Contact allergy induced by bisphenol A diglycidyl ether leachables from aluminium tubes for pharmaceutical use.

Abstract

BACKGROUND:

Aluminium tubes for pharmaceutical use are internally lacquered with epoxy resins (ER) based on bisphenol A diglycidyl ether (BADGE). Recently, it was shown that remnants of ER polymerization like BADGE are extractable from epoxy-based coatings of commercially available tubes and may leach into semi-solid drug preparations. We aimed to evaluate the safety of BADGE-contaminated macrogol ointments in individuals sensitized to ER based on BADGE by use tests.

METHODS:

Repeated open application testing (ROAT) in 11 patients sensitized to ER based on BADGE with BADGE in macrogol ointments (3 mg/kg; 30 mg/kg, equivalent to BADGE concentration determined in macrogol ointment after storage in a commercially available tube; 300 mg/kg).

RESULTS:

The 30 mg/kg BADGE ointment elicited reactions in three patients, and another three patients reacted to 300 mg/kg BADGE ointment. No reactions to the vehicle control and 3 mg/kg BADGE were observed.

CONCLUSIONS:

Elevated BADGE concentrations in ER-coated aluminium tubes pose a risk of developing contact dermatitis to patients sensitized to ER based on BADGE. Quality standards are deemed necessary for the production of ER-coated aluminium tubes intended for pharmaceutical use and should consider the results of the present ROAT study.

• Authors: K Breuer, C Lipperheide, U Lipke, T Zapf, H Dickel, R Treudler, S Molin, V Mahler, C Pföhler, H Löffler, H Schwantes, A Schnuch
• Journal: Allergy (Allergy) Vol. 70 Issue 2 Pg. 220-6 (Feb 2015) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 25582652 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Benzhydryl Compounds
• Epoxy Compounds
• Ointments
• Aluminum
• 2,2-bis(4-glycidyloxyphenyl)propane

Topics

• Adult
• Aged
• Aluminum (chemistry)
• Benzhydryl Compounds (adverse effects, chemistry)
• Dermatitis, Allergic Contact (diagnosis, etiology)
• Epoxy Compounds (adverse effects, chemistry)
• Female
• Humans
• Male
• Middle Aged
• Ointments
• Patch Tests
• Young Adult