Particle Engineering and Formulation Science Drive Next Wave of Drug Delivery Advances

Pharmaceutical formulation science is preparing for a major collective stocktaking. The Journal of Pharmaceutical Investigation has announced a special issue, scheduled for publication in January 2027, devoted to translational advances in pharmaceutical dosage form development based on particle engineering and formulation science. The issue will be guest edited by Sung-Joo Hwang of Yonsei University, Min-Soo Kim of Pusan National University, and Heejun Park of Duksung Women’s University, three South Korean researchers whose institutions sit at the center of a rapidly expanding Asian pharmaceutical development ecosystem. Researchers have until June 30, 2026 to submit their work, and the scope of the call reads like a map of the field’s most consequential technical frontiers.

At first glance, a journal special issue announcement might seem like an administrative event, of interest mainly to the authors who will submit papers. In reality, the topics listed in the call for papers describe the machinery by which molecules discovered in the laboratory become medicines that patients can actually swallow, inhale, inject, or wear on their skin. The gap between a promising compound and an approved drug product is frequently a formulation problem, and the disciplines named in this issue, particle engineering and formulation science, are the disciplines that close that gap. How a drug crystallizes, how large its particles are, how those particles disperse in the gastrointestinal tract or in the deep lung, and how the final dosage form survives months of storage all determine whether a molecule ever reaches its intended target at a therapeutic concentration.

The first topic flagged in the call, particle engineering approaches for solubility, stability, and bioavailability enhancement, addresses what is arguably the single most persistent bottleneck in modern drug development. Estimates across the industry consistently suggest that a large fraction of new chemical entities emerging from discovery pipelines are poorly soluble in water, a property that severely limits their oral absorption. Particle engineering attacks this problem by manipulating matter at scales from nanometers to hundreds of micrometers. Techniques such as wet milling, high-pressure homogenization, spray drying, and supercritical fluid processing can reduce drug particles to the nanoscale, where the dramatically increased surface area accelerates dissolution. Other strategies push further, converting crystalline drug into amorphous solid dispersions in which the molecules are locked in a disordered, higher-energy state that dissolves far more readily than the thermodynamically stable crystal. The catch is that this energetic advantage is inherently unstable, which is why the second pillar of the special issue, solid-state characterization and control, matters so much.

Solid-state science is the quiet detective work of pharmaceutics. A single drug molecule can exist in multiple crystalline forms, known as polymorphs, each with a distinct arrangement of molecules in the crystal lattice and therefore distinct solubility, melting behavior, mechanical properties, and stability. The consequences of ignoring this complexity are not hypothetical; the pharmaceutical industry’s history includes high-profile cases in which a marketed product converted to a different, less soluble polymorph after launch, forcing reformulation or withdrawal. Modern characterization relies on a battery of techniques including powder X-ray diffraction to identify crystal structure, differential scanning calorimetry to map thermal transitions, dynamic vapor sorption to probe hygroscopicity, and spectroscopic methods such as Raman and solid-state nuclear magnetic resonance to detect subtle molecular-level changes. The special issue’s emphasis on characterization and control signals that regulatory expectations continue to rise: developers are increasingly required not merely to identify the solid form they are manufacturing but to understand and justify why that form will remain unchanged through the product’s shelf life.

The second major theme, advanced formulation strategies across oral, injectable, inhalable, transdermal, and other routes, reflects the diversification of modern drug delivery. Each route imposes its own engineering constraints. Oral solid dosage forms, still the dominant product category worldwide, must survive the acidic environment of the stomach, release their payload at the right location in the intestine, and be manufacturable at rates of hundreds of thousands of tablets per hour. Injectable formulations face the opposite constraint of being introduced directly into tissue or bloodstream, which demands extreme purity, controlled osmolarity, and often the stabilization of delicate biologics such as monoclonal antibodies that would be destroyed by digestion. Inhaled medicines must generate aerosol droplets or dry powder particles in a narrow aerodynamic size range, typically one to five micrometers, so that they deposit in the lung rather than being exhaled or trapped in the throat. Transdermal systems must push molecules through the skin’s outermost barrier, the stratum corneum, using chemical penetration enhancers, adhesive matrix design, or in some cases physical technologies such as microneedles. A formulation scientist working across these routes is effectively a materials engineer, a physical chemist, and a process engineer at once.

