The premise behind the issue is deceptively simple. Discovering a potent molecule is only the first step in creating a therapy; if that molecule cannot be dissolved, absorbed, stabilized, and manufactured at scale, it will never help a single patient. Industry estimates have long suggested that a large fraction of newly discovered drug candidates, particularly the small molecules emerging from modern high-throughput screening, suffer from poor aqueous solubility. A compound that dissolves poorly in water dissolves poorly in the fluids of the gastrointestinal tract, and poor dissolution means poor and unpredictable absorption. Particle engineering, the deliberate manipulation of crystal form, particle size, shape, and surface properties, has become one of the most powerful toolkits for rescuing such molecules from development failure.

The special issue’s stated topics read like a map of the field’s current hot spots. Among them are particle engineering approaches for enhancing solubility, stability, and bioavailability; advanced formulation strategies spanning oral, injectable, inhalable, and transdermal dosage forms; solid-state characterization and control; translational formulation science and the scale-up of drug products; emerging manufacturing technologies; and the application of Quality by Design and Process Analytical Technology, known respectively as QbD and PAT, to pharmaceutical formulation and manufacturing. Together these themes trace the full arc of a drug product’s life, from the first micronized powder to the validated commercial production line.

Consider what particle engineering actually involves in practice. A drug molecule may crystallize in several different solid-state forms, called polymorphs, each with a distinct arrangement of molecules in the crystal lattice and, crucially, distinct solubility and stability profiles. Choosing the wrong polymorph can be catastrophic; the late-1990s withdrawal of a major HIV medication after a more stable, less soluble crystal form began appearing in commercial batches remains a defining cautionary tale for the industry. Formulation scientists therefore deploy an arsenal of characterization techniques, including X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption, and spectroscopic methods, to identify and monitor the exact solid state of a drug throughout development. The special issue’s emphasis on solid-state characterization and control reflects how central this vigilance has become to regulatory expectations worldwide.

When conventional crystallization cannot deliver the needed performance, more aggressive particle engineering strategies enter the picture. Milling and jet milling reduce particle size to increase surface area and accelerate dissolution. Nanocrystal technologies push particles into the submicron range, where dissolution pressure rises steeply and poorly soluble drugs can achieve clinically useful absorption. Amorphous solid dispersions take a different route, locking the drug in a disordered, high-energy glassy state stabilized within a polymer matrix, trading thermodynamic stability for dramatically improved apparent solubility. Each approach carries its own manufacturing and stability challenges, and each depends on precise control of process conditions, which is precisely why the field increasingly frames formulation development as an engineering discipline rather than an empirical art.

The special issue’s inclusion of advanced drug delivery systems across multiple routes of administration signals another important shift. Formulation science is no longer confined to the tablet press. Inhalable powders demand exquisite control of particle aerodynamic diameter so that drug particles reach the deep lung rather than lodging in the throat. Injectable formulations must balance solubility, osmolality, and sterility while increasingly incorporating biologics that are fragile and prone to aggregation. Transdermal systems rely on particle and matrix engineering to drive molecules across the skin’s formidable barrier. By inviting contributions across all of these routes, the editors are acknowledging that the same underlying principles of particle science and formulation design now govern an extraordinarily diverse range of therapeutic products.

Perhaps the most forward-looking themes in the call for papers concern manufacturing. Emerging technologies such as hot-melt extrusion, spray drying, and additive manufacturing, including the first 3D-printed tablet approved by regulators in recent years, are reshaping how dosage forms are designed and produced. Continuous manufacturing, which replaces the traditional batch-based model with an uninterrupted flow of material through integrated unit operations, promises shorter development timelines, smaller footprints, and more consistent product quality. These technologies dovetail naturally with Process Analytical Technology, in which real-time sensors embedded in the production line monitor critical quality attributes as they form, allowing operators to detect and correct deviations before they produce out-of-specification product.

Quality by Design provides the philosophical framework that ties these manufacturing advances together. Rather than testing finished products to catch defects, QbD asks developers to build quality into the product from the start: to identify the critical quality attributes that determine clinical performance, understand which process parameters and material properties control those attributes, and establish a design space within which the product is guaranteed to meet its specifications. Regulatory agencies in the United States, Europe, and elsewhere have championed this paradigm for nearly two decades, and its marriage with real-time PAT monitoring is widely seen as the foundation of the next generation of pharmaceutical manufacturing. The special issue’s explicit pairing of QbD and PAT among its topics underscores how thoroughly this thinking has permeated formulation science.

The word translational in the issue’s title deserves particular attention. Academic formulation research has sometimes been criticized for producing elegant laboratory results that falter when confronted with the realities of GMP manufacturing, regulatory scrutiny, and commercial economics. By foregrounding scale-up and commercial production, the guest editors are signaling that they want work which survives the journey from bench to plant floor. That journey is notoriously difficult: a nanocrystal suspension that performs beautifully at milliliter scale may aggregate, erode equipment, or behave unpredictably when produced in thousands of liters. Bridging that gap requires the kind of interdisciplinary collaboration between academic scientists, formulation engineers, and industry technologists that the special issue is explicitly designed to foster.

For researchers hoping to contribute, the timeline is clear. Manuscripts are due by June 30, 2026, with publication of the completed issue planned for January 2027 in the Journal of Pharmaceutical Investigation, a peer-reviewed journal published by Springer that focuses on pharmaceutical sciences and drug delivery research. As the pharmaceutical industry grapples with an ever-growing proportion of difficult-to-formulate molecules, including poorly soluble small molecules and complex biologics, the disciplines gathered under this special issue’s umbrella are moving from the periphery of drug development to its center. The medicines of the coming decade, from inhaled biologics to continuously manufactured personalized tablets, will be shaped as much by particle engineers and formulation scientists as by the chemists who first drew the molecules themselves. This special issue aims to document exactly how that transformation is unfolding.

Subject of Research: Particle engineering and formulation science for pharmaceutical dosage form development

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, solid-state characterization, Quality by Design, Process Analytical Technology, pharmaceutical manufacturing, bioavailability, dosage forms, scale-up, Journal of Pharmaceutical Investigation