US 12,329,748 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 May 1, 2023, as Appl. No. 18/310,325.
Application 18/310,325 is a continuation of application No. 17/224,799, filed on Apr. 7, 2021, granted, now 11,679,101.
Application 18/310,325 is a continuation of application No. 16/460,125, filed on Jul. 2, 2019, granted, now 11,000,513, issued on May 11, 2021.
Claims priority of provisional application 62/693,635, filed on Jul. 3, 2018.
Claims priority of provisional application 62/693,283, filed on Jul. 2, 2018.
Prior Publication US 2023/0263781 A1, Aug. 24, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/496 (2006.01); A61K 9/00 (2006.01); A61K 31/335 (2006.01); A61K 31/436 (2006.01); A61K 31/4523 (2006.01); A61K 31/47 (2006.01); A61K 31/519 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/24 (2006.01); A61K 47/28 (2006.01); A61K 47/34 (2017.01); A61K 47/38 (2006.01); A61P 17/00 (2006.01); A61P 17/04 (2006.01); A61K 45/06 (2006.01)
CPC A61K 31/436 (2013.01) [A61K 9/0014 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/18 (2013.01); A61K 47/22 (2013.01); A61K 47/24 (2013.01); A61K 47/28 (2013.01); A61K 47/34 (2013.01); A61K 47/38 (2013.01); A61K 45/06 (2013.01)] 51 Claims
 
1. An anhydrous composition of a mTOR inhibitor comprising:
about 0.1 wt % to about 20 wt % of an mTOR inhibitor, wherein the mTOR inhibitor is selected from the group consisting of rapamycin (sirolimus), temsirolimus, everolimus, and combinations thereof,
about 80 wt % to about 99.9 wt % of a solvent selected from the group consisting of propylene glycol, benzyl alcohol, DMSO, propylene glycol monocaprylate, diethylene glycol monoethyl ether, tetrahydrofurfuryl alcohol polyethylene glycol ether, butylene glycol, diethylene glycol, triethylene glycol, polyethylene glycol, diisopropyl adipate, isopropyl alcohol, glycerol, and any combination thereof;
about 0.1 wt % to about 5 wt % of a gelling agent;
about 0.001 wt % to about 1 wt % of an antioxidant;
wherein the anhydrous composition is formulated for topical administration.