A REVIEW ON STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

  • ZOTHANPUII F Department of Pharmaceutical Analysis, Acharya and BM Reddy College of Pharmacy, Bengaluru, Karnataka, India.
  • RAJESH R Department of Pharmaceutical Analysis, Acharya and BM Reddy College of Pharmacy, Bengaluru, Karnataka, India.
  • SELVAKUMAR K Department of Pharmaceutical Analysis, Acharya and BM Reddy College of Pharmacy, Bengaluru, Karnataka, India.

Abstract

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

Keywords: Stability studies, International Conference of Harmonization guidelines, Pharmaceutical products, Shelf life

References

1. Arunachalam A, Shankar M. Stability studies. Asian J Pharm Anal Med Chem 2008;1:184-95.
2. Naveed S, Basheer S, Qamar F. Stability of a dosage form and forced degradation studies. J Bioequivalence Bioavailab 2016;8:191-3.
3. Kommanaboyina B, Rhodes CT. Trends in stability testing, with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 1999;25:857-68.
4. Bhuyian HU, Rashid HA, Mohsin MD, Tahera KT. Stability study of pharmaceutical products and shelf-life prediction. Eur J Biomed Pharm Sci 2015;2:30-40.
5. Sengupta P, Chatterjee B, Tekade RK. Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: A comprehensive review. Int J Pharm 2018;543:328-44.
6. Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical products. J Appl Pharm Sci 2012;2:129-38.
7. Maheshwari R, Kar M, Chourasiya Y. Stability and degradation studies for drug and drug product. Dosage Form Des Considerations 2018;1:225-57.
8. Quadri SS, Sonwane LV, Poul B, Kamshette S. Review on stability indicating assay methods. Pharma Tutor 2014;2:16-31.
9. Komka K, Kemeny S. A modified error model for the assessment of stability of pharmaceutical products. Chemometr Intell Lab Syst 2004;72:161-5.
10. Blessy M, Ruchi DP, Prajesh NP, Agrawal YR. Development of forced degradation and stability indicating studies of drugs. J Pharm Anal 2014;4:159-65.
11. Thorat P, Warad S, Solunke R, Ashok S, Anagha B, Asha S, et al. Stability study of dosage form: An inovative step. World J Pharm Pharm Sci 2014;3:1031-50.
12. Freed AL, Colgan ST, Kochling JD, Alasandro MS. Accelerating pharmaceutical development through predictive stability approaches. AAPS J 2017;3:2-10.
13. Khushbu M, Thakor A, Bhavsar DD, Thakor JR. Development of forced degradation and stability indicating studies for drug substance and drug product. Int J Res Pharmacol Pharmacother 2016;55:291-7.
14. Bhaskar R, Ola M, Agnihotri V, Chavan A, Girase H. Current trend in performance of forced degradation studies for drug substance and drug products. J Drug Deliv Ther 2020;10:149-55.
15. Suthar N, Choudhary M. A review on stability studies of pharmaceutical products. Int J Appl Pharm Biol Res 2017;2:67-75.
16. Agarwal V, Sharma D. Stability testing of active pharmaceutical and scientific innovation. J Pharm Sci Innov 2012;1:18-23.
17. Tollefson AE, Hermiston TW, Lichtenstein DL, Colle CF, Tripp RA. Forced degradation of fast inhibits apoptosis in adenovirus-infected cells. Nature 1998;392:726-30.
18. Bakshi M, Singh S. Development of validated stability-indicating assay methods-critical review. J Pharm Biomed Anal 2002;28:1011-40.
19. Marin A, Barbas C. LC-MS for the degradation profiling of cough-cold products under forced conditions. J Pharm Biomed Anal 2004;35:1035-45.
20. Singh S, Junwal M, Modhe G, Tiwari H, Kurmi M. Forced degradation studies to assess the stability of drugs and products. Trends Analyt Chem 2013;49:71-88.
21. Haystead JS. Stability testing. Pharm Technol 2004;28:130.
22. Colgan ST, Timpano RJ, Roberts M. Opportunities for lean stability strategies. J Pharm Sci Innov 2014;9:259-71.
23. Singh R, Rehman ZU. Current trends in forced degradation study for pharmaceutical product development. J Pharm Educ Res 2012;3:54-63.
24. Andreson G, Scott M. Determination of product shelf life and activation for five drugs of abuse. Clin Chem 1991;37:398-402.
25. Chakole RD, Charde MS, Kumar J, Welankiwar AS. Development of forced degradation studies of drugs. Int J Adv Pharm 2013;2:34-9.
26. Hotha KK, Reddy SP, Raju VK, Ravindranath LK. Overview of regulatory guidance and literature for the drug products and drug substances. Int Res J Pharm 2013;4:78-85.
27. Kaur M, Kaur G, Kaur H, Sharma S. Overview on stability studies. Int J Pharm Chem Biol Sci 2013;3:1231-41.
28. World Health Organization. Stability Studies in a Global Environment. Geneva: World Health Organization; 2004.
29. Veszelszki A. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Tech Rep Ser 2018;10:309-52.
30. Singh S. Stability testing during product development. In: Jain NK. Pharmaceutical Product Development. India: CBS Publisher; 2000. p. 272-93.
31. Pokharana M, Vaishnav R, Goyal A, Shrivastava A. Stability testing guidelines of pharmaceutical products. J Drug Deliv Ther 2018;8:169-75.
