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Formulation and Evaluation of Gastroretentive Dosage Forms of Clarithromycin

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Abstract

The purpose of this research was to develop the hydrodynamically balanced delivery system of Clarithromycin (CLA) which, after oral administration should have the ability to prolong gastric residence time with the desired in vitro release profile for the localized action in the stomach, in the treatment of Helicobacter pylori (H.pylori) mediated peptic ulcer. By applying wet granulation technique floating tablets of Clarithromycin were prepared. The proportion of sodium bicarbonate was varied to get the least possible lag time, also the polymer part varied to get the desired release. In vivo radiographic studies were performed with Barium sulphate loaded formulation to justify the increased gastric residence time of the dosage form in the stomach, based on the floating principle. The formulation developed using 66.2% Clarithromycin, 12% HPMC K4M polymer, 8% sodium bicarbonate gave floating lag time less than 3 min with a floating time of 12 h, and an in vitro release profile very near to the desired release. X-ray studies showed the enhanced gastric residence time of the tablet to 220 ± 30 min. The mechanism of release of Clarithromycin from the floating tablets is anomalous diffusion transport and follows zero order kinetics. In vivo radiographic studies suggest that the tablet has increased gastric residence time for the effective localized action of the antibiotic (Clarithromycin) in the treatment of H.pylori mediated peptic ulcer.

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Acknowledgements

The authors are expressing their sincere thanks to Cadila Pharmaceuticals, Ahmedabad Ind, for providing drug sample, Danmed Pharmaceuticals, Hyd, Ind, for providing gift samples of excipients. The authors also acknowledge St. Peter’s Institute of Pharmaceutical Sciences for providing facilities to carryout the research work and All Indian Council for Technical Education for providing financial assistance.

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Authors and Affiliations

  1. Pharmaceutics, St. Peter’s Institute of Pharmaceutical Sciences, Warangal, Andhra Pradesh, India

    Muralidhar Nama, Chandra Sekhar Rao Gonugunta & Prabhakar Reddy Veerareddy

  2. St. Peter’s Institute of Pharmaceutical Sciences, Vidya Nagar, Hanmakonda, A.P., 506001, India

    Prabhakar Reddy Veerareddy

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  1. Muralidhar Nama
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  2. Chandra Sekhar Rao Gonugunta
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  3. Prabhakar Reddy Veerareddy
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Correspondence to Prabhakar Reddy Veerareddy.

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Nama, M., Gonugunta, C.S.R. & Reddy Veerareddy, P. Formulation and Evaluation of Gastroretentive Dosage Forms of Clarithromycin. AAPS PharmSciTech 9, 231–237 (2008). https://doi.org/10.1208/s12249-008-9038-8

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  • DOI: https://doi.org/10.1208/s12249-008-9038-8

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