Modern Approaches to Quality Assurance of Drug Formulation


Authors : Satyam Singh; Dr Swarup J. Chatterjee; Vishwanath Dubey

Volume/Issue : Volume 9 - 2024, Issue 11 - November


Google Scholar : https://tinyurl.com/2xyj6k84

Scribd : https://tinyurl.com/bde2cuwd

DOI : https://doi.org/10.38124/ijisrt/IJISRT24NOV945

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.


Abstract : Development of the pharmaceutical science have gone through amazing change over the past two decades, and modern technologies continue to transform QA process in drug formulation. considering the importance of ensuring the quality, safety, and efficacy of pharmaceutical products, it is now essential that the evolution of QA methodologies and techniques, especially these accelerate through automation analytics and regulatory frameworks, become important to this end. This review highlight the convince in QA of drug formulation, with more focus on latest trends such as "quality by design", process analytical technology and advance analytical techniques like spectroscopy, chemometrics, and artificial intelligence.

Keywords : Safety Standards, Quality Test, Continuous Improvement, Minimize Risk, Design Planning.

References :

  1. Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. New York (NY): Simon and Schuster; 1992.
  2. Woodcock J. The concept of pharmaceutical quality. Am Pharm Rev. 2004;7(6):10–15.
  3. Awotwe-Otoo D, Agarabi C, Wu GK, et al. Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody. Int J Pharm. 2012;438(1):167–175.
  4. Charoo NA, Shamsher AA, Zidan AS, et al. Quality by design approach for formulation development: A case study of dispersible tablets. Int J Pharm. 2012;423(2):167–178.
  5. Park S-J, Choo G-H, Hwang S-J, et al. Quality by design: screening of critical variables and formulation optimization of Eudragit E nanoparticles containing dutasteride. Arch Pharm Res. 2013;36(5):593–601.
  6. Verma S, Lan Y, Gokhale R, et al. Quality by design approach to understand the process of nano suspension preparation. Int J Pharm. 2009;377(1):185–198.
  7. Group IEW, editor ICH Harmonized tripartite guideline. Pharmaceutical development Q8 (R2). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2009.
  8. Li Z, Cho BR, Melloy BJ. Quality by design studies on multi-response pharmaceutical formulation modeling and optimization. J Pharm Innov. 2013;8(1):28–44.
  9. Elder D, Teasdale A. ICH Q9 quality risk management. In: Teasdale A, Elder D, Nims RM, editors. ICH quality guidelines: an implementation guide. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2017. p. 579–610.
  10. Pogány J. ICH pharmaceutical quality system Q10. WHO Drug Information. 2008;22(3):177–181.
  11. Guideline ICH. Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Q11. London, United Kingdom: European medicines agency; 2011.
  12. Lowenborg M. Quality-by-design: the good, the bad, the inevitable: drug development & delivery; 2014 [cited 2018 Jan 23] Available from: http://www.drug-dev.com/Main/Back- Issues/QUALITYBYDESIGN-QualitybyDesign-The-Good-The-Bad-T-768.aspx (open in a new window)
  13. Sangshetti JN, Deshpande M, Zaheer Z, et al. Quality by design approach: regulatory need. Arab J Chem. 2014;10(Suppl. 2):S3412–S3425. (Open in a new window)Google Scholar
  14. Plackett RL, Burman JP. The design of optimum multifactorial experiments. Biometrika.1946;33(4):305–325. (Open in a new window) Web of Science ®(Open in a new window)Google Scholar
  15. Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2017;12(1):1–8 (Open in a new window)PubMed (Open in a new window)Web of Science ®
  16. Box GEP, Wilson KB. On the experimental attainment of optimum conditions. In: Kotz S, Johnson NL, editors. Breakthroughs in statistics: methodology and distribution. New York, NY: Springer New York; 1992. p. 270–310. (Open in a new window)Google Scholar
  17. Collins A. Toward a design science of education. New directions in educational technology. NATO ASI series. Vol. 96. Berlin, Heidelberg: Springer Berlin Heidelberg; 1992. p. 15–22. (Open in a new window)Google Scholar
