Document Detail


Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
MedLine Citation:
PMID:  25336414     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
This review article considers whether bacterial endotoxin levels are a critical quality attribute for dry powder inhalants and their major excipient Lactose, NF. Based on international no-effect levels for workplace endotoxin exposure, the technical literature, typical indoor and outdoor airborne endotoxin levels, and manufacturing capabilities for Lactose, NF and dry powder inhalation products, a strong case is presented that bacterial endotoxin is not a critical quality attribute and endotoxin specifications are not required for inhalation products and their excipients.
Authors:
Anthony M Cundell
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Publication Detail:
Type:  REVIEW    
Journal Detail:
Title:  PDA journal of pharmaceutical science and technology / PDA     Volume:  68     ISSN:  1948-2124     ISO Abbreviation:  PDA J Pharm Sci Technol     Publication Date:    2014 9/10
Date Detail:
Created Date:  2014-10-22     Completed Date:  -     Revised Date:  2014-10-23    
Medline Journal Info:
Nlm Unique ID:  9439538     Medline TA:  PDA J Pharm Sci Technol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  386-393     Citation Subset:  -    
Copyright Information:
© PDA, Inc. 2014.
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