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

Breuer K, Lipperheide C, Lipke U, Zapf T, Dickel H, Treudler R, Molin S, Mahler V, Pfoehler C, Loeffler H, Schwantes H, Schnuch A (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Allergy Wiley-Blackwell

Book Volume: 70

Pages Range: 220-6

Journal Issue: 2

DOI: 10.1111/all.12538

Abstract

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.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).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.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 with CRIS profile

Vera Mahler Medizinische Fakultät

Additional Organisation(s)

Department of Dermatology

Involved external institutions

Dermatologikum Hamburg DE Germany (DE) Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) / Federal Institute for Drugs and Medical Devices DE Germany (DE) Ruhr-Universität Bochum (RUB) DE Germany (DE) Universität Leipzig DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) Universität des Saarlandes (UdS) DE Germany (DE) SLK-Kliniken Heilbronn GmbH DE Germany (DE) BG Klinik Falkenstein DE Germany (DE) Georg-August-Universität Göttingen DE Germany (DE)

How to cite

APA:

Breuer, K., Lipperheide, C., Lipke, U., Zapf, T., Dickel, H., Treudler, R.,... Schnuch, A. (2015). Contact allergy induced by bisphenol A diglycidyl ether leachables from aluminium tubes for pharmaceutical use. Allergy, 70(2), 220-6. https://dx.doi.org/10.1111/all.12538

MLA:

Breuer, K., et al. "Contact allergy induced by bisphenol A diglycidyl ether leachables from aluminium tubes for pharmaceutical use." Allergy 70.2 (2015): 220-6.

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