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Design, development and evaluation of clopidogrel bisulfate floating tablets
K Rama Koteswara Rao1, K Rajya Lakshmi1
1Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla, Andhra Pradesh, India.
International Journal of Pharmaceutical Investigation
|March 29, 2014
Summary
This study developed clopidogrel bisulphate floating tablets using xanthan gum and HPMC polymers. Formulation F2 with 25% xanthan gum showed optimal floating time and drug release, improving bioavailability and reducing side effects.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Clopidogrel bisulphate has limited bioavailability and potential gastrointestinal side effects.
- Floating drug delivery systems offer a promising approach to enhance drug absorption and minimize adverse effects.
Purpose of the Study:
- To formulate and characterize a floating drug delivery system for clopidogrel bisulphate.
- To improve clopidogrel bioavailability and reduce side effects like gastric bleeding.
Main Methods:
- Tablets were prepared using direct compression with xanthan gum, HPMC K15M, and HPMC K4M polymers.
- Sodium bicarbonate and microcrystalline cellulose were used as gas-generating agent and diluent.
- In-vitro floating behavior, drug release, and kinetic analysis were performed in 0.1 N HCl.
Main Results:
- Drug release followed first-order and Higuchi kinetics, with non-Fickian diffusion as the dominant mechanism.
- Polymer type and concentration significantly affected clopidogrel release rate (P < 0.05).
- Increased polymer concentration led to a retarded drug release.
Conclusions:
- Formulation F2, utilizing 25% xanthan gum, demonstrated optimal in-vitro floating time and drug dissolution.
- This optimized formulation is suitable for enhancing clopidogrel bisulphate bioavailability.
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