Abstract

FORMULATION AND DEVELOPMENT OF ACECLOFENAC AND MISOPROSTOL MODIFIED RELEASE OF BILAYER TABLETS

P. Deepika*, L. Gopi, Dr. V. Kalvimoorthi, M. Eshvandhini and Dr. K. Kaveri

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Abstract

This study focused on developing a bilayer tablet of aceclofenac and misoprostol using a matrix system with swellable polymers for sustained drug release. The formulation included HPMC, Xanthan Gum, and Sodium Carboxy methyl cellulose to achieve a 24-hour controlled release profile. Various sustained release (SR) batches were prepared using the wet granulation technique. The formulations were evaluated for their physical and chemical characteristics, in vitro dissolution, and stability. Drug-excipient interactions were studied using FTIR. The physical characteristics of all formulations were satisfactory. The tablets met official monograph limits for assay, weight variation, hardness, and thickness. In vitro dissolution testing showed that SR formulation F12 achieved a 24-hour release profile, complying with USP standards, particularly with HPMC K100, when compared to the other 11 formulations. Stability studies conducted at room temperature and 40°C/75% RH over three months demonstrated that the tablets remained stable, with physical appearance, dissolution, and assay results within specified limits. The SR tablets of aceclofenac and misoprostol were stable and successfully formulated to reduce administration frequency and improve patient compliance.

Keywords: Aceclofenac, Misoprostol, Modified Release, Bilayer Tablet.