Formulation and Evaluation of Obeticholic Acid Solid Dispersion Tablet

Abstract

Obeticholic acid is a farnoside X receptor agonist that was recently licenced by the US Food and Drug Administration. In a solvent, solubility is lower, therefore it is necessary to improve solubility. Solid dispersion is one of the most effective methods for increasing Obeticholic acid's solubility. Solid dispersion can be prepared in a variety of ways. Fusion (Hot Melting) is one of the most straightforward and cost-effective methods for producing solid dispersion. Poloxamer is one of the finest polymers for solid dispersion production. Poloxamer 188 and Poloxamer 407 are widely accessible. Above solid dispersion is made using the fusion or hot melting procedure. The solubility of the prepared solid dispersion has increased to 0.347 mg/ml. In comparison to the polymer combination, which has a drug release rate of 99.63 percent, the percent drug release is also superior. Precompression settings were found to be within a reasonable range. Post compression parameters such as Hardness, Friability, Uniformity of weight, content uniformity are in standard range. F7 formulation shows 99.63 ± 0.19 in 60 minutes of time. Phosphate buffer 7.4 is used for dissolution test apparatus. All result parameter shows that prepared solid dispersion of Obeticholic acid by using poloxamer gives improved solubility and increased drug release.