US 12,433,839 B2
Sustained release particle formulations
Cory Berkland, Lawrence, KS (US); and Milind Singh, Apex, NC (US)
Assigned to ADARE PHARMACEUTICALS USA, INC., Lawrenceville, NJ (US)
Filed by Adare Pharmaceuticals USA, Inc., Lawrenceville, NJ (US)
Filed on Feb. 8, 2023, as Appl. No. 18/107,353.
Application 15/785,342 is a division of application No. 14/302,742, filed on Jun. 12, 2014, granted, now 9,814,678, issued on Nov. 14, 2017.
Application 18/107,353 is a continuation of application No. 16/542,405, filed on Aug. 16, 2019, granted, now 11,576,861.
Application 16/542,405 is a continuation of application No. 15/785,342, filed on Oct. 16, 2017, granted, now 10,398,649, issued on Sep. 3, 2019.
Application 14/302,742 is a continuation of application No. PCT/US2012/069287, filed on Dec. 12, 2012.
Claims priority of provisional application 61/569,655, filed on Dec. 12, 2011.
Prior Publication US 2023/0255889 A1, Aug. 17, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/14 (2006.01); A61K 9/16 (2006.01); A61K 31/09 (2006.01); A61K 31/192 (2006.01)
CPC A61K 9/145 (2013.01) [A61K 9/146 (2013.01); A61K 9/1611 (2013.01); A61K 9/1617 (2013.01); A61K 9/1652 (2013.01); A61K 31/09 (2013.01); A61K 31/192 (2013.01)] 29 Claims
OG exemplary drawing
 
1. A sustained-release solid dosage form comprising particles, each particle comprising:
an active ingredient present in an amount from 20% to about 60% by weight of the particles;
a hydrophobic matrix present in an amount from about 30% to about 80% by weight of the particles; and
an optional release modifier, that when present is in an amount from about 0.5% to about 25% by weight of the particles,
wherein the particles are substantially spherical and have a mean particle size diameter of from about 50 μm to about 500 μm and particle size distribution within a 10% standard deviation from the mean particle size diameter, and wherein the particles release from 62% to 80% of the active ingredient in 6 hours as measured by the USP II dissolution test.