PHARMACEUTICAL PROFILE CHARACTERIZATION OF TELMISARTAN HYDROCHLORIDE TRIHEMIHYDRATE AND ANHYDRATE TABLET

• Main Author: Novia, Jellyn
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/82677
• Institution: Institut Teknologi Bandung

Telmisartan is an antihypertensive drug categorized as Biopharmaceutical Classification System class II, indicating it has low solubility. The conversion of telmisartan into its salt form using hydrochloric acid successfully formed telmisartan hydrochloride trihemihydrate (TEL-HCl trihemihydrate) and telmisartan anhydrate (TEL-HCl anhydrate). These salts have been proven to enhance the solubility and intrinsic dissolution rate of telmisartan. This study aims to compare the pharmaceutical profiles of TEL-HCl trihemihydrate and TEL-HCl anhydrate salts formulated into tablets. Both salts were prepared using the solvent evaporation method and characterized by polarized micrscopy, TG-DTA, PXRD, and SEM. Both types of salts were tableted using direct compression and wet granulation methods. The resulting tablets were evaluated for flow rate, particle size distribution, disintegration time, friability, dissolution rate, and content determination. The results showed that the the dissolution rate of TEL-HCl anhydrate tablets made by direct compression was 1,12x higher compared to TEL-HCl trihemihydrate. The production of TEL-HCl trihemihydrate and TEL-HCl anhydrate tablets using the wet granulation method resulted in the tablets with similar characteristics. In the wet granulation method, the dissolution rate of TEL-HCl anhydrate tablets was 6,05x higher than TEL base tablets.