US 12,268,673 B2
Anhydrous compositions of mTOR inhibitors and methods of use
Wesley Harton Kaupinen, Wayne, PA (US); Braham Shroot, Antibes (FR); Simon David Betson, Woking (GB); Charles Rodney Greenaway Evans, Mitcham (GB); and Marc Barry Brown, Watford (GB)
Assigned to PALVELLA THERAPEUTICS, INC., Wayne, PA (US)
Filed by PALVELLA THERAPEUTICS, INC., Wayne, PA (US)
Filed on Aug. 31, 2021, as Appl. No. 17/462,800.
Application 16/905,059 is a division of application No. 15/863,573, filed on Jan. 5, 2018, granted, now 10,722,499, issued on Jul. 28, 2020.
Application 17/462,800 is a continuation of application No. 16/905,059, filed on Jun. 18, 2020, granted, now 11,135,204.
Claims priority of provisional application 62/443,117, filed on Jan. 6, 2017.
Prior Publication US 2022/0016089 A1, Jan. 20, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/436 (2006.01); A61K 9/00 (2006.01); A61K 47/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/22 (2006.01); A61K 47/24 (2006.01); A61K 47/28 (2006.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01); A61P 17/00 (2006.01)
CPC A61K 31/436 (2013.01) [A61K 9/0014 (2013.01); A61K 47/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/22 (2013.01); A61K 47/24 (2013.01); A61K 47/28 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01); A61P 17/00 (2018.01)] 11 Claims
 
1. A method of treating diffuse microcystic lymphatic malformations in a subject in need thereof comprising topically administering to the affected areas of the subject an anhydrous gel composition, wherein the anhydrous gel composition comprises
2.5 wt % to about 4.5 wt % of rapamycin or a pharmaceutically acceptable salt thereof, based upon the total weight of the composition,
about 80 wt % to about 97 wt % of a solvent, based upon the total weight of the composition, wherein the solvent is about 1 wt % to about 30 wt % diisopropyl adipate based upon the total weight of the composition, about 1 wt % to about 30 wt % glycerol based upon the total weight of the composition, about 40 wt % to about 60 wt % polyethylene glycol based upon the total weight of the composition, and about 1 wt % to about 30 wt % isopropyl alcohol, based upon the total weight of the composition,
about 0.1 wt % to about 5 wt % of a gelling agent, based upon the total weight of the composition,
about 0.001 wt % to about 1 wt % of an antioxidant, based upon the total weight of the composition, and
optionally an additional pharmaceutically acceptable excipient,
wherein a total weight of the composition is 100 wt %, and
wherein the anhydrous gel composition has an apparent pH of about 4 to about 8.