24.Issue 02 february 22 - INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

Volume : 09, Issue : 02, February – 2022

Title:

24.STABILITY TESTING OF NEW PHARMACEUTICAL DRUG PRODUCTS

Authors :

Archana Gahtori, Taniya Mamgain*

Abstract :

The ability of a specific pharmaceutical substance or product in a specific closed system (container), to remain stable or among its specifications of physical, therapeutic, chemical, microbiological parameters right through its shelf life, it is known as the stability. The stability studies is a vital parameter in every field including the pharmaceutical sciences for the manufacturing of new pharmaceutical drugs as well as new pharmaceutical formulations. The assumption of the shelf-life is vital for the manufacturing of a pharmaceutical product of all the dosage forms and also the stability testing is performed to determine the instructions and conditions for the label and storage of a specific pharmaceutical dosage form.
For the manufacturing and acceptance of the pharmaceutical product i.e. the drug product or the API (Active Pharmaceutical Ingredient) i.e. the drug substance, stability testing are needed. For the acceptance and approval of pharmaceutical finished products, stability testing are necessary for confirming the products safety, quality and efficacy right through its shelf life.
This review paper represents the stability parameter which is used for the analysis of new finished product. The stability testing are required to be performed in a planned manner as per the ICH (International Conference on Harmonisation), WHO (World Health Organization) or other regulatory bodies. The ICH guideline for performing the new pharmaceutical finished product’s stability testing are shown in this review paper.
Keywords: Stability studies, pharmaceutical product, stability zones, ICH guideline, stability testing

Cite This Article:

Please cite this article in press Taniya Mamgain et al, Stability Testing Of New Pharmaceutical Drug Products., Indo Am. J. P. Sci, 2022; 09(2)

Number of Downloads : 10

References:

