Design and Development of Oxyclozanide Chewable Tablet Formulation Employing Quality by Design Approach

Abstract:

Background: The focus of this research was to identify undiscovered knowledge associated with the production of oxyclozanide tablets utilizing Quality by Design (QbD) in order to develop an ideal formulation that would guarantee constant product quality. The modern approach to formulation design and optimization essentially entails QbD which is a systemic method of pharmaceutical development and comprises of the design and development of formulations as well as manufacturing processes to meet the target product quality. Materials and Methods: Pre-formulation studies on excipient flow properties, compactibility and tabletability profiles, identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) were carried out. An experimental design was adopted to investigate the effect of formulation and process variables (compression force, super-disintegrant type and concentration) on the CQAs using Modde Pro 12.1. The obtained results were used to generate a Design Space (DS) based on the study data. Results: Preformulation studies carried out on the core excipients used, gave an understanding to their tabletability and compactibility. Process parameters such a compaction force and formulation variables such as super-disintegrant concentration were studied within the framework of Quality by Design (QbD) and the new optimized formulation derived was tested and confirmed to be within the design space generated. Conclusion: At the end of the study, the aim was achieved; which was to implement pre-formulation studies and QbD to design a formulation containing Oxyclozanide (API) with a combination of excipients.

Keywords: Quality by Design (QbD), Oxyclozanide, Chewable tablet, Compactibility, Tabletability.