Abstract

FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF ORAL SUSTAINED RELEASE FLOATING TABLETS OF CHLOROGENIC ACID

Aditi Mool*, Dr. Archana Moon, Dr. Veena Belgamwar, Dr. Sheelpriya Walde and Dr. Sunil Gupta

ABSTRACT

The purpose of the study was to develop sustained release floating tablet of chlorogenic acid (CGA) and optimize its drug release for enhanced oral bioavailability. A relatively new approach, 32 full factorial design, was used to formulate floating sustained release tablets of CGA and to systematically optimize its drug release using varying levels of sodium bicarbonate and hydroxypropyl methylcellulose (HPMC) K 15 M polymer. Sodium bicarbonate was used as gas generating agent. After setting the levels by preliminary trials, nine tablet formulations (F1 - F9) were prepared by wet granulation method using Design Expert Software® - suggested combinations. The concentrations of HPMC K15M (X1) and sodium bicarbonate (X2) were chosen as control variables. Conversely, the response variables selected were percentage (%) of drug released within 12 hours (Y1) and time taken by the tablet to float (Y2). Fourier transform infrared (FTIR) spectroscopy was used to assess compatibility between the drug and the excipients. The response surface and 3D plots drawn demonstrated the suitability of the hydrophilic matrix forming agents for formulating sustained release floating tablets of CGA. FTIR and DSC spectra showed no noticeable incompatibility between drug and polymers in both physical mixtures and in formulations. Floating lag time remained was < 3.00 min with floating duration of > 12 h. Considerable agreement was observed between predicted and actual release parameters. Formulation batch (F9) showed satisfactory release profile and floating lag time and thus was selected as the optimized formulation.

Keywords: Chrologenic acid (CGA), sustained release floating tablets, hydroxy propyl methyl cellulose K 15 M (HPMC K 15 M), Sodium bicarbonate, 32 full Factorial design.