Critical Material Attributes in Wet Granulation

Quality by design (QbD) is a scientific and risk-based approach applicable throughout the product development process. The QbD principles are outlined in the ICH guidelines (Q8, Q9, and Q10) and are aimed at establishing a systematic methodology for releasing quality pharmaceutical products into the market. Application of the QbD paradigm in wet granulation has led to an increased fundamental and mechanistic understanding of the process.

Specifications of raw materials and active substances, process control parameters, and in-process and drug product testing all become the components of the quality control strategy. Identification of these components prior to product development and establishing their operating space can lead to the design of a QbD-based drug product. This chapter focuses on one such essential component of the QbD concept, the critical material attributes (CMAs) relevant in the development of wet granulation-based products. Insights into various material properties have been provided, with a view to facilitate better understanding of their implications on the resultant granule characteristics.

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Article Information: Arvind K. Bansal, Garima Balwani, Sneha Sheokand; Sciencedirect



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