Methods for treatment of attention deficit hyperactivity disorder

• US 9,889,095 B2
• Filed: 03/27/2017
• Issued: 02/13/2018
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Ironshore Pharmaceuticals & Development, Inc.
• Original Assignee: Ironshore Pharmaceuticals & Development, Inc.
• Inventors: Lickrish, David, Zhang, Feng
• Primary Examiner(s): Krass, Frederick
• Assistant Examiner(s): Cohen, Michael P
• Application Number:
  US15/470,705
• Publication Number:
  US 20170196817A1
• Time in Patent Office: 323 Days
• Field of Search: None
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/5015 Organic compounds, e.g. fats, sugars
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5042 Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077

Abstract

Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 8 hours or longer, followed by a prolonged release.

Claims

1. A method of treating a subject with a disorder or condition responsive to the administration of an amphetamine, comprising:

orally administering an effective amount of an amphetamine or a pharmaceutical salt thereof in a formulation comprising one or more water soluble capsules containing a unit dose of amphetamine or a pharmaceutical salt thereof in a solid dosage form that comprises a plurality of beads,

wherein said beads comprise a sustained release formulation comprising the amphetamine or a pharmaceutical salt thereof enclosed in a delayed release coating that is insoluble in an aqueous medium at pH below 5.5,

wherein the sustained release formulation comprises a drug-containing core enclosed in a sustained release coating comprising ethyl cellulose and hydroxypropyl cellulose in a ratio of about 1;

3 to 1;

5, dibutyl sebacate and from 25% to 50% magnesium stearate, and

wherein the method comprises administering the unit dose form 5-8 hours prior to the desired treatment period.

2. The method of claim 1, wherein the delayed release coating comprises methacrylic acid copolymer type-B, mono- and di-glycerides and polysorbate 80.

3. The method of claim 1, wherein administration of the formulation is timed to administer the drug prior to a subject'"'"'s bed time and to allow the subject to sleep during a period of absorption of less than 5% of the total therapeutic dose and to have absorbed a therapeutic level of drug at the anticipated time of awakening.

4. The method of claim 1, wherein the formulation is administered at night.

5. The method of claim 1, wherein the formulation is administered once a day.

6. The method of claim 1, wherein the formulation is administered more than once a day.

7. The method of claim 1, wherein the formulation is administered to a patient in a fasted state.

8. The method of claim 1, wherein the disorder or condition is attention deficit disorder, attention deficit hyperactivity disorder, excessive daytime sleepiness, major depressive disorder, bipolar depression, negative symptoms in schizophrenia, chronic fatigue, fatigue associated with chemotherapy or binge eating disorder.

9. The method of claim 1, wherein the disorder or condition is attention deficit disorder or attention deficit hyperactivity disorder.

10. The method of claim 1, wherein the disorder is binge eating disorder.