Particle Engineering and Formulation Science Drive Translational Drug Development Forward

Pharmaceutical formulation science is entering a period of unusual momentum, and one of the field’s leading journals has moved to capture that momentum in a dedicated collection of research. The Journal of Pharmaceutical Investigation has announced a special issue titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, scheduled for publication in January 2027. The issue is being assembled by a team of guest editors from South Korea’s academic research community: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. The deadline for manuscript submissions is June 30, 2026, giving researchers in industry and academia a defined window to contribute their latest findings.

The scope of the issue reflects where the intellectual center of gravity in formulation science currently sits. The editors are soliciting work across six thematic areas: particle engineering approaches for improving solubility, stability, and bioavailability; advanced formulation strategies for oral, injectable, inhalable, transdermal, and other dosage forms as well as advanced drug delivery systems; solid-state characterization and control in pharmaceutical development; translational formulation science and the scale-up of drug products; emerging manufacturing technologies in dosage form design and commercial production; and applications of Quality by Design and Process Analytical Technology in pharmaceutical formulation and manufacturing. Together, these themes trace the full arc of a medicine’s journey, from an engineered particle in a laboratory to a reproducible product manufactured at commercial scale.

The emphasis on particle engineering is particularly significant because it addresses one of the most persistent bottlenecks in modern drug development. An estimated large fraction of newly discovered drug candidates are poorly soluble in water, which limits their absorption in the gastrointestinal tract and can render promising molecules clinically useless. Particle engineering attacks this problem at its physical root. By reducing particle size to the micrometer or nanometer range, formulators dramatically increase the surface area available for dissolution, allowing the drug to enter solution more rapidly. Techniques such as wet milling, high-pressure homogenization, spray drying, and supercritical fluid processing all produce engineered particles whose size, shape, and surface properties can be tuned to maximize bioavailability.

Beyond simple size reduction, the field has developed sophisticated strategies that manipulate the solid state of the drug itself. Many poorly soluble compounds can be converted from a crystalline form, in which molecules are locked into a stable, low-energy lattice, to an amorphous form, in which they are disordered and far more soluble. The challenge is that amorphous materials tend to revert to crystals over time, undoing the solubility advantage. Stabilizing these materials requires careful control of molecular interactions between the drug and polymeric carriers, and this is where formulation science earns its keep. Solid dispersions, co-amorphous systems, and drug-polymer conjugates are among the approaches that researchers have refined to hold unstable solid states in suspension long enough for a product to reach patients with a reliable shelf life.

Polymorphism, the ability of a molecule to crystallize in multiple distinct forms, adds another layer of complexity. Different polymorphs of the same drug can differ in solubility, melting point, mechanical behavior, and chemical stability, which means that an unnoticed crystal form change during manufacturing or storage can alter a medicine’s performance. This is why solid-state characterization and control receives its own dedicated theme in the special issue. Techniques such as powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, and solid-state nuclear magnetic resonance spectroscopy allow scientists to fingerprint the solid form of a drug and detect even subtle transformations. Increasingly, these measurements are being embedded into routine manufacturing rather than reserved for the research laboratory.

The special issue’s attention to advanced drug delivery systems acknowledges that the drug and its delivery vehicle have become inseparable in modern therapeutics. Oral formulations still dominate the market, but inhalable powders for respiratory disease, long-acting injectable depots, transdermal patches that deliver drugs through the skin, and nanoparticle carriers that home in on diseased tissue all demand formulation science of a different character. An inhalable product, for example, must have particles sized within a narrow aerodynamic window, generally in the range of one to five micrometers, to reach the deep lung, and it must flow uniformly from a device under varying humidity. A transdermal patch must balance drug solubility in an adhesive matrix against the skin’s formidable barrier function. Each route of administration imposes its own physics, and the special issue invites contributions spanning all of them.

Perhaps the most distinctive theme of the collection is its emphasis on translational formulation science and scale-up. A formulation that performs beautifully in a beaker can fail when it meets a hundred-liter mixing vessel, a rotary tablet press running at industrial speed, or a spray dryer processing kilogram batches. Shear rates, drying temperatures, and residence times all change with scale, and a process that is robust at the bench may drift out of specification at production volume. Translational formulation science seeks to understand these dependencies mechanistically so that laboratory knowledge survives the journey to the factory floor. The COVID-19 pandemic made the stakes of this discipline vividly clear, as mRNA vaccine development exposed how sensitive advanced drug products can be to freezing, thawing, and handling, and how formulation choices can dictate the logistics of global distribution.

That connection between laboratory science and manufacturing reality explains the final two themes of the special issue: emerging manufacturing technologies and the applications of Quality by Design and Process Analytical Technology, known in the industry as QbD and PAT. QbD is a regulatory philosophy that replaces the older practice of testing finished products for quality with the practice of designing quality into the product from the start. Rather than fixing a recipe and hoping the output meets specifications, QbD developers identify the critical quality attributes of a product, map the process parameters and material properties that influence them, and build a design space within which the product is guaranteed to meet its targets. PAT complements this philosophy by providing the eyes inside the process. Inline and at-line sensors, including near-infrared spectroscopy and Raman spectroscopy, allow manufacturers to monitor powder blends, granulation end points, and drying processes in real time, closing the loop between measurement and control without halting production.

Emerging manufacturing technologies extend this vision further. Continuous manufacturing, in which raw materials flow through a connected train of unit operations to emerge as finished dosage forms, is steadily displacing the traditional batch model, offering shorter production times, smaller footprints, and tighter process control. Additive manufacturing, including 3D printing of tablets, makes it conceivable to adjust dose and release profile to individual patients. Hot-melt extrusion, electrospinning, and microfluidic crystallization each offer new routes to structures that conventional equipment cannot produce. When these technologies are paired with the analytical capability of PAT and the systematic rigor of QbD, the result is a manufacturing paradigm in which a product’s quality is understood, monitored, and controlled continuously rather than asserted after the fact.

The Journal of Pharmaceutical Investigation, published by Springer, has long served as a forum bridging pharmaceutical scientists in academia and industry, particularly across Asia, where much of the world’s formulation and manufacturing capacity is concentrated. By gathering work on particle engineering, solid-state control, advanced delivery, scale-up, and modern manufacturing under a single translational banner, the guest editors aim to present a coherent picture of how a molecule becomes a medicine. For researchers, the June 30, 2026 submission deadline marks the moment to distill their most rigorous findings into manuscripts that speak across disciplines. For the wider scientific community, the resulting issue, due in January 2027, promises a snapshot of a discipline that quietly determines whether the drugs of the future will ever survive the trip from discovery bench to pharmacy shelf.

Subject of Research: Translational advances in pharmaceutical dosage form development through 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: pharmaceutical formulation, particle engineering, drug delivery, solid-state characterization, bioavailability, scale-up, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solids, dosage forms, Journal of Pharmaceutical Investigation