Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
| Autor: | Anthony M. Cundell |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Quality Control
Intoxicative inhalant Drug Compounding Pharmaceutical Science Excipient Excipients chemistry.chemical_compound Administration Inhalation Critical to quality medicine Humans Technology Pharmaceutical Food science Lactose Inhalation Chemistry Dry Powder Inhalers Lactulose Endotoxins Pharmaceutical Preparations Consumer Product Safety Dry powder Bacterial endotoxin Patient Safety Drug Contamination Critical quality attributes medicine.drug |
| Zdroj: | PDA Journal of Pharmaceutical Science and Technology. 68:386-393 |
| ISSN: | 1079-7440 |
| DOI: | 10.5731/pdajpst.2014.00997 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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