Effect of super disintegrating agents on imatinib tablets by in vitro drug release study using kinetic model

Abstract

The major problem in Imatinib drug formulation is high half-life which mainly results delay in peak plasma concentration. The concept of formulating fast dissolving tablets by super disintegrates offers a suitable practical approach for faster disintegration and dissolution characteristics. Among the various method of preparations fast dissolving tablets were prepared by using super disintegrates like croscarmellose sodium, cross povidone, sodium starch glycol ate by direct compression. The prepared Imatinib tablets were evaluated for free compression parameters like angle of repose, bulk density, tapped density, carr’s index and post compression parameters like hardness, friability and weight variation, drug content uniformity, disintegration time and In-vitro dissolution studies. Among various fast dissolving tablets of Imatinib, F9 formulation shows maximum drug release of 30min (100.3%). The tablets of different formulations were subjected to various evaluations tests such as Hardness, Friability, and uniformity of weight, drug content and in vitro – dissolution. In a weight variation test, the pharmacopoeia limit for the percentage deviation for tablets above 324mg is ±10%. The average percentage deviation of all tablet formulations was found to be within the limit, and hence all formulations passed the test for uniformity of weight as per official requirements. Good uniformity in drug content was found among different batches of the tablets, and the percentage batches of drug content were more than 98%. In the present study, the percentage friability for all the formulations was below 1%, indicating that the friability is within the prescribed limits. All the tablet formulations showed acceptable pharmacopoeia limit specifications for weight variation, drug content, hardness and friability.