Formulation and Evaluation of Controlled Release Matrix Tablets of Selexipag

Abstract

Abstract The objective of the present study was to develop a Controlled release matrix tablets of Selexipag, an anti hypertensive drug. The Controlled release tablets were prepared by wet granulation and formulated using different drug and polymer ratios, formulations such as F1 to F9. Hydrophilic polymer like Hydroxypropyl methylcellulose (HPMC), hydrophobic polymer like Ethyl Cellulose(EC) and natural polymer like Xanthan Gum(XG) were used. Compatibility of the drug with various excipients was studied. The compressed tablets were evaluated and showed compliance with Pharmacopoeial limits. The optimized formulation(F3) on the basis of acceptable tablet properties and in vitro drug release. The resulting formulation produced robust tablets with optimum hardness, consistent weight uniformity and friability. All tablets but one exhibited gradual and near completion Controlled release for Selexipag, and 96.45% released at the end of 10h. The results of dissolution studies indicated that formulation F3 (drug to polymer 1:1.5), the most successful of the study, exhibited drug release pattern very close to theoretical release profile. A decrease in release kinetics of the drug was observed on increasing polymer ratio. Applying exponential equation, all the formulation tablets(except F3) showed diffusion-dominated drug release. The mechanism of drug release from F3 was diffusion coupled with erosion.