Editorial Pharmaceutical Industry Review, October No 2 (105) 2025
Valentyn Mohylyuk, PhD (pharm. sci.), Guest Editor of the issue dedicated to solid dosage forms
Editorial Від редактора
We are all familiar with metaphorical expressions such as “movement is life” or “movement is the meaning of life.” These can be easily applied to our pharmaceutical industry and its professionals — from workers to managers of enterprises and institutions, and from students to lecturers and researchers. Despite everything, our world, together with the pharmaceutical industry, is constantly moving forward. Research on new medicinal products is ongoing, and several dozen new/innovative drugs enter the global market (in the USA and Europe) each year. Approximately the same number of drugs lose patent protection annually, which serves as a vital “infusion”
of life force for generic companies and as a
foundation for their competition. In the time that passes between the patenting and market launch of innovative medicinal products and the expiration
of patent exclusivity, the world accumulates substantial experience in both breakthrough and incremental innovations in synthesis methods and technologies; analysis, including analytical equipment; logistics approaches adapted to today’s challenges; formulation design and composition development; implementation of drug manufacturing technologies and new excipients (enhancing productivity and quality, increasing shelf-life, and even enabling the previously impossible); new and improved technological equipment; packaging materials and technologies, and more. It seems like only yesterday we were discussing Pharma 4.0 as something exotic, while today, for many companies, movement in the context of or toward this paradigm has already become an everyday norm. This includes automation, digitalization, quality knowledge management, requirements for products and processes, process
understanding and control, and control strategies to achieve the desired outcome. Considering the focus of this
issue dedicated to solid dosage forms and their technological, equipment-related, analytical, and organizational solutions, I would like to draw your attention to several important and interrelated trends. Continuous manufacturing, inherently linked with the use of process analytical technologies (PAT), is steadily gaining popularity due to the avoidance of scale-up challenges, flexibility in batch sizes, the ability to influence the technological process, reduction of off-specs, smaller production facility footprints, and more. There are already known cases where, under specific technological process conditions (including tableting), thanks to pre-established correlations, the drug release profile can be reliably predicted, eliminating the need for routine control. Big Pharma not only develops new drugs using continuous manufacturing but also transitions certain existing products to this method. To illustrate the real situation, it should be noted that, according to my information, via continuous manufacturing (from raw material loading to the final dosage form), for example, Pfizer produces only two medicines, while GSK
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