1. Markens U. (2009) Conducting Stability Studies: Recent Changes to Climate Zone IV, Life Science 13.
2. Madichie C. (2015) Designing a Smart Stability Protocol for the Global Market to Minimise Time and Cost. Informa Life Sciences’ Annual Stability Testing for Pharmaceuticals and Biologics: London, UK.
3. ICH Q5C (1996) Stability Testing of Biotechnological Products. Federal Register, 36466.
4. Committee for Proprietary Medicinal Products (2001) Note for Guidance on In-Use Stability Testing of Human Medicinal Products. The European Medinces Agency: London, UK.
5. ICH Q1A (R2) (2003) Stability Testing of New Drug Substances and Products. Federal Register, 65717–65718.
6. ICH Q1B (1997) Stability Testing: Photostability Testing of New Drug Substances and Products. Federal Register, 27115–27122.
7. ICH Q1C (1997) Stability Testing for New Dosage Forms. Federal Register, 25634–25635.
8. ICH Q1D (2003) Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Federal Register, 2339–2340.
9. ICH Q1E (2004) Evaluation of Stability Data. Federal Register, 32010–32011.
10. “Conducting stability studies – recent changes to climatic zone IV”, https://www.sgs.com/~/media/global/documents/technical%20documents/sgs%20stability%20studies-en-09.pdf
11. Choudhary ankur (2010) Climatic zones for stability studies, pharmaceutical guidelines, https://www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html
12. CFR 211.166. (2014) Stability Testing. Code of Federal Regulations. Food and Drug Administration: Rockville, MD.
13. Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. USP38–NF33. US Pharmacopeial Convention: Rockville, MD, 2014.
14. Cell and Gene Therapy Products. USP24–NF19. US Pharmacopeial Convention: Rockville, MD, 2014.
15. CPMP/QWP/609/96: (2007) Declaration of Storage Conditions. European Medicines Agency: London, UK.
16. CPMP/QWP/2934/99: (2001) In-Use Stability Testing. . European Medicines Agency: London, UK.
17. CPMP/QWP/159/96: (1998) Maximum Shelf Life for Sterile Products After First Opening or Following Reconstitution. Committe for Human Medicinal Products. European Medicines Agency: London, UK.
18. Nita AS. (2015) Outlining Key Differences in Regulatory Requirements and Expectations for Stability Studies in Key Emerging Markets. Informa Life Sciences’ Annual Stability Testing for Pharmaceuticals and Biologics: London, UK.
19. Personal correspondence with Alison Armstrong, (2015) PhD, senior director of development services at BioReliance.
20. G. Jimenez (2011) Brake B. ICH Q5C Stability Testing of Biotechnological/Biological Products. EMA Training for ASEAN, 30–31 May 2011; www.ich.org/fileadmin/Public_Web_Site/Training/ASEAN_Q5C_workshop_May_2011/SESSION_Ia_ICH_Q5C.pdf.
21. Wonnacott K. Cell Therapy Products. FDA Office of Cellular, Tissue, and Gene Therapy, Web Seminar Series; www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm241308.htm.
22. Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. US Food and Drug Administration: Rockville, MD.
23. Kling J. (2014) Highly Concentrated Protein Formulations: Finding Solutions for the Next Generation of Parenteral Biologics. BioProcess Int. 12(5).
24. Waddle K, Pan W. Stability Studies in Pharmaceutical Development; www.catalent.com.
25. Panchal JP (2015) Analyzing Subvisible Particles in Protein Drug Products: A Comparison of Dynamic Light Scattering (DLS) and Resonant Mass Measurement (RMM). Biopharmaceutical Development and Production Week, Huntington Beach, California.
26. Neergaard MS (2014) Stability of Monoclonal Antibodies at High-Concentration: Head-to-Head Comparison of the IgG1 and IgG4 Subclass. J. Pharm. Sci. 103(1): 115–127.
27. Bott RF., Oliveira WP. (2007) Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev. and Indus. Pharm. 33:393-401.
28. Carstensen JT., Rhodes CT. (1993) Clin. Res. Drug Reg. Affairs. 10:177-185
29. Carstensen JT. (2000) Drug Stability, Principles and Practices, Marcel Dekker, New York
30. Cha J., Gilmor T., Lane P., Ranweiler JS. (2001) Stability studies in Handbook of modern pharmaceutical analysis. Separation Science and Technology. Elsevier 459-505
31. Connors KA., Amidon GL., Kennon L. (1973) Chemical stability of pharmaceuticals-a handbook for pharmacists, 8-119.
32. CPMP. (2003) Guideline on stability testing: Stability testing of existing active substances and related finished products. CPMP/QWP/122/02.
33. Gaur A., Mariappan TT. Bhutani H., Singh S. (2005) A Possible Reason for the Generation of Out-of-Trend Stability Results: Variable Air Velocity at Different Locations Within the Stability Chamber. Pharm. Technol. 29:46-49.
34. Grimm W., Schepky G. (1980) Stabilitatsprufung in der Pharmazie, Theorie und Praxis, Editio Cantor Verlag, Aulendorf.
35. Grimm W. (1998) Extension of the international conference on harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones 3 and 4. Drug Dev. Ind. Pharm. 24:313-325
36. ICH Q1A (R2). (2003) Stability testing guidelines: Stability testing of new drug substances and products. ICH Steering Committee.
37. ICH Q1B. (1996) Guidance for Industry: Photostability testing of new drug substances and products. CDER, US FDA.
38. Kommanaboyina B., Rhodes CT. (1999) Trends in stability testing, with Emphasis on Stability During Distribution and Storage. Drug Dev. Ind. Pharm. 25:857-867.
39. Lachman L., DeLuca P. (1976) Kinetic principles and stability testing. The theory and practice of industrial pharmacy, 2nd ed. Philadelphia. Lea and Febiger 32-89.
40. Lionberger AR., Lee LS. Lee L., Raw A., Yu XL. (2008) Quality by design: Concepts for ANDAs. The AAPS Journal. 10:2.
41. Matthews RB. (1999) Regulatory Aspects of Stability Testing in Europe. Drug Dev. Ind. Pharm. 25:831-856.
42. Mischler PG. (2002) Developing Stability Protocols for Global Product Registrations-An Update. Presentation at International Seminar on Stability Testing: Design and Interpretation for International Registration, IBC Life Sciences, London.
43. Singh S., Bakshi M. (2000) Guidance on conduct of stress test to determine inherent stability of drugs. Pharm Technol Asia, 24-36.
44. Singh S, Bakshi M. (2002) Development of stability-indicating assay methods-A critical review. J. Pharm. Biomed. Anal. 28:1011-1040.
45. Singh S., Bhutani H., Mariappan TT. (2002) Behaviour of Uptake of Moisture by Drugs and Excipients under Accelerated Conditions of Temperature and Humidity in the Absence and the Presence of light. 1. Pure Anti- Tuberculosis Drugs and their Combinations. Int. J. Pharm. 245:37-44
46. Singh S. (1999) Drug Stability Testing and Shelf-life Determination According to International Guidelines. Pharm. Technol. 23:68-88
47. Singh S. (2000) Stability testing during product development in Jain NK Pharmaceutical product development CBS publisher and distributors. India, 272-293.
48. U.S. Pharmacopoeial Convention (1995), Inc., The United States Pharmacopoeia 23/National Formulary 18, Author, Rockville, MD, 11, 1940-1941, 1959-1963.
49. WHO. (2004) Stability studies in a global environment. Geneva meeting working document QAS/05.146 with comments.
50. Tembhare Ekta, Gupta R K (2019) An Approach to Drug Stability Studies and Shelf-life Determination, Archives of Current Research International , 19(1): 1-20.