Preparation and Characterization of Novel Co-Crystal Forms of Fexofenadine

By the improving physicochemical properties of Active Pharmaceutical Ingredient (API) such as solubility, stability and bioavailability Pharmaceutical co-crystallization techniques has gained a lot of attention. A pharmaceutical cocrystal is a single crystalline solid that incorporates two neutral molecules, one being an active pharmaceutical ingredient (API) and the other a co-crystal former. The present investigation involves formulation and solubility enhancement of a cocrystal based solid dosage form consisting of a stoichiometric amount of parent drug Fexofenadine with a pharmaceutically acceptable co-former Tartaric acid. Firstly co-crystals are prepared through Solvent evaporation method by taking Fexofenadine and Tartaric acid in 1:1 ratio. Co-crystal formation is confirmed by infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), Microscopic studies. The supramolecular interaction of fexofenadine with dicarboxylic acids resulted in formation of hydrogen bonding between them. Prepared Co-crystals are subjected to Preliminary pharmaceutical characterization such as solubility, Drug content, percentage yield and Invitro dissolution studies. DSC, SEM and FTIR analysis confirm the formation of molecular complex. When compared to the formulation of Fexofenadine the formed cocrystal has shown max drug release of 86.9% with 0.01 N HCL as a dissolution medium. From the pharmaceutical characterization, prepared molecular complex has shown increased solubility and increased drug release profile.