SOLID DISPERSION OF ORAL CANDESARTAN CILEXETIL TABLETS FOR HYPERTENSION: DEVELOPMENT AND CHARACTERISATIONAbstract
The main aim of this study was to prepare solid dispersion of Candesartan cilexetil so as to improve its solubility and dissolution characteristics in order to enhance its oral bioavailability. Solid dispersion was formed by fusion method. 9 formulations (F1-F9) were prepared using different carriers i.e. Sorbitol, Polyethylene Glycol (PEG 6000) and Poloxamer 407 at different ratios of 1:1, 1:3, 1:5 each. Out of 9 formulations, F3, F5 and F9 formulation compositions were selected on the basis of solubility, % yield, drug content, in-vitro dissolution studies. F3, F5 and F9 formulations were further formulated in 3 batches (A, B, C) into conventional dosage forms (tablet) with ingredients such as lactose, SSG, MCC, magnesium sulphate, and talc. On the basis of physical and chemical evaluation (Disintegration and dissolution studies), F9 was considered as the optimized formulation. The Optimized formulation, F9 i.e. Batch C was further compared with the Marketed formulation (Atacand, 4 mg) and stability studies were performed according to ICH guidelines. The optimized formulation of solid dispersion of Candesartan cilexetil (F9) has showed tremendous solubility, dissolution as well as other characteristic and can be used for hypertension and explore, further.
P. Verma, B. Singh and H. Chaudhary*
Department of Pharmaceutics, P. D. Memorial College of Pharmacy, PDM University, Bahadurgarh, Haryana, India.
15 December, 2016
21 July, 2017
27 October, 2017
01 November, 2017