DISSOLUTION TESTING MEFENAMIC ACID CAPLET AND CAPSULE USING INDONESIAN PHAMACOPOEIA - UNITED STATES PHARMACOPOEIA, PHARMACOPOEIA OF THE PEOPLES REPUBLIC OF CHINA AND BIORELEVANT (FASSIF) MEDIUM

• Main Author: Nurhikmah, Wilda
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78635
• Institution: Institut Teknologi Bandung

Mefenamic acid is non-streroidal anti-inflammatory drugs (NSAID), widely used for treat mild to moderate pain. Mefenamic acid is belong to Biopharmaceutical Classification System (BCS) class Il, which has low water solubility but high permeability. There were differences between medium and the method of mefenamic acid dissolution test in Indonesian Phanhacopeia ed V (FI), United states phannacopeia 37 (USP) and Pharmacopoeia of the People's Republic of China 2010 (RPC). The medium used for dissolution test in the compendia was not relevant human physiology. The biorelevant medium is the medium simulated of human intestinal fluid or gastric fluid. The aim of this research is to study dissolution profile mefenamic acid from Indonesian market with three different medium such as FI-USP medium, RPC medium dan biorelevant fasted simulating small intestinal fluid (FaSSIF) medium. Dissolution test of mefenamic acid caplet was performed ini 900 mL of medium by using apparatus Il (paddle) at temperature 37oc and rotation speed 75 rpm, while dissolution test of capsule was done in 900 mL of FI-USP medium by using apparatus I (basket) at 370C and rotation speed of 100 rpm. The result obtained from solubility test showed that the best solubility of mefenamic was in FI-USP medium, The dissolution of ML capsule can fulfill the requirement in the FI-USP medium. The result from dissolution test in RPC medium, show that mefenamic acid dissolved from inovator (PN caplet) and generic products (GN caplet, ML caplet and ML capsule) were met the requirement. Meanwhile the amount of mefenamic acid dissolved in FaSSIF biorelevant medium for all tested sample were not more than 17%. ML caplet asa generic product was similar with caplet PN in RPC medium with P = 65. Dissolution effciency in FI-USP medium is better than RPC and biorelevant FaSSIF medium.