Skip to main content
SpringerLink
Log in

Stability of a second-generation cephalosporin veterinary mastitis formulation after electron beam irradiation

  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

Abstract

This study focused on the chemical stability of the cephalosporin {ie28-1} acid, sodium salt (cephem 1) formulation after electron beam (e-beam) irradiation. The cephem 1 concentrations of samples irradiated at 5, 10, and 15 kilograys for glass vials and low-density polyethylene (LDPE) cannula syringes were not statistically different from the concentrations of the nonirradiated control samples. Samples from each irradiation dose stored in controlled-temperature chambers at 5°C and 30°C for 24 months did not show any concentration changes within statistical limits compared with the nontreated samples. Samples from each irradiation dose stored at 40°C for 12 months also did not show any concentration changes within statistical limits compared with the nontreated samples. The percentage of related substances increased slightly with the increase in ebeam irradiation level and storage temperature, but this increase was within the proposed label claim of 90% to 110% (45–55 mg/g). In conclusion, e-beam sterilization did not affect the chemical stability of cephem 1 intramammary formulation in LDPE cannula syringes, suggesting that e-beam irradiation may be a feasible method for terminal sterilization of this cephem 1 formulation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. United States Food and Drug Administration, Irradiation in the Production, Processing and Handling of Food, Federal Register 21 CFR Part 179 page 64108, December 1997.

  2. Carlson K, Williams C, Lambert B, Tang F. Guidant Corporations Installation of the SureBeam® On-Site System. Radiation Phys. Chem., 2000;57(3–6): 619–623.

    Article  CAS  Google Scholar 

  3. Van Lancker M, Herer A, Cleland MR, Jongen Y, Abs M. The on beam application Rhodotron: an industrial high-voltage high-powered electron beam accelerator for polymers radiation processing. Nucl Instrum Methods Phys Res. 1999;Sect. B 151(1–4): 242–246.

    Article  Google Scholar 

  4. Li S, Zamansky I, Orlov I, Tyle P, Roy SD Preformulation studies for the development of a parenteral liquid formulation of an antitumor agent, AG337, PDA J. PharmSciTech. 1997;51(5):181–186.

    CAS  Google Scholar 

  5. Boess C, Bogl KW. Influence of radiation treatment on pharmaceuticals-a review: alkaloids, morphine derivatives, and antibiotics. Drug Dev Ind Pharm. 1996;22(6):495–529.

    Article  CAS  Google Scholar 

  6. Jacobs GP. Stability of cefazolin and other new cephalosporins following gamma irradiation. Int J Pharm. 1983;17(1):29–38.

    Article  CAS  Google Scholar 

  7. Health Canada. Process Validation: Irradiation Sterilization for Pharmaceuticals. Available at: www.hc-sc.gc.ca/hpb-dgps/therapeutic. Accessed October, 2001.

  8. Stern M. Packaging materials issues in irradiation processing of foods. in Proceedings Polyolefins XII International Conference, Houston, TX,, Society of Plastics Engineers, February 2000.

  9. Lencioni E, Travagli V, La Rosa C, Pitotti A, Fuochi PG. Sterilization of pharmaceutical products by accelerated electrons. Boll Chim Farm. 1995;134(3):146–149.

    CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Chemical and Biopharmaceutical Research, Elanco Animal Health, A Division of Eli Lilly and Company, 46140-0708, Greenfield, IN

    Pamela J. Johns, Michael Turberg & Kevin Willard

  2. Lilly Development Center, 11 rue Granbonpre, B-1348, Mont-St-Guibert, Belgium

    Daniel Matagne

  3. Lilly Technology Center-North, 46285, Indianapolis, IN

    David Cheesman

Authors
  1. Pamela J. Johns
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michael Turberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Kevin Willard
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Daniel Matagne
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. David Cheesman
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Pamela J. Johns.

Additional information

Published: November 19, 2001

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Johns, P.J., Turberg, M., Willard, K. et al. Stability of a second-generation cephalosporin veterinary mastitis formulation after electron beam irradiation. AAPS PharmSciTech 2, 23 (2001). https://doi.org/10.1208/pt020423

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1208/pt020423

Keywords

Search

Navigation