Design and Optimization of Tramadol HCL immediate release tablets as per scale Up and Post Approval Changes (SUPAC) Level II

The Filing of a New Drug Application (NDA), Abbreviated New Drug Application (ANDA) and Abbreviated Antibiotic Drug Application (AADA) is only the beginning for a drug to get into the market. The SUPAC Level changes are due to change in site, change in excipient levels, changes in batch size and equipment changes. The objective of this experiment was to make a robust, stable formulation which would withstand the SUPAC changes. An immediate release tablet formulation was made in order to carry out the proposed changes in excipient levels. A prototype formula of the immediate release tablet was prepared which was then subjected to SUPAC Level 2 changes – Binder ± 1 % (B1 and B2), Disintegrant ± 2 % (D1 and D2), and Lubricant ± 0.5 % (L1 and L2). These were observed for changes in physical parameters and the dissolution was also carried out. It was inferred through the observations, that L1 variant with less lubricant showed sticking and picking and the L2 variant showed slower dissolution profile. Thus, knowing the effect of change of excipient beforehand can lead to savings in raw material cost, labour cost and avoidance of unnecessary batches.