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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

References

  1. Mathur M, Devi VK. Potential of novel drug delivery strategies for the treatment of hyperlipidemia. Journal of Drug Targeting. 2016;24(10):916–926. Available from: https://doi.org/10.3109/1061186X.2016.1172586
  2. Li C, Wang J, Wang Y, Gao H, Wei G, Huang Y, et al. Recent progress in drug delivery. Acta Pharmaceutica Sinica B. 2019;9(6):1145–1162. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900554/pdf/main.pdf
  4. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Advanced Drug Delivery Reviews. 2001;46(1-3):3–26. Available from: https://doi.org/10.1016/S0169-409X(00)00129-0
  5. Rogerson WP. Reputation and product quality. The Bell Journal of Economics and Management Science. 1983;14:508–516. Available from: https://www.jstor.org/stable/3003651
  6. Zhang L, Mao S. Application of quality by design in the current drug development. Asian Journal of Pharmaceutical Sciences. 2017;12:1–8. Available from: https://doi.org/10.1016/j.ajps.2016.07.006
  9. Alshaer W, Nsairat H, Lafi Z, Hourani OM, Al-Kadash A, Esawi E, et al. Quality by Design Approach in Liposomal Formulations: Robust Product Development. Molecules. MDPI. 2022;28:1–19. Available from: https://doi.org/10.3390/molecules28010010
  11. Salem HF, Kharshoum RM, Halawa AKA, Naguib DM. Preparation and optimization of tablets containing a self-nano emulsifying drug delivery system loaded with rosuvastatin. Journal of Liposome Research. 2017;28:149–160. Available from: https://www.tandfonline.com/doi/full/10.1080/08982104.2017.1295990
  12. Kulkarni NS, Ranpise NS, Mohan G. Development and Evaluation of Solid Self Nano- Emulsifying Formulation of Rosuvastatin Calcium for Improved Bioavailability. Tropical Journal of Pharmaceutical Research. 2015;14:575–582. Available from: https://www.ajol.info/index.php/tjpr/article/view/116592
  16. Shelke S, Shahi S, Jadhav K, Dhamecha D, Tiwari R, Patil H. Thermoreversible nano-ethosomal gel for the intranasal delivery of Eletriptan hydrobromide. Journal of Materials Science: Materials in Medicine. 2016;27:1–3. Available from: https://link.springer.com/article/10.1007/s10856-016-5713-6
  18. Prajapati K, Bhandari A. Spectroscopic method for estimation of atorvastatin calcium in tablet dosage form. Indo Global Journal of Pharmaceutical Sciences. 2011;1(4):294–303.
  21. Mathur M, Devi K, V. Potential of novel drug delivery strategies for the treatment of hyperlipidemia. Journal of drug targeting. 2016;24(10):916–926. Available from: https://www.tandfonline.com/doi/pdf/10.3109/1061186X.2016.1172586
  22. Shelke S, Shahi S, Jalalpure S, Dhamecha D, Shengule S. Formulation and evaluation of thermoreversible mucoadhesive in-situ gel for intranasal delivery of naratriptan hydrochloride. Journal of Drug Delivery Science and Technology. 2015;29:238–244. Available from: https://dx.doi.org/10.1016/j.jddst.2015.08.003
  23. Sinkula AA, Yalkowsky SH. Rationale for Design of Biologically Reversible Drug Derivatives: Prodrugs. Journal of Pharmaceutical Sciences. 1975;64(2):181–210. Available from: https://doi.org/10.1002/jps.2600640203

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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