COMPARATIVE EFFECT OF DIFFERENT HIGH FUNCTIONALITY EXCIPIENTS ON VARIOUS CHARACTERISTICS OF VARDENAFIL HCL TABLETS (BCS II DRUG)

Direct Compression is becoming a preferred manufacturing process in order to speed up the manufacturing and reduce costs. Although a major requirement for direct compression process is selection of excipients with the optimum physical characteristics that increase final flowability and compressibility of the ready for compression (RFC) tableting blend. By using combinations of excipients and novel processing techniques, particles / excipients can be engineered to deliver desired properties to be used in direct compression. The resulting engineered excipients are commonly known as “coprocessed,” “high functionality,” “multifunctional,” “high functionality,” “performance” excipients. Prosolv Easytab SP and Panexcea™ MHC 300G are amongst this type of high-functionality excipients, which are used in present study to check their comparative performance on compression of tablets using direct compression technique with use of BCS class– II drugs such as Vardenafil HCl (5 mg). The drug was characterized using Infra-red spectroscopy. Pre-formulation, solubility and drug-excipient compatibility studies were carried for drug substance. While for all individual batches, blend analysis and various IPQC parameters such as tablet hardness, friability, disintegration, weight variation and uniformity of thickness were analysed. In-vitro release for the drug was also studied, the results from tablets of both batches using different high-functionality excipients were optimum and satisfactory and use of such high-functionality excipient is favourable in order to enhance efficiency with reduction in both time and cost of process.