	US 12,186,327 B2
	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. 4, 2022, as Appl. No. 17/937,934.
Application 17/937,934 is a continuation in part of application No. 17/823,080, filed on Aug. 29, 2022.
Prior Publication US 2024/0173335 A1, May 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)]

42 Claims

1. A method of treating a CNS disorder in a human subject, said CNS disorder comprising at least one of a sleep disorder, a mood disorder, PND, PPD, postpartum psychosis, essential tremors, treatment resistant depression, perinatal depression, dysthymic disorder, bipolar disorder, GAD, social anxiety disorder, stress, PTSD, OCD, schizophrenia, schizoaffective disorder, epilepsy, SE, seizures, ADHD, dementia, Huntington's disease, Parkinson's disease, anti-social personality disorder, OCD, autism, synaptopathy, Rett syndrome, Fragile X syndrome, Angelman syndrome, neuropathic pain, an injury related pain syndrome, acute pain, chronic pain, TBI, stroke, ischemia, a vascular malformation, a substance abuse disorder, a withdrawal syndrome, and tinnitus,

wherein said method comprises the step of orally administering to said subject an encapsulated or solid dosage form oral pharmaceutical composition comprising at least about 3% w/w of allopregnanolone, at least one hydrophilic additive, and at least one lipophilic additive, and

wherein said at least one hydrophilic additive comprises at least one of polysorbate 80, polyoxyl 40 hydrogenated castor oil, sodium lauryl sulfate, sodium docusate, polyethylene glycol 1000 tocopherol succinate, PEG 400, and a poloxamer, and

wherein said at least one lipophilic additive comprises at least one of glyceryl monocaprylate, glyceryl monocaprylocaprate, α-tocopherol, sterol, a sterol derivative, stearic acid, a glyceride of coconut oil, and a sorbitan fatty acid ester, and

wherein said administration of said composition to said subject results in at least one of:

a C_maxof at least 10 ng/ml of allopregnanolone in said subject, and

an effective dose of at least 10 mg of allopregnanolone in said subject.