Formulation and Evaluation of Transdermal Patch of Apixaban

Abstract

The aim of the present investigation was to develop and evaluate transdermal patch of Apixaban. Formulation development of\nApixaban Transdermal patch was initiated using Eudragit S 100 and HPMC E50 LV as matrix controlling polymer for matrix type\nTransdermal Patch. PEG 400 was selected as plasticizer. Glycerin was selected as permeability enhancer. Preformulation study was\nperformed to check the drug excipient compatibility. The IR spectra of Drug and final formulation found satisfactory. There are no\nany interaction between drug and excipients. Further the linearity curve was developed in UV for method of analysis. Trials A1-A14\nwas initiated using different concentration of polymers in the formulation. The prepared patches were transparent and smooth in\nsurface. The weight variation was found well within acceptable range. The thickness of patches was found uniform in nature and the variation is found satisfactory. Further, the surface pH of the patches was found between 6.8 to 7.1 and it is acceptable. The drug\ncontent, folding endurance and %elongation results of A1-A14 batches were found well within acceptable range. Initially the trial\nbatches were taken with a single polymer like HPMC and EudragitS100. The drug release was not achieved as per the target drug release profile for 8hours. Hence the combination of these two polymers are taken and found better results than the single polymers. Based on the drug release data, it was observed that the A8 batch was the most satisfactory batch with respect to drug release and other parameters. Hence, the A8 batch selected as optimized batch and Stability study of the same batch initiated.