Formulation and process optimisation of ethionamide 250 MGtablets using quality by design principles

The traditional approach of Quality by Testing (QbT) limits the assurance of product quality to in-process and post-production testing. To overcome these limitations, a more proactive and systematic means to product development and optimisation is required. Quality by Design (QbD) is an example of s...

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Bibliographic Details
Main Author: Isaacs, Nasreen
Format: Others
Language:English
Published: Nelson Mandela Metropolitan University 2015
Subjects:
Online Access:http://hdl.handle.net/10948/3979
Description
Summary:The traditional approach of Quality by Testing (QbT) limits the assurance of product quality to in-process and post-production testing. To overcome these limitations, a more proactive and systematic means to product development and optimisation is required. Quality by Design (QbD) is an example of such an approach which focuses on understanding the product and its manufacturing process and emphasises that quality should be built into the product and not merely tested. The study aims to optimise ethionamide tablets, an immediate release oral solid dosage form using QbD.