QUALITY BY DESIGN APPROACH FOR AN ORALLY DISINTEGRATING TABLET ANALYTICAL METHOD VALIDATION
Abstract
Quality by Design (QbD) is well established in the pharmaceutical industry for pharmaceutical development and manufacturing processes. The knowledge obtained during development may support the establishment of a design space and determines suitable process controls. This same QbD principle has been applied to the development of analytical methods and is termed “Analytical Quality by Design” (AQbD). Analogous to process QbD, the outcome of AQbD is well understood, fit for purpose, and robust method that consistently delivers the intended performance throughout its life cycle. The present work is aimed to develop an AQbD approach to analytical method development and validation based of Tadalafil and its impurities by the NP-HPLC method. The other objective of this work is to establish an in-depth understanding of the method and build in the quality during the method development to ensure optimum method performance over the lifetime of the product.
Keywords:
Analytical Quality by Design (AQbD), Quality by Design (QbD), Robustness, Analytical Method ValidationDOI
https://doi.org/10.25004/IJPSDR.2018.100103References
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14. Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Borman P, Hansen G, Smith K and Larew J, Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharm. Tech. 2010; 34: 52-59.
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17. Lateef SS, Vinayak AK. Agilent Technologies, Inc. Bangalore, India Quality-by-Design Approach to Stability Indicating Method Development for Linagliptin Drug Product, 2014.
18. Cecchini D, Rathore AS, Branning R. Quality: Design Space for Biotech Products. BioPharm Int. April 2007.
19. Mitchell M. Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum. BioPharm International. December 2013.
20. Fanun M. The Role of Colloidal Systems in Environmental Protection, Elsevier , 2014
21. Kale SA, Bajaj VH. Application of central composite experimental design to optimise sustained release tablet formulations of muscle relaxant baclofen. International Journal of Applied Research 2016; 2(6): 1037-1043.
22. Gain, Greater Confidence Agilent Solutions for Quality-By-Design Implementation In Pharmaceutical Development, Primer, Agilent, USA February 2014.
23. Galen WE, Analytical Instrumentation Handbook; 2nd Edn; Marcel Dekker Inc., New York, 2004; 1123-1125, 1183.
24. Snyder LR, Kirkland JJ, Glajch LJ. Practical HPLC Method Development; 2nd Edn; John Wiley & Sons Inc., New York, 1997.
25. Sirajuddin SS, Rajkotwala AS, Dedania RR, Dedania ZR, Vijendraswamy SM. Stability indicating HPTLC method development and validation of mesalamine. World Journal of Pharmacy and Pharmaceutical Sciences 2016; 5(5):1289-1300.
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27. FDA/CDER Small Business Chronicles, New Drug Quality, September 18th 2012.
2. Hirani JJ, Rathod DA, Vadalia KR. Orally Disintegrating Tablets. Tropical Journal of Pharmaceutical Research. April 2009; 8 (2): 161-172.
3. Snyder LR, Kirkland JJ, Glajch LJ. Practical HPLC Method Development, John Wiley and Sons Inc., New York, 1988; 3, 2-21.
4. Validation of Chromatographic Methods, Reviewer Guidance, Center for Drug Evaluation and Research (CDER), November 1994; 17
5. Juran JM: “Juran on Quality by Design”, Google Books.
6. US Food and Drug Administration, Pharmaceutical cGMPs for the 21th Century – A risk Based Approach, 2004.
7. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q8 Pharmaceutical development, 2006.
8. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q2(R1) Validation of Analytical procedures: Text and Methodology, 2005.
9. Department of Health and Human Services, 1. U.S. Food and Drug Administration, Pharmaceutical cGMPs for the 21st century – A risk-based approach, Final report, September, 2004.
10. Bhatt DA, Rane SI. QbD approach to analytical RPHPLC method development and its validation. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(1): 179-187.
11. The International Conference on Harmonisation (ICH) Q8(R2): Pharmaceutical Development (August 2009).
12. The International Conference on Harmonisation (ICH) Q11: Development and Manufacture of Drug Substance.
13. Borman P, Nethercote P, Chatfield M, Thompson D, Truman K. The Application of Quality by Design to Analytical Methods. Pharm. Tech. 2007; 31: 142-152.
14. Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Borman P, Hansen G, Smith K and Larew J, Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharm. Tech. 2010; 34: 52-59.
15. Thomas P. QbD for Analytical Methods: FDA and Industry Perspectives, Pharma QbD, Oct 2011.
16. Chatterjee S, Ph.D. CMC Lead for QbD ONDQA/CDER/FDA, QbD Considerations for Analytical Methods – FDA, Perspective, IFPAC Annual Meeting Baltimore, January 25, 2013.
17. Lateef SS, Vinayak AK. Agilent Technologies, Inc. Bangalore, India Quality-by-Design Approach to Stability Indicating Method Development for Linagliptin Drug Product, 2014.
18. Cecchini D, Rathore AS, Branning R. Quality: Design Space for Biotech Products. BioPharm Int. April 2007.
19. Mitchell M. Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum. BioPharm International. December 2013.
20. Fanun M. The Role of Colloidal Systems in Environmental Protection, Elsevier , 2014
21. Kale SA, Bajaj VH. Application of central composite experimental design to optimise sustained release tablet formulations of muscle relaxant baclofen. International Journal of Applied Research 2016; 2(6): 1037-1043.
22. Gain, Greater Confidence Agilent Solutions for Quality-By-Design Implementation In Pharmaceutical Development, Primer, Agilent, USA February 2014.
23. Galen WE, Analytical Instrumentation Handbook; 2nd Edn; Marcel Dekker Inc., New York, 2004; 1123-1125, 1183.
24. Snyder LR, Kirkland JJ, Glajch LJ. Practical HPLC Method Development; 2nd Edn; John Wiley & Sons Inc., New York, 1997.
25. Sirajuddin SS, Rajkotwala AS, Dedania RR, Dedania ZR, Vijendraswamy SM. Stability indicating HPTLC method development and validation of mesalamine. World Journal of Pharmacy and Pharmaceutical Sciences 2016; 5(5):1289-1300.
26. The European Pharmacopoeia (Ph. Eur. 9th Edition).
27. FDA/CDER Small Business Chronicles, New Drug Quality, September 18th 2012.
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01-01-2018
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“QUALITY BY DESIGN APPROACH FOR AN ORALLY DISINTEGRATING TABLET ANALYTICAL METHOD VALIDATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 10, no. 1, Jan. 2018, pp. 12-19, https://doi.org/10.25004/IJPSDR.2018.100103.
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How to Cite
“QUALITY BY DESIGN APPROACH FOR AN ORALLY DISINTEGRATING TABLET ANALYTICAL METHOD VALIDATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 10, no. 1, Jan. 2018, pp. 12-19, https://doi.org/10.25004/IJPSDR.2018.100103.
