Formulation and Evaluation of Clarithromycin Floating Tablet

Saravanan, S (2013) Formulation and Evaluation of Clarithromycin Floating Tablet. Masters thesis, J.K.K. Nattraja College of Pharmacy, Komarapalayam.


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AIM :H.pylori is currently the single most common cause of peptic ulcer worldwide, accounting for 80% gastric ulcer and up to 95% of duodenal ulcers. Antimicrobial therapy is most acceptable choice of treatment for patients with active gastric or duodenal ulcers who are infected with H.pylori. Although H.pylori is sensitive to antimicrobial agents in-vitro, successful treatment of infection is challenging due to its unique. Characteristics, i.e., the bacterium tends to inhabit the gastric mucous gel and hence access for antimicrobial drug to the site of infection is restricted, both from the lumen of the stomach and from the gastric blood supply. Therefore for effective treatment, the therapeutic agents have to penetrate the gastric mucus layer to disrupt the mechanism of colonization, within the stomach environment. One way to improve the efficacy of eradicating H.pylori infection is to deliver the antibiotic locally to the stomach. This goal can be achieved by the development of hydrodynamically balanced system or floating drug delivery system which increases the gastric residence time, decreases the diffusional distance and allow more of the antibiotic to penetrate through the gastric mucus layer and act locally at the infectious site. Clarithromycin is one of the first line antibiotic in the treatment of H.pylori infection along with Amoxycillin and Omeprazole. The present study outlines a systematic approach for design and development of hydrodynamically balanced tablets of clarithromycin to enhance the bioavailability and therapeutic efficacy of the drug.OBJECTIVE OF THE STUDY:Design and development of the Hydrodynamically balanced tablets of Clarithromycin. • To study the effect of different polymers on the drug release. • Evaluation of the prepared formulation for physicochemical properties and drug release profile. • Analyse the drug release data for kinetic equations.SUMMARY AND CONCLUSION:In the present study Gastroretentive delivery systems of Clarithromycin were successfully developed in the form of Hydrodynamically Balanced Tablets to improve the local action and ultimately its bioavailability. The tablets were formulated using different grades of polymers (HPMC K4M, HPMC K15M and Chitosan) and effervescing agent (NaHCO3). IR spectra studies revealed that the drug and the polymers used were compatible. The evaluation parameters like hardness, friability and content uniformity were within the limits for various batches formulated. Buoyancy lag time, Total floating time, tablet density, Swelling studies showed satisfactory results for batch F1, F2, F3, F5, F6 and F8. The formulation F3 was evaluated for effect of hardness on floating lag time, and the results showed that the floating lag time increased as hardness increased due to reduction in porosity. In-vitro dissolution of batch F3 containing HPMC K15M showed good drug release rate in comparison to remaining batches containing chitosan, HPMC K4M, HPMC K10M which were not able to sustain their release up to 10 hrs. Formulations subjected to curve fitting analysis showed to best fit Korsemeyer – Peppas equation and followed non-Fickinian diffusion mechanism. Comparison study with marketed product Clarithro ER showed that the optimized formulation F3 has better control over release rate in comparison with the marketed product.Hence it was concluded that formulation F3 containing HPMC K15M showed better controlled drug release rate in comparison to other polymers and showed that the release decreases as the viscosity of the polymer increases. From the findings obtained, it can be concluded that:-

Item Type: Thesis (Masters)
Uncontrolled Keywords: Clarithromycin Floating Tablet
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 02 Feb 2018 11:55
Last Modified: 13 Feb 2018 06:00

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