Pharmaceutical Scientists Rally Around Particle Engineering to Fix Drug Delivery’s Toughest Problems

A major new special issue of the Journal of Pharmaceutical Investigation is set to gather the field’s leading minds around one of modern medicine’s most stubborn challenges: getting drugs into the body reliably, safely, and at scale. 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. It is being assembled by three guest editors from South Korea’s pharmaceutical research community: 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 lays out an ambitious agenda spanning solubility enhancement, advanced drug delivery systems, solid-state science, manufacturing scale-up, and the digital quality tools that increasingly govern how medicines are made.

The timing could hardly be better. An estimated large fraction of drug candidates emerging from discovery pipelines today are poorly soluble in water, a property that can doom a promising molecule before it ever reaches patients. When a compound dissolves too slowly or too incompletely in the gastrointestinal tract, the body absorbs too little of it, forcing higher doses, more frequent administration, or outright abandonment of the candidate. Particle engineering attacks this problem at its physical root. By reducing particle size into the micrometer and nanometer ranges, formulators dramatically increase the surface area available for dissolution, following the well-established Noyes-Whitney relationship that links dissolution rate to exposed surface area. Nanocrystal suspensions, produced by wet milling, high-pressure homogenization, or controlled precipitation, have already carried several blockbusters onto the market, and the techniques continue to evolve toward finer control of size distributions and surface properties.

But size is only one lever. The special issue’s first listed topic, particle engineering approaches for solubility, stability, and bioavailability enhancement, encompasses a family of strategies that manipulate the solid state of a drug itself. Many poorly soluble compounds exist in crystalline forms whose tightly packed lattices resist interaction with water. Converting a drug to an amorphous solid, in which molecules are arranged randomly as in a glass rather than in an ordered crystal, can raise apparent solubility by several-fold. The catch is stability: amorphous materials have a thermodynamic drive to recrystallize, which would erase the solubility advantage and potentially alter the product’s performance over its shelf life. Formulators fight back with glass solutions, in which the drug is molecularly dispersed in a polymer carrier and stabilized by intermolecular interactions, and with co-amorphous systems pairing the drug with a second small molecule. Hot-melt extrusion, spray drying, and more recently electrospinning and cryomilling are among the manufacturing routes used to generate these metastable phases reproducibly.

Polymorphism, the ability of a single molecule to crystallize in multiple distinct forms, adds another layer of complexity that the special issue explicitly targets through its topic on solid-state characterization and control. Different polymorphs can differ in melting point, dissolution rate, mechanical properties, and chemical stability, and regulatory agencies require manufacturers to identify and control the form used in a product. The most infamous cautionary tale remains ritonavir, an HIV drug whose second, more stable polymorph surfaced unexpectedly in the late 1990s and effectively halted production until the problem was solved. Modern analytical arsenic, so to speak, includes powder X-ray diffraction, differential scanning calorimetry, dynamic vapor sorption, solid-state nuclear magnetic resonance, and Raman spectroscopy, often deployed in combination to build a complete picture of a material’s solid-state landscape. Computational crystal structure prediction is increasingly used alongside these tools to assess whether undiscovered, potentially problematic forms might lurk beyond those found experimentally.

The second pillar of the call for papers, advanced formulation strategies for pharmaceutical dosage forms and drug delivery systems, stretches across every route of administration. Oral solid dosage forms remain the workhorse of the pharmaceutical industry, prized for patient convenience and manufacturing economy, and innovation there includes modified-release architectures that choreograph drug release over hours, gastroretentive systems that extend residence time in the stomach, and fixed-dose combinations that pack multiple actives into a single tablet. Injectable formulations demand entirely different constraints: sterility, isotonicity, acceptable viscosity for syringeability, and control of protein aggregation for the growing class of biologic drugs. Inhalable products must balance aerodynamic particle size, typically targeting the one-to-five-micrometer range for deep lung deposition, with the device engineering needed to disperse powder consistently with each breath. Transdermal systems, from matrix patches to microneedle arrays that painlessly breach the stratum corneum, promise needle-free delivery of molecules that would otherwise be destroyed by first-pass metabolism in the liver.

