Formulation and Development of Sustained Release Matrix Tablet of Ranolazine
Ranolazine is an anti-anginal drug used to treat chronic stable angina in adults. The main drawback with normal conventional dosage form is that the solubility of Ranolazine is relatively high at the lower pH (4.5 and below) and highly variable hepatic first pass metabolism following oral administration, with systemic bio-availability of 76% and Ranolazine also has a relatively short plasma half life of 2.5±0.5 hrs. in this investigation sustained release tablet were prepared by using partially neutralized pH- Dependent polymer HPMC90SH 4000SR, HPMC K4M, HPMC 15Cps and combination of polymer (HPMC K4M and HPMC 15Cps). By using different concentration of HPMC90SH 4000SR, HPMC K4M and HPMC 15Cps will better the dissolution rate and tablets were prepared by wet granulation method. Prepared tablets were evaluated for thickness, uniformity of weight, hardness, friability, drug content, invitro drug release. The invitro release of Ranolazine sustain release tablets was studied in 900 ml of 0.1 N HCl as dissolution medium using a USP dissolution paddle assembly at 50 rpm and 37±0.50C for 2 hrs, then release studies were conducted in pH 7.4 phosphate buffer for 24 hrs optimized formulation (F2) released 99.08% of drug for 24 hrs. The optimized formulation was subjected to stability studies for three month at 400C temperature with 75±5% RH and showed there was no significant change in drug content, physiochemical parameters and release pattern.