Formulation, Development and Characterization of Bilayer Tablet for the Treatment of Hyperlipidemia

Abstract

The present experimental work was carried out to formulate, develop and characterize a generic formulation for the EU market. The formulation entails two immediate release layers of a dosage form for a BCS class II anti-hyperlipidemic agents with low solubility. The major challenges for formulating this formulation are the drug release and adjustment of the ratio between two layers of the drug substance. The first issue of low solubility was addressed by incorporating the surfactant, sodium lauryl sulphate in first layer and polysorbate 80 to the second layer. The second issue of drug release was addressed by adding super disintegrant into intra and extra granular part. The third issue of adjustment of ration of two layers was addressed by setting the weight of each layer. Preliminary studies on the drug product were started with literature search to understand the intricacies of the formulation and the method of analysis. The next step in the process was to characterize the RLD product. Similar excipients as the RLD product were used in the generic drug product development. Preformulation studies were carried out to check API-excipients compatibility. After obtaining satisfactory preformulation results, development batch trials were conducted. Varied IPQC tests were conducted to obtain an optimized formulation similar to the RLD product. F1 and F2 similarity was done to check the percentage of similarity between the RLD product and the developed product. The drug product successfully passed the accelerated stability studies. The developed drug product is found to be scalable and marketable in the near future.