Small molecule parenteral drugs: Practical aspects of stress testing

Pharmaceutical Stress Testing: Predicting Drug Degradation: Second Edition

Volumn , Issue , 2016, Pages 322-341

  Abend, Andreas ^a   Duersch, Brett ^a   Fiszlar, Kyle ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84885841410     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9781439801802-16     Document Type: Chapter

References (51)

1. Nail SL. Physical and chemical stability considerations in the development and stress testing of freeze-dried pharmaceuticals. In: Baertschi SW, ed. Pharmaceutical Stress Testing. Vol. 153, New York:Taylor & Francis, 2005: 261-91.
2. Fasani E, Albini, A. Photostability Stress testing. In: Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, Taylor & Francis, 2005: 293-319.
3. Antipas AS, Landis, Margaret S. Solid State Excipient Compatibility Testing. In: Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, New York: Taylor & Francis, 2005: 419-58.
4. Clapham D, Templeton, Allen C. Practical aspects of conducting photostability stress testing. In:Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, New York: Taylor & Francis, 2005: TBD.
5. Q1B. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Stability Testing: Photostability Testing of New Drug Substances and Products Q1B, 1996.
6. Reed RA, Harmon P, Manas D, et al. The role of excipients and package components in the photostability of liquid formulations. PDA J Pharm Sci Technol 2003; 57: 351-68.
7. Q3B(R2). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. ICH Harmonised Tripartite Guideline: Impurities in New Drug Q3B(R2), 2006.
8. Q1A(R2). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products Q1A(R2), 2003.
9. Abrahamson HB, Rezvani, AB, Brushmiller G. Photochemical and spectroscopic studies of complexes of iron(III) with citric acid and other carboxylic acids. Inorg Chim Acta 1994; 226: 117-27.
10. Faust B, Zepp, RG. Photochemistry of aqueous iron(III)-polycarboxylate complexes: roles in the chemistry of atmospheric and surface waters. Environ Sci Tech 1993; 27: 2517-22.
11. Haber FaW, J. Über die Katalyse des Hydroperoxydes. Naturwissenschaften 1932.
12. Jennings TA. Lyophilization: Introduction and Basic Principles. Vol. 1, Buffalo Grove, IL, USA:Interpharm Press, 1999.
13. USP <789> Particle Matter in Injections.
14. Cernik M. Stability of pharmaceutical products. CHEMagazin 2009; 19: 32-4.
15. Baertschi SW, Alsante, Karen M. Stress testing: relation to the development imeline. In: Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, New York: Taylor & Francis, 2005: 173-9.
16. Nussbaum MA, Jansen, Patrick J, Baertschi, Steven W. Role of “mass balance” in pharmaceutical stress testing. In: Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, New York: Taylor & Francis, 2005: 181-204.
17. Boccardi G, Harmon, Paul A. Oxidative suscecptibility testing. In: Baertschi SW, ed. Drugs and the Pharmaceutical Sciences. Vol. 153, New York: Taylor & Francis, 2005: 205-34.
18. Carlson E, Chandler W, Galdo I, Kudla T, Ta C. Automated integrated forced degradation and drug-excipient compatibility studies. JALA 2005; 10: 374-80.
19. Zoglio MA. Preformulation stability testing of parenteral products. Bull Parenter Drug Assoc 1968; 22:295-8.
20. Degradation pathways of drug molecule A.
21. Wasylaschuk WR, Harmon PA, Wagner G, et al. Evaluation of hydroperoxides in common pharmaceutical excipients. J Pharm Sci 2006; 96: 106-16.
22. Pikal MJ, Dellerman K, Roy ML. Formulation and stability of freeze-dried proteins: effects of moisture and oxygen on the stability of freeze-dried formulations of human growth hormone. Dev Biol Stand 1991; 74: 21-38.
23. Kristensen S. Photostability of parenteral products. In: H.H. T, ed. Photostability of Drugs Drug Formulations, 2nd edn. Oslo: Taylor & Francis, 2004: 303-30.
24. Templeton AC, Bowen WE, Klein LJ, Harmon PA, Lu Y, Reed RA. Unexpected photochemistry in pharmaceutical products: a review on the role of diluents, excipients, and product components in promoting pharmaceutical photochemistry. Drugs Pharm Sci 2007; 163: 223-51.
