Pharmaceutical Scientists Unite to Turn Lab Formulations into Real Medicines

A major new special issue of the Journal of Pharmaceutical Investigation is set to gather some of the most consequential work in modern drug formulation science, with a March toward the pharmacy shelf as its unifying theme. Titled Translational Advances in Pharmaceutical Dosage Form Development Based on Particle Engineering and Formulation Science, the collection will be published in January 2027, and researchers have until June 30, 2026 to submit their work. The issue is being steered by three guest editors from South Korean institutions: Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University. Their call for papers describes an ambition that goes well beyond academic curiosity, focusing instead on the notoriously difficult journey from a promising molecule to a stable, manufacturable, patient-ready dosage form.

The challenge these editors are targeting is one of the quiet crises of modern pharmacology. An estimated large fraction of new drug candidates emerging from discovery pipelines are poorly soluble in water, which severely limits how much of the compound the human body can actually absorb. A molecule may bind its biological target with exquisite precision in a test tube, yet fail utterly in a patient because it never dissolves in the gastrointestinal tract. Particle engineering exists precisely to close that gap. By manipulating crystals, particles, and powders at scales from nanometers to micrometers, formulation scientists can change dissolution rate, physical stability, flow behavior, and ultimately bioavailability without altering the drug molecule itself. It is a discipline where physics, chemistry, and chemical engineering converge on a deceptively simple question: how do you make a medicine that works in the real world?

The special issue’s scope makes this translational emphasis explicit. Among the core topics are particle engineering approaches for solubility, stability, and bioavailability enhancement, advanced formulation strategies for oral, injectable, inhalable, and transdermal dosage forms, solid-state characterization and control, translational formulation science and scale-up of drug products, emerging manufacturing technologies, and the application of Quality by Design and Process Analytical Technology in formulation and manufacturing. Taken together, these themes trace the full arc of drug product development, from the first manipulation of a crystalline powder to the validated, regulated process that stamps out millions of identical tablets or fills vials of biologic injectables.

Solid-state science deserves particular attention, because the physical form of a drug can be as consequential as its chemical structure. The same molecule may exist as multiple crystalline polymorphs, each with a different packing arrangement and therefore different solubility, melting point, and stability profile. The most famous cautionary tale is ritonavir, an HIV drug that spontaneously converted to a more stable, far less soluble crystal form in the late 1990s, forcing a market withdrawal and a costly reformulation. Amorphous solid dispersions, in which a drug is trapped in a glassy polymer matrix, sidestep crystallinity entirely to achieve dramatic solubility gains, but they carry their own risk: the amorphous material may slowly crystallize on the shelf, eroding the very benefit it was designed to deliver. Robust solid-state characterization, using techniques such as powder X-ray diffraction, differential scanning calorimetry, and dynamic vapor sorption, is what allows formulators to predict and prevent such failures before patients ever see them.

Particle size itself is a powerful lever. Reducing particles to the nanoscale multiplies their surface area per unit mass, accelerating dissolution in accordance with the Noyes-Whitney relationship and improving oral absorption for poorly soluble drugs. Nanocrystal formulations have already reached the market for several drugs. For inhalable medicines, the physics shifts: particles must land in the deep lung rather than dissolve in gut fluid, which demands a narrow aerodynamic diameter typically in the range of one to five micrometers, careful control of powder cohesion, and device engineering that turns a dry powder or a propellant-driven spray into a precisely deposited dose. For injectables, particle engineering governs everything from the stability of lipid nanoparticles carrying mRNA vaccines to the dissolution behavior of long-acting depot suspensions designed to release drug over weeks or months from a single injection.

The issue’s inclusion of scale-up as a distinct theme acknowledges a hard truth of pharmaceutical manufacturing: a formulation that performs beautifully with a few grams of material in a laboratory beaker can fail spectacularly when produced in ton quantities. Mixing efficiency, drying kinetics, granule growth, and electrostatic charging all change with scale. Wet granulation, hot-melt extrusion, spray drying, and supercritical fluid technologies each present their own transfer challenges when a process moves from bench to pilot plant to commercial line. Translational formulation science is, at its core, the discipline of anticipating those changes, building predictive models of how unit operations will behave at production scale, and designing processes that remain within tight quality limits regardless of batch size.

This is where the framework of Quality by Design, or QbD, enters the picture. Rather than testing finished products and hoping defects are caught, QbD asks manufacturers to first define the quality attributes that matter clinically, then identify the process parameters and material properties that control those attributes, and finally build a design space within which the product is guaranteed to meet specifications. Process Analytical Technology, or PAT, supplies the real-time instrumentation that makes this practical: near-infrared spectroscopy probes monitoring blend uniformity inside mixers, Raman sensors tracking polymorphic form during drying, and laser diffraction measuring particle size distributions continuously during milling. The regulatory environment, particularly guidance from the United States Food and Drug Administration and the International Council for Harmonisation, has increasingly encouraged these approaches, rewarding manufacturers who demonstrate deep process understanding with greater operational flexibility.

Emerging manufacturing technologies add a further layer of transformation. Continuous manufacturing, which replaces the traditional batch model with an unbroken production line from powder feed to finished tablet, is gaining ground because it offers tighter control, smaller footprints, and faster response to demand. Additive manufacturing, including 3D printing of oral dosage forms, opens the possibility of medicines tailored to individual patients, printing doses and release profiles customized to a child’s weight or an adult’s metabolic profile. Advanced delivery systems, from long-acting injectables to transdermal patches and microneedle arrays, blur the line between formulation science and medical device engineering, and each depends on the same underlying particle and materials expertise that the special issue seeks to showcase.

For the guest editors, the unifying thread across all these technologies is translation: the demonstration that a formulation concept not only works in a laboratory but survives the journey through scale-up, regulatory scrutiny, and commercial production to reach patients. That journey is where a large share of development time and cost accumulates, and it is where scientific innovation has historically been hardest to document, because translational work requires industrial data, validated processes, and often proprietary manufacturing know-how. By devoting an entire issue to this stage of pharmaceutical science, the Journal of Pharmaceutical Investigation is signaling that the bridge between discovery and delivery is itself a frontier worthy of rigorous, high-quality publication.

Researchers working in any corner of this field, from crystallographers designing new solid forms to engineers building continuous manufacturing lines, now have a defined venue and a deadline of June 30, 2026 for their submissions, with the finished issue slated for January 2027. The topics laid out by Hwang, Kim, and Park read less like a conventional call for papers and more like a map of how modern medicines are actually made: molecules engineered at the particle level, formulations validated through deep solid-state understanding, processes designed by quality-first principles, and manufacturing technologies that keep pace with increasingly sophisticated therapeutic payloads. For patients, the outcome of this kind of science is invisible but decisive: it is the difference between a drug that works and one that merely exists on paper, between a medicine that dissolves and reaches its target and one that passes uselessly through the body. The special issue aims to accelerate exactly that kind of difference.

Subject of Research: Translational 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

Image Credits: AI Generated

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Keywords: pharmaceutical formulation, particle engineering, drug solubility, bioavailability, solid-state characterization, Quality by Design, Process Analytical Technology, drug delivery systems, scale-up manufacturing, continuous manufacturing, nanocrystals, Journal of Pharmaceutical Investigation