Sudeendra R Bhat , H G Shivakumar
Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore-570 015, Karnataka, India;For correspondence:- Sudeendra Bhat Email: sudeendrabhat@hotmail.com Tel:+918212548353
Received: 4 January 2010 Accepted: 26 June 2010 Published: 25 August 2010
Citation: Bhat SR, Shivakumar HG. Bioadhesive Controlled Release Clotrimazole Vaginal Tablets. Trop J Pharm Res 2010; 9(4):339-346 doi: 10.4314/tjpr.v9i4.3
© 2010 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
Methods: The tablets were prepared by direct compression using bioadhesive polymer mixtures: hydroxypropyl methylcellulose/sodium carboxymethylcellulose (HPMC/NaCMC) and HPMC/Guar gum (GG) in different ratios. Differential scanning calorimetry (DSC) and Fourier transform infrared (FT-IR) spectroscopic evaluations were carried out to assess compatibility between the drug and the excipients. The tablets were subjected to various pre- and post-compression evaluations, including in vitro drug release, in vitro bioadhesive strength, swelling and stability studies.
Results: The results show that all the formulations satisfied Indian Pharmacopoeial specifications for tablet parameters. DSC and FT-IR data indicate there was no interaction between the drug and the excipients. Drug dissolution rate at pH 6.0 followed the rank order: HPMC)/NaCMC > HPMC/GG. There was increase in swelling index with time at 37 0C. The combination of HPMC with NaCMC showed greater mucoadhesive strength and superior controlled drug release to the formulations prepared with GG polymer mixture. Furthermore, the release properties of the former in pH 6.0 buffer, as well as release mechanism (n values), were negligibly affected by ageing.
Conclusion: This study indicates the possible use of suitable mixtures of natural and semi-synthetic cellulosic polymers for the preparation of clotrimazole mucoadhesive tablets for application as a vaginal controlled delivery system.
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