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.
Highlights
The aim of any dosage form was to release the effective and precise amount of drug at the target site to give a desired pharmacological response
Delayed release system are systems used for repetitive and intermittent dosing of a drug from multiple immediate release units that is merged into a single dosage form [1]
Mini tablets are slightly curved or flat tablets which have diameter ranged between 1.0-3.0 millimeters; they can be filled into capsules
Summary
The aim of any dosage form was to release the effective and precise amount of drug at the target site to give a desired pharmacological response. Delayed release system are systems used for repetitive and intermittent dosing of a drug from multiple immediate release units that is merged into a single dosage form [1]. Mini tablets are slightly curved or flat tablets which have diameter ranged between 1.0-3.0 millimeters; they can be filled into capsules. Mini tablets can be compressed into larger tablets, and occasional it can be filled in sachets for easy administration [2]. The rationale of mini tablets formulation is to accomplish several releases in one formulation by combining altered dose. Mini tablets are formulated in the study to achieve the desired drug concentration in plasma is achieved [3]
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