Abstract

L-Arginine is a semi-essential amino acid involved in numerous areas of human physiology, including production of nitric oxide (NO) a key messenger molecule. The purpose of the present work was to develop an optimized bilayer tablet for cardiac patient using L-Arginine as a drug candidate by optimization technique. In preliminary study, L-Arginine bilayer tablets were prepared by wet compression method. Preliminary study for immediate release and sustain release was done using different excipients like HPMC K15M, HPMC K100M, ethyl cellulose, Polyvinyl pyrrolidone, light magnesium oxide, Microcrystalline cellulose, sodium starch glycolate. Among them HPMC K100M, light magnesium oxide, SSG showed influence on drug release. A Box Behnken experimental design was employed in formulating bilayer tablets. HPMCK100M (X₁), Light Magnesium Oxide (X₂) and SSG (X₃) were selected as independent variables. Two dependent variables % CDR at 2 hrs (Y₁) and at 8 hrs (Y₂) were considered. The main effect and interaction terms were quantitatively evaluated using mathematical model. Bilayer tablets were evaluated for thickness, hardness, friability, drug content and in vitro dissolution studies. The drug release of L-Arginine obeyed the Korsmeyer-Peppas kinetic model which depicted fickian diffusion. Stability study was carried out at 25ºC / 60 %RH and 40^oC/ 75 %RH for 1 month and checked for the drug content and % CDR at 2 hrs and 8 hrs. Result of stability study indicated that optimized batch gives satisfactory result.

Keywords

Bilayer tablet, L-Arginine, SSG, Poly vinyl pyrrolidone, HPMC K100M, Light Magnesium Oxide

Cite This Article

Tripathi, A.R., Patel, K.N., Patel, P.A., Nayak, B.S., Shah, V. (2015). Formulation and Evaluation of Bilayer Tablets Containing L-Arginine, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 1-18.