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Bacterial endotoxin requirements for dry powder inhalants and their excipients: are they critical quality attributes?
1Consulting Microbiologist, Scarsdale, NY tonycundell@gmail.com.
Abstract:
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.
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