	US 12,409,185 B1
	Oral allopregnanolone compositions and methods of use
Jonathan Ogle, Salt Lake City, UT (US); Benjamin J. Bruno, Salt Lake City, UT (US); Kongnara Papangkorn, Salt Lake City, UT (US); Samuel Akapo, Salt Lake City, UT (US); Joel Frank, Salt Lake City, UT (US); Nachiappan Chidambaram, Salt Lake City, UT (US); and Mahesh V. Patel, Salt Lake City, UT (US)
Filed by Lipocine Inc., Salt Lake City, UT (US)
Filed on Oct. 7, 2024, as Appl. No. 18/908,278.
Application 18/908,278 is a continuation of application No. 17/937,934, filed on Oct. 4, 2022.
Application 17/937,934 is a continuation in part of application No. 17/823,080, filed on Aug. 29, 2022, granted, now 11,969,434, issued on Apr. 30, 2024.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/57 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61P 25/24 (2006.01)

CPC A61K 31/57 (2013.01) [A61K 9/0053 (2013.01); A61K 9/20 (2013.01); A61K 9/48 (2013.01); A61P 25/24 (2018.01)]

30 Claims

1. A method of treating a PPD in a subject, said method comprising orally administering to said subject a tablet form oral pharmaceutical composition (PC) and fat containing food,

wherein said subject comprises at least one of an adolescent human female, and an adult human female, and

wherein said PC comprises allopregnanolone in an amount of from about 200 mg to about 300 mg, and

wherein said administration comprises a dosing regimen, said dosing regimen comprising a plurality of doses, and

wherein said regimen comprises a minimum daily dosing of three doses, and

wherein said dose comprises at least two tablet forms, and

wherein said regimen comprises a minimum daily allopregnanolone administration of from about 1400 mg to about 1600 mg, and

wherein said regimen comprises a minimum duration of at least one of 48 hours, and

wherein said administration of said PC to said subject results in a C_maxof at least 10 ng/mL of allopregnanolone in said subject.