Perhaps the most distinctive word in the special issue’s title is translational, and its companion topic, translational formulation science and scale-up of drug products, points to a challenge that has grown sharper as drug development has become more global and more compressed. A formulation that performs beautifully in a laboratory beaker is not necessarily one that can be produced reliably at industrial scale. Mixing, granulation, drying, compression, and coating processes all behave differently when scaled from kilograms to tonnes, and subtle changes in equipment geometry, temperature profiles, or residence times can alter the microstructure of the final product. Translational formulation science seeks to anticipate these shifts by building predictive understanding: relating measurable material properties of the drug and excipients to process behavior, and using that relationship to design manufacturing processes that are robust rather than fragile. The guest editors’ framing suggests they want contributions that demonstrate this bridge from bench to commercial reality, not merely elegant laboratory phenomena.

Emerging manufacturing technologies form another pillar of the call, and this is where the field’s recent transformation is most visible. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than sitting in batches between discrete steps, has moved from concept to commercial implementation in several approved products, offering tighter control and faster response to demand. Additive manufacturing, familiar from the broader 3D printing revolution, has produced orally disintegrating tablets with complex internal geometries that conventional compression cannot achieve. Hot-melt extrusion, electrospinning, and microfluidic nanoparticle production each offer routes to drug delivery architectures that were impractical a generation ago. These technologies are particularly significant for personalized and precision medicine, since flexible digital production could in principle adjust dose strengths for individual patients rather than forcing patients to fit fixed commercial strengths.

Woven through the entire call is the language of Quality by Design and Process Analytical Technology, two regulatory philosophies that have reshaped how pharmaceutical quality is conceived. Quality by Design, or QbD, inverts the traditional approach to manufacturing. Instead of testing finished products and rejecting failures, developers systematically identify the critical material attributes and critical process parameters that determine product quality, build a design space within which those variables can vary without compromising the product, and control the process within that space. Process Analytical Technology, or PAT, supplies the sensory apparatus for this approach: inline and at-line instruments such as near-infrared spectroscopy, Raman probes, and laser diffraction particle sizers that measure critical attributes in real time during production. Together, QbD and PAT turn manufacturing from an art of inspection into a science of control, and regulators in the United States, Europe, and Asia have progressively embedded these frameworks into their guidance documents.

The timing and composition of this special issue also say something about where pharmaceutical science is geographically heading. The Journal of Pharmaceutical Investigation, long a fixture of the Korean and broader Asian pharmaceutical research community, has increasingly positioned itself as a global venue, and the guest editorial team spans three Korean universities with strong drug delivery programs. Asia now hosts a substantial share of the world’s contract development and manufacturing capacity, and formulation science is one of the disciplines in which that capacity translates into original research rather than purely service work. A special issue that gathers contributions on nanosuspensions, amorphous dispersions, continuous processing, and inhaled delivery under one translational umbrella functions as both a snapshot and a signal: it tells young scientists which problems the field considers worth their careers.

For the broader readership, the significance of this announcement lies in what it reveals about the hidden engineering layer of modern medicine. Drug discovery captures headlines, but a molecule that cannot be formulated into a stable, manufacturable, patient-acceptable dosage form is a molecule that will never help anyone. The disciplines gathered in this special issue, particle engineering, solid-state control, advanced delivery, scale-up science, emerging manufacturing, and quality by design, are the disciplines that perform that conversion every day. With submissions open until June 30, 2026 and publication planned for January 2027, the issue promises to document how the pharmaceutical industry is learning to engineer not just molecules, but the medicines those molecules must become.

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

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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 dosage forms, special issue, Journal of Pharmaceutical Investigation