US 12,186,427 B2
Fulvestrant formulations and methods of their use
Feng-Jing Chen, Irvine, CA (US); Steven L. Krill, Midland Park, NJ (US); Rama Abu Shmeis, Branchburg, NJ (US); Adrian Hepner, Ramsey, NJ (US); Charles Wescott, Woodcliff Lake, NJ (US); Tara Jaskowski, Woodcliff Lake, NJ (US); and Michael Joyce, Woodcliff Lake, NJ (US)
Assigned to Eagle Pharmaceuticals, Inc., Woodcliff Lake, NJ (US)
Filed by EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ (US)
Filed on Feb. 14, 2023, as Appl. No. 18/109,421.
Application 18/109,421 is a continuation of application No. 16/762,229, previously published as PCT/US2018/059906, filed on Nov. 8, 2018.
Claims priority of provisional application 62/583,403, filed on Nov. 8, 2017.
Prior Publication US 2023/0404918 A1, Dec. 21, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/10 (2006.01); A61K 9/00 (2006.01); A61K 31/519 (2006.01); A61K 31/566 (2006.01); A61K 47/24 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01)
CPC A61K 9/10 (2013.01) [A61K 9/0019 (2013.01); A61K 31/519 (2013.01); A61K 31/566 (2013.01); A61K 47/24 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01)] 18 Claims
 
1. An aqueous suspension comprising:
solubilized fulvestrant;
non-solubilized fulvestrant particles having one or more of:
a laser diffraction diameter (10) LD Dv (10) between about 1.5 microns and about 2.1 microns,
an LD Dv (50) between about 5.5 microns and about 9.0 microns, and
an LD Dv (90) between about 15 microns and about 35 microns;
a surfactant;
a polyvinylpyrrolidone; and
a sugar alcohol; and
a water-soluble excipient that is:
an aryl-C1-6alk-OH,
a C1-6alkyl-OH,
a buffering salt,
a polysorbate,
a polyalkylene glycol,
a C1-12alkylene glycol,
a phosphatidylcholine,
or a combination thereof.