US 11,806,314 B2
PDE5 inhibitor powder formulations and methods relating thereto
Zhen Xu, Albuquerque, NM (US); Hugh Smyth, West Lake Hills, TX (US); Aileen Gibbons, New York, NY (US); Revati Shreeniwas, Palo Alto, CA (US); Pravin Soni, Sunnyvale, CA (US); Dan Deaton, Apex, NC (US); James Hannon, Albuquerque, NM (US); Stephen Lermer, Austin, TX (US); Robert Curtis, Santa Fe, NM (US); and Martin J. Donovan, Austin, TX (US)
Assigned to Respira Therapeutics, Inc., Palo Alto, CA (US)
Filed by Respira Therapeutics, Inc., Palo Alto, CA (US)
Filed on Jan. 20, 2022, as Appl. No. 17/579,981.
Application 17/579,981 is a continuation of application No. 17/211,071, filed on Mar. 24, 2021.
Application 17/211,071 is a continuation of application No. 15/102,957, abandoned, previously published as PCT/US2014/069392, filed on Dec. 9, 2014.
Claims priority of provisional application 61/913,734, filed on Dec. 9, 2013.
Claims priority of provisional application 61/913,744, filed on Dec. 9, 2013.
Prior Publication US 2022/0143034 A1, May 12, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/53 (2006.01); A61K 9/00 (2006.01); A61K 47/26 (2006.01); A61K 31/4985 (2006.01); A61K 31/506 (2006.01); A61K 31/519 (2006.01); A61K 31/166 (2006.01); A61M 15/00 (2006.01)
CPC A61K 31/53 (2013.01) [A61K 9/0075 (2013.01); A61K 31/166 (2013.01); A61K 31/4985 (2013.01); A61K 31/506 (2013.01); A61K 31/519 (2013.01); A61K 47/26 (2013.01); A61M 15/0008 (2014.02); A61M 2202/064 (2013.01)] 37 Claims
 
1. A pharmaceutical composition, comprising at least about 2% to about 20% by weight of a micronized hydrochloride salt of vardenafil based on the total weight of the pharmaceutical composition, wherein the micronized hydrochloride salt of vardenafil has a Dv50 of about 5 microns or less, and lactose having an average particle size between about 2 microns to about 250 microns and comprising a fine lactose fraction from about 2% to about 50% by weight of the total lactose component, wherein the fine lactose fraction has a particle size of less than 7 microns, and wherein the pharmaceutical composition is in dry powder form suitable for oral inhalation.