EUTECTIC MIXTURES STUDY OF PIROXICAM AND MALIC ACID

• Main Author: Annisa Fauzi, Nadine
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78414
• Institution: Institut Teknologi Bandung

Piroxicam is an active drug substance that belongs to the Non-Steroidal Anti-Inflammatory Drugs (NSAID). Based on its solubility, piroxicam is include in the Class II of Biopharmacutical Classification System (BCS) drugsthat are poorly soluble and highly permeable. One of the waysthat can be done to improve these properties of piroxicam is by forming an eutectic mixtures with other compounds. This study aims to learn the physicochemicals characteristic especially dissolution rate that occur in the formation of eutectic mixtures of piroxicam. Malic acid is chosen as an additive that used to form an eutectic mixtures with piroxicam according to the results of the Cambridge Structural Database (CSD) screening in previous studies. The manufacture of eutectic mixtures is done through the dry mortar grinding method and the LAG method. The results of preliminary test using contact method show solids interactions such as eutectic interactions. Binary phase system diagrams shows the composition of the piroxicam-malic acid binary mixture with ratio (3:7) has the lowest melting point at range 121,5 – 129 °C so that its composition determined as an eutectic mixture. The eutectic mixture was characterized using X-ray diffraction analysis and evaluated by dissolution test. The results of X-ray diffraction analysis confirmed the absence of new compounds formed in the eutectic mixture. The diffractogram of the eutectic mixture (3:7) of the two manufacturing method has a combined typical diffraction peak of pure piroxicam and pure malic acid around the diffraction angle of 2? such as, 8,64°; 11,66°; 14,46°; 17,7°; 20,07°; 21,74°; 23,54°; 25,83°; 26,74°; 27,37°; 32,76°; 37,46°; and 40.8°. The analysis results of the f1 (difference factor) and f2 (similarity factor) dissolution test showed that the dissolution of the eutectic mixture (3: 7) with the mortar milling method was not similar to the dissolution of the active substance piroxicam and there was an increase in dissolution in the medium with pH 4.5.