Published Paper Details:

The study aimed to develop sustained-release floating tablets of Tapentadol HCl utilizing a direct compression method with an effervescent approach. Poly ethylene Oxide (Polyox WSR 301, Polyox WSR 303, Polyox WSR 308) was chosen as the sustained-release polymer, while sodium bicarbonate served as the gas-generating agent. Preformulation study of API was performed using FTIR Spectroscopy. Drug excipient compatibility shows no interaction between drug and excipients. Trial batches initiated for screening of polymer. Prepared tablets were analyzed for various parameters like weight variation, hardness, thickness, friability, swelling and drug content, In-vitro drug release extended to 12 hours, with formulation T9 demonstrating 99% drug release, hence choosen for optimization using factorial design was done using DOE software. Factorial batches (F1-F9) with Polyox WSR 303, Sodium bicarbonate as Indipendent Variables showed significant outcomes. Factorial batch achieved desired drug release. Batch O1 was fine-tuned for drug release 99% over 12 hours and Floating Lag time 37 seconds. Higuchi's model fit best. The optimized batch O1 was subjected for Stability study and found stable for 1 month. Hence, O1 batch was the optimized batch.