Formulation-Development and In-Vitro-In Vivo Evaluation of Gastroretentive Floating Tablet Incorporating Clarithromycin

Abstract

The objective of the work is to summarize the applicability, manufacturing possibilities, excipients and the types of floating drug delivery systems and to optimize a floating, mucoadhesive system using Clarithromycin as the drug aiming at the eradication of Helicobacter pylori having desired floating and drug release properties based on preliminary excipient examination. Direct compressed (DC) tablet was chosen as dosage form being a cost-effective technology for pharmaceutical industry requiring fewer procedures. Before the implementation of the pharmaceutical technological aims, analysis of critical factors influencing the manufacture was carried out. Reproducible manufacturing processes are required to achieve suitability and tablets uniformity to achieve the uniform properties of tablets, which could influence experimental parameters. Ishikawa diagram evaluation was created, which is a commonly used graphical method to identify factors resulting in an overall effect on product design and quality imperfection. The aim was to reveal affecting factors on uniformity of DC tablets in order to standardize all possible conditions and adjustments. Critical factors are indicated separately in particular method sections.

Keywords: H. pylori, Clarithromycin, Floating Tablets, In Vitro Evaluation, In Vivo Evaluation.