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    
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.
Anthony M Cundell
Related Documents :
7706924 - Rhabdomyoma of the larynx: a review of the literature with a summary of previously desc...
15003484 - Ovarian papillary cystadenocarcinomas in a green iguana (iguana iguana).
2744914 - Retroperitoneal liposarcoma simulating a prolapsed intervertebral disc. a case report.
18795594 - Management of diffuse glioma in children: a retrospective study of 27 cases and review ...
25135824 - Psoriasis, anti-tumor necrosis factor therapy, and tuberculosis: report of three challe...
12608164 - Neisseria subflava as a cause of meningitis and septicemia in children. report of five ...
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.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Design, Solid-Phase Synthesis, and Evaluation of a Phenyl-Piperazine-Triazine Scaffold as ?-Helix Mi...
Next Document:  Comparison of different incubation conditions for microbiological environmental monitoring.