PT  - JOURNAL ARTICLE
AU  - Anthony M. Cundell
TI  - Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
AID  - 10.5731/pdajpst.2014.00997
DP  - 2014 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 386--393
VI  - 68
IP  - 5
4099  - http://journal.pda.org/content/68/5/386.short
4100  - http://journal.pda.org/content/68/5/386.full
SO  - PDA J Pharm Sci Technol2014 Sep 01; 68
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.