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Journal of Pharmaceutical Research

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Development of a Novel Emulsified Oral Dosage form of an Antifungal Drug in a Quality by Design Framework and Verifying its Critical Quality Attributes
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v18.1.roopesh

Year: 2019, Volume: 18, Issue: 1, Pages: 20-26

Original Article

Development of a Novel Emulsified Oral Dosage form of an Antifungal Drug in a Quality by Design Framework and Verifying its Critical Quality Attributes

Roopesh S K1, Chandramouli R1,∗

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

Objectives: The aim of this study was to formulate a novel BCS class II antifungal formulation of itraconazole and optimise its critical quality attributes (CQAs) using a Quality by Design (QbD) approach. Methods: Material attributes and CQAs were identified using risk assessment according to the International Conference of Harmonization (ICHQ9) quality guidelines. The material attributes were found to be the ratios of surfactant (Tween 80) and co-surfactant (Transcutol). The CQA selected for optimization was dissolution. A screening design was performed on the surfactant and co-surfactant to fix the ratio of Smix, resulting in four optimized ratios: 1:1, 1:3, 5:3, and 5:1. Pseudo ternary phase diagrams were constructed, and ranges for excipients were fixed. Based on the results of the screened ratios, a Mixture Design – Design of Experiment (DoE) was used for optimization. Findings: Optimized runs of ten runs for dissolution were achieved by the application of the mixture design, with formulation F2 showing a maximum release of 93.35%. Novelty: Quality by Design (QbD) can be utilized to optimize the CQAs of a novel BCS class II antifungal formulation, itraconazole.

Keywords: QbD, Screening design, Mixture design, Extreme vertices, SEDDS, Itraconazole

References

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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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