Development of composition, technology and determination of quality indicators of medicinal films with etoricoxib

Abstract

According to the Strategy for the Development of the Pharmaceutical industry until 2030, the development of new domestic medicines is one of the urgent tasks to ensure sustainable socio-economic development of the Russian Federation. In this regard, we have developed the composition and technology of a drug in the dosage form of a “Film”, dispersed in the oral cavity, with a nonsteroidal anti-inflammatory agent of selective action – etoricoxib. The choice of this dosage form is due to its advantages over other dosage forms, such as high bioavailability, no need to wash down the films with water and swallow, the prevention of the development of undesirable adverse reactions from the gastrointestinal tract.

The purpose of the study was to verify the compliance of the manufactured model samples of films with etoricoxib with the requirements of the State Pharmacopoeia of the current edition. The article presents data on the development of the optimal composition of films and the method of selecting the concentration of preservative, the technology for producing films, as well as describes the processes and results of tests conducted to assess the quality of films according to some regulated indicators in accordance with the GPA “Films”, such as description, film dimensions, pH of the solution, uniformity of mass, microbiological purity.

The results of the scientific work showed that the developed drug with etoricoxib meets the requirements of the General Pharmacopoeia Monograph “Films” for the quality indicators studied.

Keywords

biodegradable film / etoricoxib / formulation development / medicinal film / microbiological purity / pain relief / quality assessment

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