Untitled

Abstract

The aim of the present research work was to develop a bilayer floating dosage form of immediate-release Atorvastatin (ATR) and sustained release Captopril (CPT) in matrix form for the treatment of hyperlipidaemia and hypertension to reduce multiple dosing frequencies and enhance patient compliance. ATR belongs to the BCS Class II category having poor aqueous solubility, which was enhanced by using hydrophilic polymer PEG 8000 by kneading technique. A sustained layer of CPT was prepared by melt granulation technique using various concentrations of carnauba wax with HPMC K 100 M and Carbopol 934 P. All the parameters before and after compression were evaluated. ATR-PEG ratio of 1:0.25 showed a higher drug release of about 97.42% within 60 min. The optimized CPT sustained layer SR2 shown the highest drug release 98.2% in 12 h. In-vitro drug release studies carried out as per USP in pH 1.2 buffer using type II apparatus. The CPT layer exhibited release kinetics in the first order and followed the diffusion and erosion mechanism. The FTIR, XRD studies, and SEM analysis indicated the absence of strong interaction between drug and polymer and compatibility among them. The novel concept of Bi-layer gastric floating can be utilized for the formulation of ATR and sustained release of CPT with a floating period of >12 h and 45 s lag time.