RT Journal Article
SR Electronic
T1 Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 386
OP 393
DO 10.5731/pdajpst.2014.00997
VO 68
IS 5
A1 Cundell, Anthony M.
YR 2014
UL http://journal.pda.org/content/68/5/386.abstract
AB 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.