TY - JOUR
T1 - Agglomerate properties and dispersibility changes of salmeterol xinafoate from powders for inhalation after storage at high relative humidity
AU - Das, Shyamal Chandra
AU - Young, Paul M
AU - Larson, Ian Clair
AU - Stewart, Peter James
PY - 2009
Y1 - 2009
N2 - This study investigated changes in agglomeration and the mechanism of dispersibility decrease of salmeterol xinafoate (SX) from SX-lactose mixtures for inhalation after storage at 75 RH for 3 months. The dispersibility, PSD and in situ PSD of aerosol plumes of SX alone and SX-coarse lactose (CL) mixtures containing 0, 5, 10 and 20 micronized lactose (ML) before and after storage were determined by a Next Generation Impactor (NGI), a Mastersizer 2000 and a Spraytec, respectively. The PSD of ML increased after storage at 75 RH, but dispersibility of SX using the stored ML increased. After storage, the SX of the mixture containing 20 ML (M20F) significantly increased (P>0.05) in the throat and mouthpiece, preseparator and stage 1 of NGI, while it significantly decreased in the remaining stages (P>0.05). In situ analysis of aerosol plumes of M20F supported this result with an increased presence of particles of 4-25 -m and a decreased respirable particle distribution of
AB - This study investigated changes in agglomeration and the mechanism of dispersibility decrease of salmeterol xinafoate (SX) from SX-lactose mixtures for inhalation after storage at 75 RH for 3 months. The dispersibility, PSD and in situ PSD of aerosol plumes of SX alone and SX-coarse lactose (CL) mixtures containing 0, 5, 10 and 20 micronized lactose (ML) before and after storage were determined by a Next Generation Impactor (NGI), a Mastersizer 2000 and a Spraytec, respectively. The PSD of ML increased after storage at 75 RH, but dispersibility of SX using the stored ML increased. After storage, the SX of the mixture containing 20 ML (M20F) significantly increased (P>0.05) in the throat and mouthpiece, preseparator and stage 1 of NGI, while it significantly decreased in the remaining stages (P>0.05). In situ analysis of aerosol plumes of M20F supported this result with an increased presence of particles of 4-25 -m and a decreased respirable particle distribution of
U2 - 10.1016/j.ejps.2009.03.016
DO - 10.1016/j.ejps.2009.03.016
M3 - Article
SN - 0928-0987
VL - 37
SP - 442
EP - 450
JO - European Journal of Pharmaceutical Sciences
JF - European Journal of Pharmaceutical Sciences
IS - 3-4
ER -