Patent ID: 11969434
Assignee: nan
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 27:
28. An oral pharmaceutical composition for use in treating a CNS disorder, said composition comprising about 3% to about 33% w/w of allopregnanolone, at least about 7% w/w of a hydrophilic additive, and at least about 0.9% w/w of a lipophilic additive,
wherein said hydrophilic additive has an HLB value of at least about 10, comprises about 7% to about 11% w/w of said composition, and 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 lipophilic additive has an HLB value of less than about 10, comprises about 0.9% to about 1.1% w/w of said composition, and 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 administration of said composition to a subject results in said subject:
a dose normalized minimum AUC0-24 of at least one of about 0.60 h/L, about 0.65 h/L, about 0.70 h/L, about 0.75 h/L, about 0.80 h/L, about 0.85 h/L, about 0.90 h/L, about 0.95 h/L, about 1.00 h/L, about 1.10 h/L, and about 1.20 h/L, and
a minimum AUC0-24 efficacy threshold of at least one of about 17 ng*h/mL, about 18 ng*h/mL, about 19 ng*h/mL, and about 20 ng*h/mL.