Oral Brexanolone Compositions and Methods of Preparation and Use
AssigneeLipocine Inc.
InventorsNachiappan Chidambaram, Mahesh V. Patel, Jonathan Ogle, Kongnara Papangkorn, Samuel Akapo, Joel Frank, Benjamin J. Bruno
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Abstract
Disclosed is a method and a brexanolone containing oral composition for treating CNS disorders such as depression. An embodiment of the invention comprises orally administering a brexanolone containing composition to a subject having a CNS disorder. The composition and methods disclosed herein exhibit effective oral absorption/bioavailability and a predetermined ratio of bioavailability in a fed state administration relative to a fasted state administration.
Claims30
A method for use in treating depression comprising administering a treatment regimen to a subject having depression,
- wherein said regimen comprises administering a dose of at least one of at least one solid dosage form, at least two solid dosage forms, at least three solid dosage forms, and at least four solid dosage forms, and
- wherein said at least one solid dosage form comprises brexanolone, and
- wherein said at least one solid dosage form comprises at least one solid dosage form of at least about 10 mg, at least about 15 mg, at least about 20 mg, at least about 25 mg, at least about 30 mg, at least about 35 mg, at least about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 110 mg, at least about 120 mg, at least about 130 mg, at least about 140 mg, at least about 150 mg, at least about 160 mg, at least about 170 mg, at least about 180 mg, at least about 190 mg, at least about 200 mg, at least about 225 mg, at least about 250 mg, at least about 300 mg, at least about 350 mg, at least about 400 mg, at least about 450 mg, at least about 500 mg, at least about 550 mg, at least about 600 mg, at least about 700 mg, at least about 800 mg, at least about 900 mg, at least about 1000 mg, at least about 1100 mg, and at least about 1200 mg, and
- wherein said regimen comprises a dosing interval frequency of at least one of about one hour, about two hours, about three hours, about four hours, about six hours, about eight hours, about twelve hours, and about 24 hours, and
- wherein said regimen comprises a minimum duration of at least one of 1 day, 2 days, 2.5 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 12 days, 14 days, 16 days, 18 days, 20 days, 21 days, 22 days, 24 days, 26 days, 28 days, 30 days, and more than 30 days.
A method for use in treating depression comprising administering to a subject having depression a pharmaceutical composition (PC) comprising brexanolone or a prodrug thereof (brex-P) and at least one additive (BPC) with fat containing food, wherein said food comprises at least one of:
- about 600 to about 1000 calories wherein about 20% to about 35% thereof comprises fat,
- about 600 to about 1000 calories wherein at least about 20% thereof comprises fat,
- about 800 to about 1000 calories wherein about 40% to about 60% thereof comprises fat, and
- about 800 to about 1000 calories wherein at least about 50% thereof comprises fat.
A method for use in treating depression comprising administering to a subject having depression at least one solid dosage form PC comprising brex-P and at least one additive (BPC), wherein said administration comprises at least one of:
- at least one solid dosage form comprising at least about 400 mg,
- one solid dosage form comprising about 500 mg,
- a plurality of solid dosage forms, each of said plurality of solid dosage forms comprising at least about 200 mg, and
- a plurality of solid dosage forms, each of said plurality of solid dosage forms comprising about 250 mg.
A method for use in treating MDD comprising administering to a subject having MDD at least one solid dosage form PC comprising brexanolone or a prodrug thereof (brex-P) and at least one additive (BPC) with a fat containing food,
- wherein said food comprises about 600 to about 1000 calories wherein at least about 20% thereof comprises fat, and
- wherein said at least one solid dosage form comprises at least one of:
- at least one solid dosage form comprising at least about 400 mg,
- one solid dosage form comprising about 500 mg,
- a plurality of solid dosage forms, each of said plurality of solid dosage forms comprising at least about 200 mg, and
- a plurality of solid dosage forms, each of said plurality of solid dosage forms comprising about 250 mg.
Dependencies are inferred from the claim text.