US 11,752,102 B2
Powder preparation for nasal administration
Koichi Minato, Kanagawa (JP); Tomoya Fujisawa, Kanagawa (JP); Kenji Shimizu, Kanagawa (JP); Takahisa Saito, Kanagawa (JP); Hiroya Yajima, Kanagawa (JP); and Kazuhiro Sasaki, Kanagawa (JP)
Filed by ASKA Pharmaceutical Co., Ltd., Tokyo (JP)
Filed on Dec. 20, 2021, as Appl. No. 17/556,354.
Application 17/556,354 is a continuation of application No. 16/760,075, granted, now 11,234,928, previously published as PCT/JP2018/043233, filed on Nov. 22, 2018.
Claims priority of application No. 2017-227133 (JP), filed on Nov. 27, 2017.
Prior Publication US 2022/0125716 A1, Apr. 28, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 31/568 (2006.01); A61K 47/38 (2006.01)
CPC A61K 9/0073 (2013.01) [A61K 31/568 (2013.01); A61K 47/38 (2013.01)] 7 Claims
1. A powder preparation for nasal administration, comprising: a particulate of a male steroid hormone as an active ingredient and a water-soluble polymer; wherein said particulate has a volume average particle size (D50) in the range of from of 50 μm to 300 μm as measured by a laser diffraction particle size analyzer, and wherein the particle size of each particle is an average of a major axis and a minor axis of the particle; wherein the powder preparation provides a maximum plasma concentration of the male steroid hormone in an adult male after administration to be not more than 15 ng/ml; wherein a weight ratio of the water-soluble polymer to the male steroid hormone is in the range of from 3:1 to 7:1; and wherein said powder preparation is free from a crystalline cellulose and a carboxymethylcellulose sodium.