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Forced degradation studies of corticosteroids with an alumina-steroid-ethanol model for predicting chemical stability and degradation products of pressurized metered-dose inhaler formulations.
MedLine Citation:
PMID:  22410760     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Zheng-Zhi Wu; Matthew L Thatcher; James K Lundberg; Mark K Ogawa; Cliffton B Jacoby; John L Battiste; Katherine A Ledoux
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-12
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  -     ISSN:  1520-6017     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Affiliation:
3M Drug Delivery Systems, 3M Center, St. Paul, Minnesota 55144-1000. zzwu1@mmm.com.
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