| Forced degradation studies of corticosteroids with an alumina-steroid-ethanol model for predicting chemical stability and degradation products of pressurized metered-dose inhaler formulations. | |
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MedLine Citation:
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PMID: 22410760 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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An alumina (Al(2) O(3) )-steroid-ethanol model is used for forced degradation testing of corticosteroids to predict chemical stability and degradation products in pressurized metered-dose inhaler (pMDI) solution formulations. The model involves an ethanolic solution of a test steroid with Al(2) O(3) , stressed at elevated temperatures to mimic the chemical interaction of drug, excipient, and packaging (an aluminum aerosol canister). The reactivity order of eight synthetic corticosteroids toward Al(2) O(3) -induced reactions is ranked with the stress model. The corticosteroids containing a C21-OH group possess the highest reactivity, suggesting that aluminum canisters with an inert interior coating are needed to stabilize their solution pMDIs. The Al(2) O(3) -induced degradation products and degradation pathways of a steroid containing C21-OH and triamcinolone acetonide are presented, and the role of Al(2) O(3) in the degradation pathways is briefly discussed. A potential degradation profile of beclomethasone dipropionate (BDP) established with an Al(2) O(3) -BDP-ethanol stress model is the same as the actual degradation profile of the BDP pMDI product, indicating that the model indeed predicts the degradation products. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci. |
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Authors:
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Zheng-Zhi Wu; Matthew L Thatcher; James K Lundberg; Mark K Ogawa; Cliffton B Jacoby; John L Battiste; Katherine A Ledoux |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-3-12 |
Journal Detail:
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Title: Journal of pharmaceutical sciences Volume: - ISSN: 1520-6017 ISO Abbreviation: - Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-3-13 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 2985195R Medline TA: J Pharm Sci Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2012 Wiley Periodicals, Inc. |
Affiliation:
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3M Drug Delivery Systems, 3M Center, St. Paul, Minnesota 55144-1000. zzwu1@mmm.com. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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