Lyapunov O. Pharmaceutical development, studies and standardization of medicinal product Meloxicam gel

The crystalline structure of meloxicam, its particle size and solubility as well as the solubility of its salt with trometamol have been investigated. The composition of the mixed solvent as well as a carbomer for the formation of the gel have been chosen. It has been shown that in experiments in vitro dissolved meloxicam has released from gels; the gel structure does not influence the release of meloxicam and penetration enhancers, because the dispersion medium remains liquid. In the experiment, meloxicam from the gel slowly and protractedly was absorbed through the skin; the analgesic effect increases with the content of meloxicam, and the anti-inflammatory effect is greatest at its content of 1,0-1,5 %. These effects also depend on penetration enhancers. The medicinal product Amelotex® gel 1 %, the methods of its analysis and the production process have been developed, the quality attributes of the product have been standardized and the physicochemical properties have been investigated, the choice of primary packaging has been substantiated. The medicinal product meets criterion A in regard to the effectiveness of antimicrobial preservatives. The registration documents have been developed, the drug was registered and introduced into industrial manufacture with concurrent process validation