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ISSN 2063-5346
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FORMULATION AND EVALUATION OF BILAYER TABLET OF METFORMIN HCL AND ENALAPRIL MALEATE

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Pramod S. Biradar 1*, Sujit S. Kakade 2 , Ashok V. Bhosale 3 , Prashant H. Khade4 , Trusha P. Shangrapawar5 , Vishal B. Mahajan1 , Amol B. Rokade1 , Ruchita A. Bhalerao1
» doi: 10.48047/ecb/2023.12.si5.369

Abstract

The present research work was to establish the bilayer tablet of Metformin HCl and Enalapril Maleate for patients having Diabetes Mellitus and Hypertension. The bilayer tablet of Metformin HCl and Enalapril Maleate was developed by direct compression method. The bilayer tablet contained the Sustained release layer of Metformin HCl and Immediate release layer of Enalapril Maleate. The SR layer of Metformin HCl developed by using the HPMC K4M and HPMC K100M for controlled release of drug. While, the IR layer of Enalapril Maleate was developed by using Croscarmellose Sodium (CCS) and Sodium Starch Glycolate (SSG). The pre-compression study was performed and the results were reported. In pre-compression study the angle of repose, bulk density, tapped density, Hausner’s ratio and Carr’s index was calculated and results shown the good compliance as per IP standards. The tablets parameters were evaluated by testing thickness, hardness, weight variation, friability test etc. The % drug content was found to be in the range of 97.7±0.33 to 99.12±0.56 for SR layer of Metformin HCl and for IR layer Enalapril Maleate was found to be 97.03±0.62 to 99.53±0.35. The disintegration time for IR layer was found to be 45.31±0.39 to 78.27±0.55 sec. The formulation F3 shown the best results of dissolution study containing IR3 and SR3 layer of Croscarmellose and HPMC K4M respectively. The IR3 layer of F3 formulation shown 98.93±0.37 % drug release at the end of 40 min. and which was the best drug release than other formulations. The SR3 layer of F3 formulation shown the controlled drug release for 12 hrs. with maximum drug release than other formulations and was found to be 97.99±0.46 % drug release. Further, the stability study of the bilayer tablet was checked as per ICH guidelines and the results were complies to the IP standards. From the drug release study it is possible to reduce the frequency of dose.

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