Granted Patent B2

US 12,370,199 · App. 17/379,534 · Granted Jul 29, 2025

Inventors: Feng-Jing Chen (Irvine, CA); Steven L. Krill (Midland Park, NJ); Rama Abu Shmeis (Branchburg, NJ)

Assignee: Eagle Pharmaceuticals, Inc.

A61K31/565A61K9/0019A61K9/08A61K9/10A61K9/14A61K31/519A61K45/06A61K47/10A61K47/26A61K47/32A61P35/00

Abstract

Claims (18)

1. A method of forming an aqueous fulvestrant suspension comprising:

mixing an aqueous medium and at least one stabilizer to form a suspension vehicle, the at least one stabilizer comprising:

a surfactant and

a polyvinylpyrrolidone, polyethylene glycol with an average molecular weight of about 3350 g/mol, a carboxymethylcellulose sodium, a non-electrolyte, or a combination thereof;

adding an amount of fulvestrant to the suspension vehicle; and

dispersing the fulvestrant in the suspension vehicle to form an aqueous fulvestrant suspension;

wherein the aqueous fulvestrant suspension comprises fulvestrant particles having one or more of:

a laser diffraction determined (LD) Dv(10) from about 1 micron to about 3 microns;

an LD Dv(50) from about 2 microns to about 35 microns; and

an LD Dv(90) from about 4 microns to about 120 microns;

and having one or more of:

a microscopy image capture determined (CE) Dv(90) from about 10 microns and about 200 microns;

a CE Dv(50) from about 5 microns to about 60 microns; and

CE Dv(10) from about 1 microns to about 25 microns.

2. The method of claim 1 , further comprising high pressure homogenizing the aqueous fulvestrant suspension.

3. The method of claim 2 , wherein the high pressure homogenization is performed at a pressure of about 15,000 psi to about 45,000 psi.

4. The method of claim 2 , further comprising adding an electrolyte to the homogenized aqueous fulvestrant suspension and mixing the electrolyte into the suspension.

5. The method of claim 2 , further comprising adding another non-electrolyte to the homogenized aqueous fulvestrant suspension and mixing the other non-electrolyte into the suspension.

Assignments (3)

Continuity (4)

References Cited (111)