Pharmacopeial methodologies for determining aerodynamic mass distributions of ultra-high dose inhaler medicines

Journal of Pharmaceutical and Biomedical Analysis
William WongPaul M Young

Abstract

Three different impactor methodologies, the Andersen cascade impactor (ACI), next-generation impactor (NGI) and multistage-liquid impinger (MSLI) were studied to determine their performance when testing ultra-high dose dry powder formulations. Cumulative doses of spray-dried mannitol (Aridol) were delivered to each impactor at a flow rate of 60Lmin(-1) (up to a max dose of 800mg delivering 20 sequential 40mg capsules). In general, total drug collected in both the ACI and NGI falls below the range 85-115% of label claim criteria recommended by the United States of America Food and Drug Administration (FDA) at nominal mannitol doses exceeding 20mg and 200mg, respectively. In comparison analysis of the MSLI data, over a 5-800mg cumulative dosing range, indicated that the percentage of nominal dose recovered from the MSLI was within the +/-15% limits set in this study. Furthermore all samples, apart from the 5mg and 10mg analysis were within 5% of the nominal cumulative dose. While the MSLI is not routinely used for regulatory submission, the use of this impinger when studying ultra-high dose formulations should be considered as a complementary and comparative source of aerosol deposition data.

References

Mar 1, 1966·American Industrial Hygiene Association Journal·A A Andersen
Oct 6, 1997·American Journal of Respiratory and Critical Care Medicine·S D AndersonA R Clark
Jan 13, 1998·The European Respiratory Journal·E DaviskasG Bautovich
Jun 27, 2001·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·J N Pritchard
Jun 12, 2003·The European Respiratory Journal·K S BabuJ H Conway
Oct 24, 2003·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·Virgil A MarpleDieter Hochrainer
Aug 6, 2004·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·Paul M YoungRobert Price
Nov 30, 2004·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Toshiomi NakateYoshiaki Kawashima
Jul 19, 2005·International Journal of Pharmaceutics·Craig DunbarTiba Tiangbe
Dec 2, 2006·Nature Reviews. Drug Discovery·Erik De Clercq

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Citations

Jun 26, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Kamrun NaharFakhrul Ahsan
Sep 6, 2013·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Paul M YoungDaniela Traini
Oct 28, 2015·Journal of Pharmaceutical Sciences·Iman AlfagihImran Y Saleem
Sep 4, 2012·International Journal of Pharmaceutics·Floris GrasmeijerAnne H de Boer
Apr 21, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·M AlsaadiK C Carter
Jul 24, 2015·The Journal of Antimicrobial Chemotherapy·M Moreno-SastreJ L Pedraz
May 2, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Hui Xin OngPaul M Young
Feb 25, 2014·International Journal of Pharmaceutics·Seyed Salman Razavi RohaniMohsen Tafaghodi
Sep 30, 2016·The AAPS Journal·Thaigarajan ParumasivamHak-Kim Chan
Jan 5, 2013·Jornal brasileiro de pneumologia : publicaça̋o oficial da Sociedade Brasileira de Pneumologia e Tisilogia·Marina Andrade-LimaAna Luisa Godoy Fernandes

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