Sunday , 1 September 2024

Formulation and Evaluation of Sustained Release Mucoadhesive Bilayer Tablets of Nifedipine and Hydralazine HCl Using Statistical Optimization Technique

N. Janaki*, C. Mokshavathi, Dr. U. Mohan Kumar, Dr. S. Shameem, Dr. A. Sai Poojitha, S. Venkata Subbaiah
Department of Pharmaceutics, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh

A B S T R A C T
This study aimed to enhance the bioavailability and sustain the release of antihypertensive drugs nifedipine and hydralazine HCl, both of which suffer from poor oral bioavailability and short plasma half-lives, by formulating mucoadhesive buccal tablets using natural biodegradable polymers like xanthan gum and pectin. The formulations were evaluated for various physicochemical properties, including precompression characteristics, UV analysis, and compatibility studies, all of which met standard criteria. Comprehensive post-compression evaluations were performed, including assessments of surface pH, mucoadhesive strength, in vitro drug release, release kinetics, in vivo absorption, and stability. These studies yielded satisfactory results. FTIR spectra and DSC thermograms indicated no interaction between the polymers and the drugs. In vitro drug release studies demonstrated that the nifedipine tablet formulated with xanthan gum and carbopol (FNX6) achieved maximum sustained release over 10 hours. Similarly, the hydralazine HCl tablet (FHX8) exhibited prolonged drug release for 10 hours with high-concentration polymers. Drug release kinetics analysis revealed that the release data best fit the Higuchi model, indicating diffusion-controlled drug release through the buccal tablets. Short-term stability studies confirmed that there were no significant changes in physical appearance, swelling index, drug content, buccoadhesive strength, and in vitro drug release profile, affirming the stability of the formulations under the test conditions.

Keywords: nifedipine, hydralazine HCl, FTIR spectra, buccoadhesive, controlled drug release

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