Editorial Pharmaceutical Industry Review, October No 2 (105) 2025


manufactures about five. Nevertheless, continuous technological stages such as roller compaction and material processing with extruders (including various types of granulations and hot-melt extrusion) have already become highly popular even among generic companies, whereas continuous film coating and fluid-bed processing (drying, granulation, coating) are applied less frequently. These stages may potentially be integrated into continuous manufacturing later, but this requires investment in PAT, adherence to higher technological discipline, and specialized personnel training. Among process analytical technologies that accompany continuous stages and provide real-time information, spectroscopic methods (e.g., Raman spectroscopy and near-infrared spectroscopy) prevail today. 3D printing of medicinal


products (not only oral forms) has already moved beyond being a university experiment and, in some European countries, is gradually replacing extemporaneous drug preparation. This is facilitated by the emergence of pharmaceutical 3D printers/printing methods and the introduction of new regulatory conditions. Nevertheless, tablets and capsules remain, and for a long time will remain, the predominant dosage forms for the mass market, due to industry readiness (equipment, methods, personnel), high production speed, and relatively low manufacturing cost. Although the process of


tableting has been widely applied for more than a century, and many high-quality fundamental textbooks on tableting were published at the end of the last century, in recent years, understanding of this process has reached a new level.


8 ПОВЕРНУТИСЯ ДО ЗМІСТУ


This has been made possible by the progress in the production and application of a specialized type of equipment — the compaction simulator, which can reproduce the mechanical movements of the tableting cycle of laboratory, pilot, and industrial presses at different speeds. In its basic configurations, this equipment allows precise measurement of punch displacement and the forces exerted under specific conditions. The results are converted into a vast dataset, and correct processing of this data, combined with instruments for measuring geometric dimensions and crushing strength, significantly improves scale-up efficiency and technology transfer. Furthermore, the compaction simulator enables determination of such a fundamental characteristic of powder materials as the mean yield pressure (an indicator of material plasticity) and the strain rate sensitivity. Given that the vast majority


of substances used in the development of innovative oral dosage forms are poorly soluble in aqueous environments (across the gastrointestinal pH range), and that more and more of them are losing patent protection, this has significantly influenced approaches to developing medicinal products with enhanced apparent solubility (to improve bioavailability), as well as formulation design, analytical, and technological equipment. The most widely used approaches to increasing apparent solubility are hot-melt extrusion (HME) and spray drying of organic solutions, predominantly polymer-based. These processes are often supplemented by spectroscopic PAT methods. In most cases,


the crystalline lattice of the active substance is disrupted, and it is stabilized in the form of an amorphous solid dispersion by a specifically selected polymer. Leading excipient manufacturers have already responded by developing special grades optimized for particular manufacturing methods, such as hypromellose for extrusion and polyvinyl alcohol for spray drying. To develop and control the quality of amorphous formulations, laboratories routinely use powder X-ray diffraction and differential scanning calorimetry (DSC). Depending on physicochemical properties, alternative approaches for poorly soluble active substances include lipid-based formulations (oil solutions, micro- and nanoemulsions, self-emulsifying systems), which may or may not undergo digestion depending on lipid composition. Prior to preclinical and clinical


studies, advanced dissolution testing with bicarbonate buffer (unstable but closer to intestinal conditions and more discriminative than widely used stable phosphate buffer, e.g., for enteric polymer-coated formulations) is increasingly employed. Biorelevant media, simulating gastrointestinal conditions in fasted and fed


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