Formulation and development of lenalidomide loaded delayed release mini tablets in capsules

Abstract

Objective: Formulation and development of delayed release mini tablets in the capsule of drug lenalidomidein terms of dissolution and stability was the objective of the present work. Methods: Tablets of less than or equal to 3 millimetres diameter are Mini-tablets, which were filled into a capsule. Direct compression method using multi-tip punch was used for compression and coated with eudragit L100 as a seal coating material and with eudragit L30D55 as an enteric coating material was done. Different formulations were prepared and subjected for evaluation like weight variation, hardness, friability, disintegration, and dissolution studies. The optimized formulation was compared to marketed product based on drug released profile and also subjected for stability studies. Results: The results revealed that the in vitro drug release of prepared formulations, F1, F2, F3, and F4 was subjected for acid resistance test for 2 h in 0.1N HCl and has a comparable dissolution profile in phosphate buffer of 6.8 pH. FormulationF4 was subjected for stability studies and no significant difference was observed in 3 mo 40 °C/75% RH accelerated stability condition. Conclusion: The dissolution profile of formulation F4 was found better than that of market product. Based on evaluation results, the study concluded that F4formulationwas considered as an optimized formulation.