Kabita Banik¹*, S Namratha² and Twila Pushpa³

¹Assistant Professor, Department of Pharmaceutics, Bharat Institute of Technology, Mangalpally, Hyderabad, Telangana, India
²Assistant Professor, Department of Pharmaceutical Analysis, Bharat Institute of Technology, Mangalpally, Hyderabad, Telangana, India
³Assistant Professor, Department of Pharmacy Practice, Bharat Institute of Technology, Mangalpally, Hyderabad, Telangana, India

*Corresponding Author: Kabita Banik, Assistant Professor, Department of Pharmaceutics, Bharat Institute of Technology, Mangalpally, Hyderabad, Telangana, India.

Received: May 30, 2022; Published: July 03, 2022

Abstract

The purpose of the research was to develop and evaluate Clarithromycin loaded, Cellulose acetate phthalate (CAP) enteric coated, controlled release microcapsules where talc is used as an anti aggrading agent. Clarithromycin degrades rapidly at normal gastric pH (1.0-2.0) and remains stable at intestinal pH at 7.4-10 and shows rapid first-pass hepatic metabolism. In order to improve the bioavailability and reduce the gastric degradation, enteric coating microencapsulation was prepared. Clarithromycin microcapsules were formulated by solvent evaporation technique while using 2² factorial designs. A 2² full factorial designs was used to derive a statistical equation, ANOVA analysis, contour plots, and 3D response surface plots. Different polymer and anti aggregating agent ratios of CAP and talc were used to formulate five formulations (F1 to F5) of microcapsules. The relationship between dependent variables (Percentage drug release, drug entrapment efficiency, angle of repose) and independent variables (CAP and Talc) has been established by regression analysis and ANOVA.

The optimized formulations F2 exhibited high drug entrapment efficiency of 94.90 ± 0.02%, Angle of repose of % drug release of 71.51 ± 0.04% at 10 hrs. Microcapsules showed drug release by diffusion in the hydrated matrix and polymer relaxation as a controlled release mechanism.

Keywords: Clarithromycin; Enteric Coated Microencapsulation; Solvent Evaporation Technique; Cellulose Acetate Phthalate (CAP); Factorial Design

References

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Citation

Citation: Kabita Banik., et al. “Formulation and Evaluation of Clarithromycin Enteric Coated Microcapsules Using 2² - Full Factorial Designs". Acta Scientific Pharmaceutical Sciences 6.8 (2022): 42-53.

Copyright

Copyright: © 2022 Kabita Banik., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.