• P-ISSN 0973-7200 E-ISSN 2454-8405
  • Follow us

Journal of Pharmaceutical Research

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
  • VIEWS 136
  • PDF 35

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

  3. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. The AAPS journal. 2014;16:771–783. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070262/pdf/12248_2014_Article_9598.pdf
  5. Sitre D, Kamble R. Articulation of Quality by Design Elements for Product Development and its Unique Applications. Journal of Drug Delivery and Therapeutics. 2020;10(3):253–261. Available from: https://jddtonline.info/index.php/jddt/article/view/4080/3130
  6. Bhise K, Kashaw SK, Sau S, Iyer AK. Mini review: Nanostructured lipid carriers employing polyphenols as promising anticancer agents: Quality by design (QbD) approach. International Journal of Pharmaceutics. 2017;526:506–515.
  7. Simoes A, Veiga F, Figueiras A, Vitorino C. A practical framework for implementing Quality by Design to the development of topical drug products: Nanosystem-based dosage forms. International journal of pharmaceutics. 2018;548(1):385–399. Available from: https://pubmed.ncbi.nlm.nih.gov/29953928/
  9. Gushiken AC, Saharia KK, Baddley JW. Cryptococcosis. Cryptococcosis. Infectious Disease Clinics of North America. 2021;35(2):493–514. Available from: https://www.sciencedirect.com/science/article/abs/pii/S0891552021000222?via%3Dihub
  10. Gershanik T, Benita S. Self-dispersing lipid formulations for improving oral absorption of lipophilic drugs. European Journal of Pharmaceutics and Biopharmaceutics. 2000;50(1):179–188. Available from: https://pubmed.ncbi.nlm.nih.gov/10840200/
  11. Gursoy RN, Benita S. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomedicine & pharmacotherapy. 2004;58(3):173–182. Available from: https://pubmed.ncbi.nlm.nih.gov/15082340/

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


More articles

DON'T MISS OUT!

Subscribe now for latest articles and news.