  18. Yang Y. Multiple criteria third-order response surface design and comparison. Florida: Florida State University; 2008. (Open in a new window)Google Scholar
  19. Box-Behnken  designs: NIST/SEMATECH;  2003 [cited 2018   Jan   23].   Available from: http://www.itl.nist.gov/div898/handbook/pri/section3/pri3362.htm(open in a new window) (Open in a new window)Google Scholar
  20. Box GEP, Hunter WG, Hunter JS. Statistics for experimenters: an introduction to design, data analysis, and model building. Illustrated ed. Vol. 154. US: Wiley (Wiley Series in Probability and Statistics); 1978. (Open in a new window)Google Scholar
  21. Araujo PW, Brereton RG. Experimental design II. Optimization. TrAC Trends Anal Chem. 1996;15(2):63–70. (Open in a new window)Web of Science ®(Open in a new window)Google Scholar
  22. Doornbos DA, De Haan P. Optimization techniques in formulation and processing. In: Swarbrick J, Jc B, editors. Encyclopedia of pharmaceutical technology. Vol. 20. Suppl. 3. New York (NY): Marcel Dekker, Inc.; 2001. p. 77–160. (Open in a new window)Google Scholar
  23. Pinto J, Podczeck F, Newton J. Investigations of tablets prepared from pellets produced by extrusion and spheronisation. II. Modelling the properties of the tablets produced using regression analysis. Int J Pharm. 1997;152(1):7–16. (Open in a new window)Google Scholar
  24. Podczeck F. The development and optimization of tablet formulations using mathematical methods. In: Alderborn G, Nyström C, editors. Pharmaceutical powder compaction technology. New York (NY): Informa HealthCare; 1996. p. 561–593. (Open in a new window)Google Scholar
  25. Chatchawalsaisin J, Podczeck F, Newton JM. The influence of chitosan and sodium alginate and formulation variables on the formation and drug release from pellets prepared by extrusion/spheronisation. Int J Pharm. 2004;275(1):41–60. (Open in a new window)PubMed(Open in a new window)Google Scholar
  26. Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical experimental design. New York (NY): CRC Press; 1998. (Open in a new window)Google Scholar
  27. Scheffé H. Experiments with mixtures. J Roy Stat Soc Series B (Methodol). 1958;2(2):344–360. (Open in a new window)Google Scholar
  28. Taguchi G, Ap O. Introduction to quality engineering: designing quality into products and processes. Unipub/Quality Resources; 1986. (Open in a new window)Google Scholar
  29. Lewis G. Non classical experimental designs in pharmaceutical formulation. Drug Dev Ind Pharm. 1991;17(12):1551–1570. (Open in a new window)Web of Science ®(Open in a new window)Google Scholar
  30. Wehrlé P, Palmieri G, The Taguchi’s SA. performance statistic to optimize theophylline beads production in a high-speed granulator. Drug Dev Ind Pharm. 1994;20(18):2823–2843. (Open in a new window)Web of Science ®(Open in a new window)Google Scholar
  31. Chariot M, Lewis G, Mathieu D, et al. Experimental design for pharmaceutical process characterisation and optimisation using an exchange algorithm. Drug Dev Ind Pharm. 1988;14(15– 17):2535–2556.

Development of the pharmaceutical science have gone through amazing change over the past two decades, and modern technologies continue to transform QA process in drug formulation. considering the importance of ensuring the quality, safety, and efficacy of pharmaceutical products, it is now essential that the evolution of QA methodologies and techniques, especially these accelerate through automation analytics and regulatory frameworks, become important to this end. This review highlight the convince in QA of drug formulation, with more focus on latest trends such as "quality by design", process analytical technology and advance analytical techniques like spectroscopy, chemometrics, and artificial intelligence.

Keywords : Safety Standards, Quality Test, Continuous Improvement, Minimize Risk, Design Planning.

Never miss an update from Papermashup

Get notified about the latest tutorials and downloads.

Subscribe by Email

Get alerts directly into your inbox after each post and stay updated.
Subscribe
OR

Subscribe by RSS

Add our RSS to your feedreader to get regular updates from us.
Subscribe