What unites these diverse routes is the translational question that gives the special issue its name: how do laboratory-scale innovations become robust commercial products? A formulation that performs beautifully in a beaker can fail spectacularly when scaled to hundreds of kilograms. Mixing times, heat transfer, drying kinetics, and compaction behavior all change with scale, and subtle shifts in process conditions can convert a desired polymorph into an unwanted one or push an amorphous system past its crystallization threshold. The special issue’s topic on translational formulation science and scale-up of drug products invites contributions that document these journeys, including the analytical bridging studies that demonstrate a scaled process delivers the same product as the original. Case studies of technology transfer, particularly for enabling technologies like nanocrystals and amorphous solid dispersions, are exactly the kind of practical knowledge the field’s literature has historically under-supplied.

Emerging manufacturing technologies form another headline topic. Continuous manufacturing, in which raw materials flow through an integrated train of unit operations rather than sitting in batch vessels, is reshaping how small-molecule drugs are produced. Hot-melt extrusion is inherently continuous, and continuous blending, granulation, and tableting lines now operate under regulatory approvals in several markets. The appeal is twofold: smaller footprints and inventories, and tighter, real-time control of product attributes. Additive manufacturing has entered the conversation as well, with printing technologies capable of producing tablets with complex internal geometries and personalized doses, an approach validated by the first regulatory approval of a printed medicine. For biologics, advances in aseptic processing, including closed-system filling and isolator technology, are reducing contamination risk while enabling the high-concentration formulations that patients increasingly prefer in lower-volume injections.

Woven through all of these topics is the quality framework that regulators and industry have converged on over the past two decades: Quality by Design, or QbD, and its operational partner, Process Analytical Technology, or PAT. QbD inverts the traditional approach to pharmaceutical quality. Rather than testing finished products and rejecting failures, manufacturers first define the quality target product profile, identify the critical quality attributes that determine safety and efficacy, and map the critical material attributes and process parameters that control them. The result is a design space, a multidimensional region of operating conditions within which quality is assured by design, giving manufacturers regulatory flexibility to adjust processes without prior approval. PAT supplies the sensory apparatus: near-infrared and Raman spectroscopy probes embedded in process streams, inline particle size analyzers, and mass spectrometry interfaces that feed continuous data into control systems. Together they enable real-time release testing, in which product quality is confirmed during manufacture rather than days later in a quality-control laboratory.

The guest editors’ institutional affiliations reflect the strength of Korean pharmaceutical formulation science on the global stage. Sung-Joo Hwang at Yonsei University has a long record in drug delivery and formulation development, Min-Soo Kim at Pusan National University works extensively on particle engineering and solubility enhancement, and Heejun Park at Duksung Women’s University contributes expertise in pharmaceutical formulation and physical pharmacy. Their stewardship signals that the issue will emphasize both fundamental rigor and industrial relevance, a combination the Journal of Pharmaceutical Investigation has cultivated as a bridge between academic discovery and commercial practice in Asia and beyond.

For researchers, the June 30, 2026 deadline leaves roughly a year and a half to prepare contributions, and the scope is broad enough to welcome work ranging from molecular-level solid-state studies to full-scale manufacturing case reports. For the industry and the patients it serves, the stakes are concrete. Every improvement in solubility enhancement can rescue a drug candidate that would otherwise be shelved; every advance in continuous manufacturing and PAT can shorten the path from plant to pharmacy and reduce the risk of recalls rooted in solid-state surprises; and every refinement in delivery technology can make medicines easier to take, more comfortable to receive, and more effective once inside the body. The special issue arrives at a moment when the pharmaceutical sciences are increasingly recognized not as a downstream service to drug discovery but as a decisive discipline in its own right, one that determines whether the molecules of tomorrow ever become the medicines of today. Submissions and editorial correspondence are directed to the three guest editors through the journal, and the published collection is expected in January 2027.

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

DOI: Not provided

Keywords: particle engineering, formulation science, drug delivery, solubility enhancement, bioavailability, solid-state characterization, polymorphism, amorphous solid dispersions, Quality by Design, Process Analytical Technology, continuous manufacturing, Journal of Pharmaceutical Investigation