Development of a target quality profile for capsules containing a dry extract of salvia sclarea l. grown in tajikistan

Abstract

Aim. To work out the concept of scientific research on the pharmaceutical development of capsules based on the substance of a dry extract of Salvia sclarea L. (clary sage) grown in Tajikistan by developing a target drug quality profile.
 Materials and methods. During the research, methods of a systematic approach, scientific analysis, comparison, analogy, and generalization of information on the pharmaceutical development of herbal medicines were used. Tabular and schematic tools for visual presentation of the data obtained were also applied.
 Results. The pharmacological studies of a dry extract of Salvia sclarea L. grown in Tajikistan using the “elevated plus maze” test indicate the prospects of its use as an active substance of a moderate anxiolytic action in the dose of 300 mg/kg. The results obtained served as the basis for developing a target quality profile for capsules containing a dry extract as the first stage of the pharmaceutical development, implementing the programmable quality concept “Quality by Design”. When developing the target quality profile for capsules, a set of complementary provisions, recommendations, and methods of the State Pharmacopoeia of Ukraine and the Eurasian Economic Union concerning the issues of technological, chemical, and microbiological requirements for the development of pharmaceutical products was analyzed.
 Conclusions. Thus, the development of a target quality profile for capsules containing a dry extract of Salvia sclarea L. will make it possible to rationally use material resources and implement the programmable quality concept.