency, drying kinetics, and heat transfer all shift with scale, and subtle changes can alter particle size distributions, blend uniformity, and solid form. The special issue’s emphasis on scale-up signals a desire for research that anticipates these hurdles, ensuring that discoveries in particle engineering survive the journey to commercial drug product. This translational focus aligns with the journal’s mission of connecting pharmaceutical science with practical therapeutic outcomes.

Emerging manufacturing technologies also feature prominently in the call for contributions. Continuous manufacturing, in which raw materials flow through connected processing units without batch interruptions, is reshaping pharmaceutical production by improving consistency and reducing cycle times. Additive manufacturing, including various three-dimensional printing approaches, enables dosage forms with complex internal architectures and personalized doses that conventional tableting cannot achieve. These technologies depend heavily on precise control of powders and particulate feedstocks, making particle engineering their indispensable foundation. Contributions on such emerging methods in dosage form design and commercial production are explicitly welcomed by the editors.

Quality by Design, commonly abbreviated as QbD, and Process Analytical Technology, known as PAT, round out the thematic scope. QbD is a regulatory and scientific philosophy that builds quality into a product from the outset, rather than testing it in afterward. It requires developers to understand which material attributes and process parameters critically affect product performance and to control them within proven design spaces. PAT complements this by embedding real-time sensors and analytics into manufacturing lines, allowing continuous monitoring of attributes such as particle size, moisture content, and blend homogeneity during production. Together, these frameworks turn formulation development from an empirical craft into a data-driven engineering discipline, and the special issue invites applications of both to pharmaceutical formulation and manufacturing.

For researchers working at the intersection of materials science, pharmaceutical technology, and regulatory science, the special issue represents a timely opportunity to consolidate the field’s translational momentum. With submissions due by June 30, 2026 and publication planned for January 2027, the timeline is designed to capture current advances at a moment when poorly soluble drugs, biologics, and personalized therapies are all straining the limits of conventional formulation approaches. Under the stewardship of editors Hwang, Kim, and Park, the issue aims to demonstrate that the path from molecule to medicine runs directly through the particle, and that mastering particle engineering and formulation science is essential for the next generation of drug products to reach patients safely and effectively.

Subject of Research: Particle engineering and formulation science in pharmaceutical dosage form development

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