NIFEDIPINE SUBLINGUAL TABLETS: FABRICATION USING SUPER DISINTEGRANTS AND THEIR EVALUATION
Manasa N. M.*, Prathibha C. and Sudha B. S.
The aim of present research was to develop sublingual tablets of nifedipine (a calcium channel blocker used as an antianginal and antihypertensive drug) by complexing with ?-cyclodextrin and drug-carrier solid dispersion to improve its solubility and bioavailability. Sublingual route is most widely used method to improve the bioavailability, by enhancing drug to completely disintegrate. Thus it delivers the drug particles from the dosage form directly into the systemic circulation by avoiding the first pass metabolism. Sublingual tablets of nifedipine (23 batches) using polymers like CP, SSG, CCS at different concentration and combination were prepared by direct compression and wet granulation techniques. To improve the solubility, drug was complexed with ?-cyclodextrin and drug -solid dispersion using PVP-K30/PEG4000.The results of pre-compression parameters were in acceptable range as per specifications given in the IP. Prepared tablets were evaluated for thickness, uniformity of weight, hardness, friability and the results are within the IP limits. Out of 23 formulations tablets contained 5% of CP and 3% of SSG(NF9) showed low wetting time 17sec, low in vitro disintegration time 15sec, high water absorption ratio 37.94% and high drug release profile 92.7%. Further complexation of NF9 at 1:4 drug: ?-cyclodextrin ratio had shown improved wetting, in vitro disintegration and water absorption which enhances the in vitro release (NF 19). The stability studies were done for optimized batch F9 and F19 by storing at 400C±20C / 75% ±5% RH up to 90 days. After 90days there was no significant changes in the tablets was observed.[Full Text Article]