title: Bacterial endotoxin requirements for dry powder inhalants and their excipients: are they critical quality attributes?
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.
authors.affiliation: Consulting Microbiologist, Scarsdale, NY tonycundell@gmail.com.
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Cundell
mesh_terms: D000280:Administration, Inhalation; D003257:Consumer Product Safety; D004339:Drug Compounding; D004340:Drug Contamination / Q000517:prevention & control*; D058995:Dry Powder Inhalers; D004731:Endotoxins / Q000032:analysis*; D005079:Excipients / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D006801:Humans; D007792:Lactulose / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards
chemical_list: D004731:Endotoxins; D005079:Excipients; D004364:Pharmaceutical Preparations; D007792:Lactulose