The Role of Excipients and Package Components in the Photostability of Liquid Formulations

PDA Journal of Pharmaceutical Science and Technology

Volumn 57, Issue 5, 2003, Pages 351-368

  Reed, Robert A ^a   Harmon, Paul ^a   Manas, Denise ^a   Wasylaschuk, Walter ^a   Galli, Chris ^a   Biddell, Ryan ^a   Bergquist, Paul A ^a   Hunke, William ^a   Templeton, Allen C ^a   Ip, Dominic ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Fenton chemistry; Iron mediated photo oxidation; Parenterals; Photocatalytic; Photostability; Polycarboxylates

Indexed keywords

BUFFER; CARBOXYLIC ACID; CITRATE SODIUM; CITRIC ACID; EXCIPIENT; HYDROXYL RADICAL; IRON; OXYGEN; SILICATE; SODIUM CHLORIDE; TRANSITION ELEMENT; WATER;

ARTICLE; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SOLUTION; DRUG STABILITY; EXCIPIENT COMPATIBILITY; LIGHT EXPOSURE; PHARMACEUTICAL ENGINEERING; PHOTOCHEMISTRY; PHOTODEGRADATION; PHOTOOXIDATION; PHOTOSENSITIVITY; PREFORMULATION;

DRUG PACKAGING; DRUG STABILITY; EXCIPIENTS; IRON; LIGHT; PHARMACEUTICAL SOLUTIONS; ULTRAVIOLET RAYS;

EID: 10744232329     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. nd ed; Oxford University Press:, Oxford, UK, 1989; pp 36-104.
2. J. G. Neilands, Evolution of Biological Iron Binding Centers. Struct. Bonding 11, 145-170 (1972).
3. For example, see H. B. Abrahamson, A. B. Rezvani, G. Brushmiller, Photochemical and spectroscopic studies of complexes of iron (III) with citric acid and other carboxylic acids. Inorg. Chim. Acta. 226(1-2), 117-127 (1994), and references therein.
4. rd ed, Oxford University Press: Oxford, UK, 1991; pp 401-406.
5. B. Faust, R. G. Zepp, Photochemistry of Aqueous Iron (III)-Polycarboxylate Complexes: Roles in the Chemistry of Atmospheric and Surface Waters. Environ. Sci. Tech. 27(12), 2517-2522 (1993).
6. st ed; D. D. Eley, H. Pines, P. Weisz, Eds.; Academic Press: New York, NY, 1976; Vol. 25, pp 25-56.
7. J. J. Llorens-Molina, Photochemical reduction of Fe3+ by citrate ion. J. Chem. Educ. 65(12), 1090 (1988).
8. International Conference on Harmonization. Guidelines for the Photostability Testing of New Drug Substances and Products. Federal Register 62, 27115-27122 (1997).
9. P. Helboe, The Elaboration and Application of the ICH Guideline on Photostability: A European View. In Drugs: Photochemistry and Photostability; Royal Society of Chemistry: London, UK, 1998; pp 243-247.
10. S. R. Thatcher, R. K. Mansfield, R. B. Miller, C. W. Davis, S. W. Baertschi, Pharmaceutical Photostability: A Technical Guide and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability - Part 1. Pharmaceutical Technology 25(3), 98-110 (2001).
11. S. R. Thatcher, R. K. Mansfield, R. B. Miller, C. W. Davis, S. W. Baertschi, Pharmaceutical Photostability: A Technical Guide and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability - Part 2. Pharmaceutical Technology 25(4), 50-62 (2001).
12. For example, see (a) D. E. Moore, Photophysical and Photochemical Aspects of Drug Stability. In Photostability of Drugs and Drug Formulations; Taylor and Francis: London, UK, 1996; pp 9-38.
13. (b) K. Thoma, Photodecomposition and Stabilization of Compounds in Dosage Forms. In Photostability of Drugs and Drug Formulations; Taylor and Francis: London, UK, 1996; pp 111-140.
14. th edition; John Wiley & Sons: New York, NY, 1993; Vol. 4, pp 354-380.