A new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation, and its scope reveals just how much the field has changed. Titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, the issue will be published in January 2027, with a submission deadline of June 30, 2026. Guest editors Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University are soliciting research that spans the full journey of a medicine, from the behavior of a single crystal to the machinery that fills millions of tablets a day. The framing is deliberate: the emphasis on translational advances signals that laboratory elegance alone is no longer enough. What matters now is whether a clever particle design survives scale-up, regulatory scrutiny, and the harsh economics of commercial manufacturing.

The first pillar of the issue, particle engineering for solubility, stability, and bioavailability enhancement, addresses one of the most stubborn bottlenecks in the industry. An estimated large fraction of new drug candidates emerging from discovery pipelines are poorly water-soluble, meaning that even a pharmacologically brilliant molecule may never reach therapeutic concentrations in a patient’s bloodstream. Particle engineering attacks this problem at its physical root. By reducing particle size into the micron or nanometer range, formulators dramatically increase the surface area available for dissolution, since the rate at which a solid dissolves is proportional to its exposed surface. Nanocrystal suspensions, for example, can raise the apparent solubility of a drug simply by shrinking its particles, allowing oral doses to be absorbed more completely without chemically altering the molecule itself.

Beyond size reduction, the field manipulates the solid state of the drug. Many active pharmaceutical ingredients exist in multiple crystalline forms, or polymorphs, each with a distinct lattice arrangement and therefore distinct thermodynamic properties. A metastable polymorph or an amorphous solid dispersion can be far more soluble than the stable crystal form, but that advantage comes with a risk: the material may spontaneously revert to a less soluble, more stable state during storage, erasing the bioavailability benefit and potentially failing regulatory specifications. Hot-melt extrusion, spray drying, and cryogenic milling are among the techniques used to generate and stabilize these high-energy forms, often by dispersing the drug in a polymeric matrix that kinetically traps it in its amorphous state. The special issue’s call for work on solid-state characterization and control reflects how central this balancing act has become, since a formulation that cannot be proven stable over a two-year shelf life is a formulation that will never reach a pharmacy.

The second major topic, advanced formulation strategies across oral, injectable, inhalable, and transdermal routes, underscores that particle science is not confined to pills. Each route of administration imposes its own engineering constraints. Inhaled medicines, for instance, must deliver particles in a narrow aerodynamic size window, typically one to five micrometers, so that they deposit in the deep lung rather than being exhaled or trapped in the throat. That requirement has driven innovations in carrier surface engineering for dry powder inhalers and in the design of propellant-free suspensions for metered-dose devices. Injectable formulations face an entirely different set of demands, including sterility, isotonicity, and the need for some biologics to remain stable in suspension for months. Transdermal systems must push drugs through the stratum corneum, the skin’s formidable lipid barrier, using chemical enhancers, microneedle arrays, or drug-loaded adhesives. The special issue explicitly invites work on advanced drug delivery systems, a category that increasingly includes long-acting injectables and combination products where the device and the formulation must be co-optimized.

What distinguishes this collection from a purely academic exercise is its insistence on translational formulation science and scale-up. The gap between a successful bench experiment and a validated commercial process is notoriously wide. A spray-drying condition that produces beautiful amorphous particles on a laboratory scale may yield inconsistent material when the solvent feed rate, drying gas temperature, and atomization pressure are scaled to industrial throughput. Mixing, granulation, and compression behave differently in large equipment because heat transfer, residence time distribution, and mechanical stress do not scale linearly. Translational research in this context means building formulations with manufacturability in mind from the outset: choosing excipients that are available in pharmaceutical grade, designing processes that tolerate realistic input variability, and generating the stability and performance data that regulators require. The guest editors’ backgrounds in pharmaceutics and drug delivery suggest the issue will favor exactly this kind of end-to-end thinking.

