Abstract
Diabetes mellitus (DM) and hypertension are two common diseases that often coexist. The most common cause of death in the diabetic patient is heart disease. In the present investigation we combine Nebivolol and Nateglinide for better patient compliance. IR layer was formulated using various superdisintegrants like Crospovidone, Croscarmellose sodium, and sodium starch glycolate and SR layer was formulated using polymers and gums like HPMC E15, ethyl cellulose, Gaur gum, and Xanthan gum. The disintegration and dissolution study of both layers showed that inclusion of surfactant (sodium lauryl sulphate) to the tablet formulation (IR) and dissolution medium (SR) enhanced the release of drugs from both layers. Kinetic studies of optimized IR layer (NBL8) and SR layer (N9) showed good linearity with regression coefficient of 0.9714 (Higuchi model) and 0.9931 (zero order kinetics), respectively. The above results reveal that the optimized IR layer of Nebivolol (NBL8) and SR layer of Nateglinide (N9) might be suitable for the treatment of diabetes and hypertension by sequential release of the two drugs in a bilayer tablet. IR-immediate release, SR-sustain release, NBL8-Nebivolol 8, N9-Nateglinide 9.
Highlights
Diabetes mellitus (DM) and hypertension are two common diseases that often coexist
The above results reveal that the optimized IR layer of Nebivolol (NBL8) and SR layer of Nateglinide (N9) might be suitable for the treatment of diabetes and hypertension by sequential release of the two drugs in a bilayer tablet
Calibration curves were plotted for both Nebivolol and Nateglinide based on the data obtained in UV spectrophotometer and these curves showed regression coefficient of 0.9999 and 0.9996 for the respective drugs
Summary
Nateglinide and Nebivolol were obtained as gift samples from Hetero Drugs Ltd. Hyderabad, India. The immediate release Nebivolol layer was placed in the die cavity and allowed for punching with optimum hardness of 6–8 kg/cm to form bilayer tablets. The prepared tablets were subjected to various evaluation tests like thickness, hardness, weight variation, friability, and drug content. The release of drug from different batches of prepared tablets was studied using USP dissolution apparatus type II. In vitro drug release studies of bilayer tablets were carried out uvusing USP dissolution apparatus type II in 500 mL of 0.1 N HCl for first 30 minutes and in 900 mL of 0.01 N HCl with 0.5% SLS up to 12 hours. The drug release kinetic studies were carried out for bilayer tablets of Nebivolol and Nateglinide and were evaluated using the linear regression method:. The products were evaluated for their physical characteristics and in vitro drug release profiles over a period of 3 months
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