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Journal of Pharmaceutical Research

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Development and Validation of Critical Quality Attributes of a Novel Formulation of an Antihyperlipidemic Drug by Quality by Design Approach
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v18.1.deborose

Year: 2019, Volume: 18, Issue: 1, Pages: 13-19

Original Article

Development and Validation of Critical Quality Attributes of a Novel Formulation of an Antihyperlipidemic Drug by Quality by Design Approach

Deborose Soans1, R Chandramouli1,∗

1Department of Quality Assurance, Krupanidhi College of Pharmacy, Carmelaram, Varthur Hobli, Bengaluru, Karnataka, India

*Corresponding Author
Email: [email protected]

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

To formulate a novel Biopharmaceutics Classification System class II antihyperlipidemic drug and optimize its critical quality attributes using a quality-by-design approach. Atorvastatin was the drug of choice in this study. The material and critical quality attributes were identified by risk assessment, as per the International Conference of Harmonization Quality Guidelines. Material attributes were found to be the amounts of microcrystalline cellulose and croscarmellose sodium; the critical quality attribute selected for optimization was dissolution. A screening design with five experimental runs was performed for the amounts of croscarmellose sodium and microcrystalline cellulose in the ranges of 11–21 mg and 80–160 mg, respectively. The response surface methodology was used for optimization based on the results of the screening batches. A full factorial central composite design with 10 experimental runs was performed using microcrystalline cellulose and croscarmellose sodium in the range of 80–120 mg and 11–20 mg, respectively. Of these runs, batch R1 showed a drug release of 92.47% in 30 min with microcrystalline cellulose (120 mg) and croscarmellose sodium (16 mg). Quality by Design can be applied to optimize critical quality attributes and meet the desired Quality Target Product Profile.

Keywords: Quality by Design, Screening design, Full factorial design, Central composite design, Atorvastatin

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Copyright

© 2019 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

  • 22 September 2024

Year: 2019, Volume: 18, Issue: 1


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