EXTEMPORAL MANUFACTURE OF MEDICINES. PROBLEMS AND SOLUTIONS

Abstract

Despite the decrease in the number of pharmacies having prescription and manufacturing departments the need for extemporally manufactured dosage forms remains high. Pharmaceutical organization dealing with medicines manufacture is currently facing a number of problems: lack of modern pharmaceutical substances at pharmacies, manufacture of medicines containing narcotic substances, psychotropic substances and their precursors, high costs, low profitability of in-pharmacy manufacture and etc. The urgency to preserve and revive ex tempore formulations at pharmacies is highlighted. The groups of patients for whom individual manufacture of medicines is most relevant are identified: children, especially newborn and children under 1 year old, elderly patients, as well as patients with orphan diseases and patients requiring palliative care. The advantages of the extemporal formulation are noted, in particular, the selection of an individual composition and dosage taking into account body characteristics, age, concomitant diseases of the patient, tolerance of medicinal substances and their excipients, etc. Some ways to solve problems arising are suggested. Promising directions for the development of extemporal manufacture are noted: the use of modern excipients, technologies, packaging facilities, the development of internal regulatory documentation for the pharmaceutical quality system and etc.