Dissolution Enhancement of Indomethacin through Binary and Ternary Solid dispersions and Inclusion Complexes – A Comparative Evaluation

Abstract

Dissolution of drugs is a prerequisite in the development of their oral dosage forms with satisfactory bioavailability. In this investigation, solid dispersion of the model drug indomethacin in gelucire (50/13) and inclusion complexation in sulfobutyl ether beta cyclodextrin are employed to enhance the dissolution. Fast dissolving products (F1-F8) of indomethacin are prepared by different methods such as solvent evaporation, freeze drying and kneading and comparatively evaluated. The ternary and binary systems of the products are prepared and evaluated for their efficiency in increasing the dissolution. The dissolution efficiency values (DE30) were found to be higher for solid dispersions (73.34%) and inclusion complexes (53.12%) than the pure drug indomethacin (3.32%). The x ray diffraction and differential scanning calorimetry studies revealed that the crystalline drug is converted into an amorphous form in the dispersions and inclusion complexes. Soluplus and gelucire are employed as ternary components in the solid dispersions and inclusion complexes respectively and are found to be resulting in ternary systems which were found to be superior to the binary systems. A 22 full factorial experimental design in order to investigate the combined influence of method of preparation and nature of the product. It was observed that the method of preparation and nature of the product (a ternary system or a binary system) will influence the extent of improvement of dissolution of the drug.