Emerging manufacturing technologies form another pillar of the call for papers, and this is where the field is changing fastest. Continuous manufacturing, in which raw materials flow through connected unit operations without batch interruptions, is steadily displacing traditional batch processing for solid oral doses. Continuous blending, twin-screw hot-melt extrusion, and continuous tableting allow tighter process control and smaller facility footprints, and regulators have increasingly supported the approach because it reduces the risk of human error and enables real-time release testing. Additive manufacturing, better known as three-dimensional printing, has produced dosage forms with geometries impossible to achieve by compression, including printlets with tailored porosity and multi-drug polypills whose release profiles are encoded in their printed structure. These technologies are not laboratory curiosities; several printed and continuously manufactured products have already navigated regulatory pathways, and the special issue’s inclusion of commercial production in its scope signals that the editors want papers describing technologies that are ready, or nearly ready, for the factory floor.

Woven through every topic is the language of Quality by Design and Process Analytical Technology, two paradigms that have reshaped how pharmaceutical development is documented and controlled. Quality by Design, or QbD, inverts the traditional development logic. Instead of testing a finished batch and hoping it passes, developers first define the quality target product profile, identify the critical quality attributes that determine safety and efficacy, and then map how every material attribute and process parameter influences those attributes. The result is a design space, a multidimensional region of operating conditions within which quality is assured, and regulators can approve flexibility to operate anywhere inside it. Process Analytical Technology, or PAT, supplies the real-time eyes for this framework: near-infrared spectroscopy, Raman spectroscopy, and laser diffraction probes mounted directly on production equipment measure blend uniformity, drug concentration, and particle size distribution as the process runs, allowing operators to adjust parameters before a deviation becomes a rejected batch.

The convergence of QbD and PAT with particle engineering is producing a new generation of self-correcting manufacturing systems. In a continuous granulation line equipped with inline spectroscopy, a drift in raw material moisture can be detected within seconds and compensated by adjusting the liquid feed, keeping the granule size distribution inside its approved design space without stopping production. For amorphous solid dispersions, inline Raman monitoring can confirm that the drug remains molecularly dispersed in the polymer rather than recrystallizing during extrusion, a failure mode that is invisible to the naked eye until stability testing reveals it months later. Digital twins, mechanistic process models calibrated with PAT data, are extending this logic further, allowing manufacturers to simulate scale-up on a computer before committing to expensive production campaigns. Papers describing such integrated approaches are precisely what the special issue’s sixth topic is designed to attract.

The significance of this agenda extends beyond engineering efficiency. Formulation science increasingly determines which drugs are commercially viable at all. Biologics, antibody fragments, peptides, and mRNA therapeutics are often fragile molecules that demand sophisticated stabilization strategies, from lyophilization cycles optimized particle by particle to lipid nanoparticle platforms whose size and surface charge dictate cellular uptake. As patent cliffs push the industry toward differentiated generics and 505(b)(2)-style products, the ability to reformulate an existing molecule into a longer-acting, better-tolerated, or more convenient dosage form has become a primary engine of innovation. A drug that can be given once monthly by subcutaneous injection instead of daily by tablet, or inhaled instead of injected, can transform patient adherence and open new markets, and every one of those advances rests on the particle and formulation science this special issue celebrates.

For researchers hoping to contribute, the practical details are clear. Manuscripts are due by June 30, 2026, for publication in the January 2027 issue of the Journal of Pharmaceutical Investigation, and the guest editors welcome contributions across the six announced topics, from fundamental particle characterization to validated commercial manufacturing case studies. The collective message of the call is that the boundary between the pharmacy bench and the production plant has effectively dissolved. The most valuable work in dosage form development today is work that treats a crystal’s lattice energy, a polymer’s glass transition temperature, an extruder’s screw speed, and a regulator’s expectations as parts of a single design problem. The January 2027 issue aims to showcase research that solves that problem end to end, and in doing so, to chart where the next decade of drug delivery will go.

Subject of Research: Translational pharmaceutical dosage form development using 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, Quality by Design, Process Analytical Technology, continuous manufacturing, amorphous solid dispersions, scale-up, Journal of Pharmaceutical Investigation, pharmaceutical manufacturing