Abstract

DESIGN, DEVELOPMENT AND EVALUATION OF SUBLINGUAL TABLET OF CILNIDIPINE (ANTIHYPERTENSIVE) USING NATURAL SUPER DISINTEGRANT

Kishanpal Shakya*, Dr. Dilip Agrawal, Dr. Rakesh Goyal, Ashok Kumar Sharma, Mohit Khandelwal and Shaneza Aman

Abstract

Objective: In the present reported project study, the effect of Natural superdisintegrant was compared with synthetic super disintegrants and conventional super disintegrants in the Sublingual tablet formulation of Clinidipine. Cilnidipine is the novel dihydropyridine calcium antagonist and calcium antagonistic activity of clinidipine is long lasting than those of Nifedipine and Nicardipine. Cilnidipine has been used for the treatment of any hypertension and hypertensive-associated vascular disorders. Cilnidipine shows a very low solubility (BCS Class-II drug Low solubility high permeability) and compliance to the medication is always very poor The dissolution rate is directly proportional to solubility of drug. Methods: In the present work, 9 formulations of Sublingual tablets of Clinidipine were prepared by using natural superdiintegrants was evaluated and compiles with the official standards, parameters and specifications. Various formulations were prepared using three types of different superdisintegrant namely- Banana Powder, sodium starch glycolate, cross carmelose sodium with three concentrations (2%, 4%, 6%) by direct compression method. Result: The blend was evaluated for pre-compression parameters like Angle of repose, bulk density, tapped density, and then tablet evaluated post-compression parameters like thickness, drug content, hardness, weight variation, wetting time, friability, disintegration time, dissolution time, drug release study. Formulation SLT8 showed the lowest disintegration time and in-vitro dissolution studies recorded that formulation SLT showed Better drug release at the end of 3 minutes. Conclusion: The best formulations were also found to be stable and optimized formulations were subjected to the stability studies as per ICH guideline and standards.

Keywords: Sublingual tablet, Clinidipine, Co-proceed, sodium starch glycolate, Natural, Banana Powder direct compression, dissolution time.