Foreign particles testing in orally inhaled and nasal drug products.
The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) presents this paper in order to contribute to public discussion regarding best approaches to foreign particles testing in orally inhaled and nasal drug products (OINDPs) and to help facilitate development of consensus views on this subject. We performed a comprehensive review of industry experience and best practices regarding foreign particles testing in OINDPs, reviewed current guidances and techniques, and considered health and safety perspectives. We also conducted and assessed results of an industry survey on U.S. Food and Drug Administration requirements for foreign particles testing. We provide here a result of our review and survey: a summary of industry best practices for testing and controlling foreign particles in OINDPs and proposals for developmental characterization and quality control strategies for foreign particles. We believe that clear consensus-based recommendations and standards for foreign particles testing and control in OINDPs are needed. The proposals contained in this paper could provide a starting point for developing such consensus recommendations and standards.
Blanchard
James
J
Coleman
James
J
Hayling
Claire D'Abreu
CD
Ghaderi
Raouf
R
Haeberlin
Barbara
B
Hart
John
J
Jensen
Steen
S
Malcolmson
Richard
R
Mittelman
Stanley
S
Nagao
Lee M
LM
Sekulic
Sonja
S
Snodgrass-Pilla
Caesar
C
Sundahl
Mikael
M
Thompson
Glenn
G
Wolff
Ronald
R
D000280:Administration, Inhalation; D000281:Administration, Intranasal; D000818:Animals; D004340:Drug Contamination; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D006801:Humans; D036501:Metered Dose Inhalers; D004364:Pharmaceutical Preparations / Q000032:analysis*
D004364:Pharmaceutical Preparations