PHARMACEUTICAL DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY FOR PRODUCING MEDICINES BASED ON RED RASPBERRY LEAVES DRY EXTRACT

Abstract

The paper presents pharmaceutical development of the composition and technology for producing medicines based on a red raspberry leaves dry extract. When developing the composition and technology of tablets and hard capsules based on a red raspberry leaves dry extract it was proposed to produce tableted and powder mass using wet granulation and direct compression. To develop the composition of tablets and hard capsules using wet granulation the method of mathematical planning of the experiment was used: Latin square 3x3. The influence of the following factors on the quality of the obtained tablets and the contents of hard capsules was studied: disintegrating agents, excipients, concentration of binder solution. Disintegration time and compressive strength of tablets were used as optimization parameters and flowability of the powder mass for hard capsules was also evaluated. Significant effect on tablets disintegration of factors A and B (the nature of the excipient and the disintegrant) was stated. Duncan's multiple rank test was used to propose preference series within these factors. Compressive strength of tablets was not influenced by any factors studied. Based on the studies carried out the composition of the tablets and the contents of hard capsules with the use of wet granulation was proposed. The development of the composition and technology for obtaining tablets and the contents of hard capsules by direct compression and without wetting and granulation, respectively was made. It is proposed to use microcrystalline cellulose, lactose monohydrate and silicon oxide as additives to make direct compression which will improve technological characteristics of the tablet and powder mass and make it possible to produce tablets and the contents of hard capsules by direct compression and without wetting and granulation. This, in turn, will contribute to an increase in the microbiological purity of the tablets and the contents of hard capsules and increase labor productivity during their production. To increase the stability of tablets based on dry extract of red raspberry leaves water-soluble film coating is proposed.