Author(s): Yasmeen S, Ramesh T*, Ramesh M, Vasanth PM
The aim of present work is focused to develop an alternate vendor by comparative evaluation of excipients from different vendors and through their impact on identified formulations. Comparison of excipients from different vendors is based on a preliminary specification comparison, analytical results comparison and thorough evaluation of excipient based on its functional characteristics and later on a worst case formulation with respect to excipient tested is identified out of numerous formulations and the evaluated data is extrapolated for the rest of the formulations. Four excipients were identified based on their criticality and their functionality tests were developed based on their functional role in their respective formulations. From the observed results, it was concluded that the difference between the functional test results obtained from the existing and proposed source were less than 1 % for all the four excipients. From the results obtained it can be concluded that the proposed vendor materials for all the four excipients evaluated were equivalent with that of the existing vendor materials and therefore can be accepted as an alternate source.