32. International Conference on Harmonization. Guideline on Stability Testing of New Drug Substances and Products, Q1A (R2); 2003. Available from: https://www.database.ich.org/sites/default/files/ q1a28r22920guideline.pdf. [Last accessed on 2020 Mar 20].
33. International Conference on Harmonization. Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B; 1996. Available from: https://www.database.ich.org/sites/default/files/q1b20guideline.pdf. [Last accessed on 2020 Mar 20].
34. International Conference on Harmonization. Stability Testing for New Dosage Forms, Q1C; 1996. Available from: https://www.database.ich.org/ sites/default/files/Q1C20Guideline.pdf. [Last accessed on 2020 Mar 20].
35. International Conference on Harmonization. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Q1D; 2002. Available from: https://www.database.ich.org/sites/default/ files/q1d20guideline.pdf. [Last accessed on 2020 Mar 20].
36. Munden RP. ICH Q1D: ICH Quality Guideline; 2017. p. 73-87.
37. International Conference on Harmonization. Evaluation for Stability Data, Q1E; 2003. Available from: https://www.database.ich.org/sites/ default/files/q1e20guideline.pdf. [Last accessed on 2020 Mar 20].
38. International Conference on Harmonization. Stability Data Package for Registration Application in Climatic Zone III and IV, Q1F; 2018. Available from: https://www.database.ich.org/sites/default/files/q1f_ stability_guideline_who_2018.pdf. [Last accessed on 2020 Mar 20].
39. International Conference on Harmonization. Stability Testing of Biotechnological/Biological Products, Q5C; 1995. Available from: https://www.database.ich.org/sites/default/files/q5c20guideline.pdf. [Last accessed on 2020 Mar 20].
40. Hasija, M, Aboutorabian, S, Rahman, N Ausar, SF. Practical approaches to forced degradation studies of vaccines. Methods Mol Biol 2016;1403:853-66.
41. International Conference on Harmonization. GMP Guide for Active Ingredients, Q7; 2000. Available from: https://www.database.ich.org/ sites/default/files/q720guideline.pdf. [Last accessed on 2020 Mar 20].
42. European Medicines Agency. Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products, CPMP/QWP/122/02. Amsterdam: European Medicines Agency; 2003. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-stability-testing-existing-active-substances-related-finished-products_en.pdf. [Last accessed on 2020 Apr 02].
43. Bott RF, Oliveira WP. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev Ind Pharm 2007;33:393-401.
44. Grimm W. Extension of the international conference on harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV. Drug Dev Ind Pharm 1998;24:313-25.
45. World Health Organization. Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series; 2009. Available from: https://www.extranet.who.int/ prequal/sites/default/files/documents/trs1010_annex10.pdf. [Last accessed on 2020 Apr 02].
46. Ali J, Khar RK, Ahuja A. Dosage form and Design. 3rd ed. Delhi: Birla Publications Pvt. Ltd.; 2008. p. 100-23.
47. Baertschi SW. Pharmaceutical Stress Testing. Predicting Drug Degradation. India: CRC Press; 2005.
48. Zimmer M. Forced degradation and long-term stability testing for oral drug products. In: Methods for Stability Testing of Pharmaceuticals. Methods in Pharmacology and Toxicology. New York: Humana Press; 2018. p. 75-98.
49. Ruben SR. Stability studies. Asian J Pharm Anal Med Chem 2014;2:51-62.
50. Carstensen JT. Drug Stability: Principles and Practices. New York: Marcel Dekker; 2000.
51. Mischler PG. Developing Stability Protocols for Global Product Registrations-an Update. London: IBC Life Sciences; 2002. p. 13-4.
52. Reynolds DW, Facchine KL, Mullaney JF, Alsante KM, Hatajik TD, Motto MG, et al. Conducting forced degradation studies. Pharm Technol 2002;26:48-56.
53. Bhutani H, Singh S, Mariappan TT, Kaur H, Bajaj M, Pakhale S, et al. Behavior of uptake of moisture by drugs and excipients under accelerated conditions of temperature and humidity in the absence and the presence of light. Pharm Technol 2003;27:44-52.
54. Gaur A. A possible reason for the generation of out of trend stability results: Variable air velocity at different locations within the stability chamber. Pharm Technol 2005;29:46-9.
55. Singh A, Singh P. Technical considerations of forced degradation studies of new drug substances and product: Regulatory perspectives. J Drug Deliv Ther 2018;8:163-8.
56. Singh DK, Singh S, Bajaj S. Methods for stability testing of pharmaceuticals. In: Methods in Pharmacology and Toxicology. New York: Springer; 2018. p. 1-30.
57. Kailash VV, Parkar B, Ghude K, Acharekar S. Recent trends in stability testing of pharmaceutical products: A review. J Pharm Biol Chem Sci 2015;6:1557-63.
Statistics
42 Views | 49 Downloads
Citatons
How to Cite
F, Z., R. R, and S. K. “A REVIEW ON STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 10, Aug. 2020, pp. 3-9, doi:10.22159/ajpcr.2020.v13i10.38848.
Section
Review Article(s)