Suresh Karudumpala, Gnanaprakash K, Venkatesh B, Sankar P, Balaji G, Vidya Sagar N
Nifedipine is a calcium channel blocker of the dihydropyridine type, mainly used for the treatment of hypertension and angina pectoris. Nifedipine is a suitable candidate for Controlled Release administration due to its short elimination time 2-4 hrs. The aim of present investigation is to increase the gastric residence time by preparing gastro retentive floating bilayered tablet thereby improving bioavailability. A simple UV spectro photometric method has been employed for the estimation of nifedipine at 238 nm with a Beer’s range of 0-10μg/ml. Fourier transform Infrared spectroscopy confirmed the absence of any drug/polymers interactions. Ten formulations (F1 to F10) were prepared using various polymers such as HPMC K4 HPMC K15, Carbopol and Sodium Carboxy methyl cellulose in different ratios. Direct compression method was adapted to compress bilayer floating tablet. The prepared floating bilayer tablets were evaluated for hardness, weight variation, thickness, friability, drug content uniformity, buoyancy lag time, total floating time, water uptake (swelling index) and in-vitro dissolution studies. All the formulation showed drug release ranging from 89.19% to 98.08 and drug content ranging from 96.10 to 101.2%. Formulation F7 has shown maximum drug release with good physical integrity upto 16hr in pH 1.2. Kinetic study shown F7 release exponent (n) value is within permissible limits. It indicated that, the release mechanism for F7 may by diffusion mechanism followed by non-fickian transport. F7 selected as best formulation which contains HPMC K4M and Carbopol. Accelerarated Stability studies revealed that F7 were stable when stored at room temperature as well as different accelerated temperature and humidity conditions for a period of six months. The values were within permissible limits.
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