25. Ludwig JD NPD, Davis CW. Automated method for determining Instron residual seal force of glass vial/rubber closure systems. J Parenter Sci Technol 1993; 5: 211-53.
26. Burrel LS CMW, DeMuth GE, Lambert WJ. Development of a dye ingress method to assess containerclosure integrity: correlation to microbial ingress. PDA J Pharm Sci Technol 2000; 54: 449-55.
27. Bergquist PA, Zimmerman J, Kenney RR, Han RY-H, Hunke WA. Stability of tirofiban hydrochloride in three commonly used I.V. Solutions and polyvinyl chloride administration sets. Am J Health-Syst Pharm 1999; 56: 1627-9.
28. Moore DE. Photophysical and photochemical aspects of drug stability. In: Tonnesen HH, ed. Photostability of Drugs and Drug Formulations. Oslo: Taylor & Francis (London, UK), 1996: 9-38.
29. Templeton AC, Xu H, Placek J, Reed RA. Implications of photostability on the manufacturing, packaging, storage, and testing. Drugs Pharm Sci 2005: 68-86.
30. Bergquist PA, Manas D, Hunke WA, Reed RA. Stability and compatibility of tirofiban hydrochloride during simulated Y-site administration with other drugs. Am J Health-Syst Pharm 2001; 58:1218-23.
31. Corveleyn S, De Smedt S, Remon JP. Moisture absorption and desorption of different rubber lyophilisation closures. Int J Pharm. 1997; 159: 57-65.
32. Pikal MJ, Shah S. Moisture transfer from stopper to product and resulting stability implications. develop Biol Standard 1991; 74: 165-79.
33. Vromans H, van Laarhoven JAH. A study on water permeation through rubber closures of injection vials. Int J Pharm. 1992; 79: 301-8.
34. VanAmerogan GJ. Diffusion in elastomers. Rubber Chem Technol 1964; 37: 1065-152.
35. Solomun L, Ibric S, Boltic Z, Djuric Z, Stupar B. The impact of primary packaging on the quality of parenteral products. J Pharm Biomed Anal 2008; 48: 744-8.
36. Abend A. RRA, Templeton A, C. Impact of stopper dryness for lyophilized drug products. Am Pharm Rev 2006; 6: 35-8.
37. Buck AL. New equations for computing vapor pressure and enhancement factor. J Appl Meterol 1981; 20: 1529.
38. Perry RHaG, D.W. Perry’s Chemical Engineer’s Handbook. In: Perry RHaG, DW, ed., New York:McGraw-Hill, 2007.
39. Templeton AC, Placek J, Xu H, Mahajan R, Hunke WA, Reed RA. Determination of the moisture content of bromobutyl rubber stoppers as a function of processing: implications for the stability of lyophilized products. PDA J Pharm Sci Technol 2003; 57: 75.
40. Wang YJ, Dahl TC, Leesman GD, Monkhouse DC. Optimization of autoclave cycles and selection of formulation for parenteral products: part II. Effect of counter-ion on pH and stability of diatrizoic acid at autoclave temperatures. J Parenter Sci Technol 1984; 38: 72-7.
41. Held HR, Landi S. Water permeability of elastomers. J Biol Stand 1977; 5: 111-19.
42. Carlisle CB, Cooper DE. Tunable diode laser frequency modulation spectroscopy through an optical fiber: high-sensitivity detection of water vapor. Appl Phys Lett 1990; 56: 805-7.
43. Carstensen JT. Effect of moisture on the stability of solid dosage forms. Drug Dev Ind Pharm 1988; 14:1927-69.
44. Zhang X, Kirsch LE. An assessment of techniques for evaluating the physical stability of parenteral emulsions. PDA J Pharm Sci Technol 2003; 57: 300-15.
45. Li LC, Parasrampuria J, Bommireddi A, Pec E, Dudleston A, Mayoral J. Moist-heat sterilization and the chemical stability of heat-labile parenteral solutions. Drug Dev Ind Pharm 1998; 24: 89-93.
46. Masson G, Trottet B. Physical stability of sterilized oil-in-water emulsions intended for total parenteral nutrition. Rev Fr Corps Gras 1984; 31: 391-4.
47. Canada T. Nutr Clin Pract 2006; 21: 636-7.
48. Driscoll DF. Formulation of parenteral and enteral admixtures. Update Intensive Care Emerg Med 2000; 34: 138-50.
49. Driscoll DF, Ling, Pai-Ra, Bistrian, Bruce R. J Parenter Enteral Nutr, 2007; 31: 148-53.
50. Dennis Ka. Biochemistry 1981; 20: 6079-85.
51. Herman and Groves. J Pharm Phamacol 1992; 44: 539-42.