DESIGN AND DEVELOPMENT OF NIFEDIPINE BILAYER TABLET

Nifedipine is a calcium channel blocker, used in treatment of moderate to severe angina and hypertension. It is under goes extensive first pass metabolism resulting in an oral bioavailability of 45 % and it shows variable absorption from GIT. Bilayer tablet is improved benefi cial technology t o overcome the shortcoming of the single lay ered tablet. It offers several advantages such as rapid absorption, reducing peak plasma fluctuation and ease of administration. It is suitable for sustained release tablet in which one Layer is immediate release as initial dose and second lay er is maintenance dose. In present study, Bilayer Tablet was prepared using optimized combination of Nifedipine and hydrophollic polymers (HPMC K15M and K100M). HPMC is one of the most widely used hydrophilic polymer having Generally Recognized As Safe (GRAS) and easily available in all the grades. HPMC is available in various viscosity grades out of which K15M and K100M was selected as release retarding agent in Nifedipine. Sodium starch glycolate (super disintegrator) was used in the part to give immediately release effect of Nifedipine. Among different trials with wet granulation, batch B8, B10, B11, B12 and B14 for Nifedipine SR part & batch A12 for Nifedipine IR part showed no evidence in drug polymer interaction.