Antidepressant dosage form

• US 8,084,059 B2
• Filed: 09/15/2006
• Issued: 12/27/2011
• Est. Priority Date: 05/27/1993
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Edgren, David Emil, Bhatti, Gurdish Kaur, Hatamkhani, Zahedeh, Wong, Patrick S. L.
• Primary Examiner(s): Arnold, Ernst
• Assistant Examiner(s): LEA, CHRISTOPHER RAYMOND
• Application Number:
  US11/522,014
• Publication Number:
  US 20070009600A1
• Time in Patent Office: 1,929 Days
• Field of Search: None
• US Class Current: 424/473
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine

Abstract

The invention pertains to a dosage form 10 and to administering an antidepressant medicament 16 for an extended period of time in a rate-known dose.

Claims

1. A dosage form having sustained-release or controlled-release properties for delivering 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol from the dosage form over an extended period of time in a therapeutically responsive dose to produce antidepressant therapy, the dosage form comprising:

(a) a wall comprising at least in part a composition permeable to the passage of fluid, but not to 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol, which wall surrounds;

(b) a compartment comprising a first layer and a second layer;

(c) a drug composition in the first layer of the compartment comprising 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol and a hydroxypropylalkylcellulose wherein said alkyl is of 1 to 7 carbons or a hydroxyalkylcellulose wherein said alkyl is of 1 to 6 carbons;

(d) a displacement composition in the second layer of the compartment comprising an osmotically active compound; and

(e) an exit passageway in the dosage form for delivering the drug composition from the dosage form.

2. The dosage form of claim 1, wherein said dosage form comprises a hydroxypropylalkylcellulose wherein said alkyl is of 1 to 7 carbons.

3. The dosage form of claim 1, wherein said hydroxypropylalkylcellulose comprises hydroxypropylmethylcellulose.

4. The dosage form of claim 1, wherein said hydroxyalkylcellulose is hydroxypropylcellulose.

5. The dosage form of claim 1, wherein the drug composition weighs about 25% more than the displacement composition.

6. The dosage form of claim 1, further comprising an external coat on the exterior of the wall that provides instant release of a drug for instant therapy, comprising a drug composition comprising 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl ]-cyclohexanol.

7. The dosage form of claim 1, wherein said extended period of time is at least 15 hours.

8. The dosage form of claim 1, wherein said extended period of time is at least 16 hours.

9. The dosage form of claim 1, wherein said extended period of time is at least 20 hours.

10. The dosage form of claim 1, wherein the osmotically active compound is selected from the group consisting of salts, oxides, esters, carbohydrates and acids.

11. The dosage form of claim 10 wherein said osmotically active compound is a salt selected from the group consisting of magnesium sulfate, magnesium chloride, sodium chloride, lithium chloride, potassium chloride, potassium sulfate, sodium sulfate, sodium sulfite, lithium sulfate, ammonium chloride, potassium lactate, magnesium succinate.

12. The dosage form of claim 11 wherein said salt is sodium chloride.

13. A dosage form having controlled-release properties for delivering 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol from the dosage form over an extended period of time in a therapeutically responsive dose to produce antidepressant therapy, the dosage form comprising:

(a) a wall comprising at least in part a composition permeable to the passage of fluid, but not to 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol, which wall surrounds;

(b) a compartment comprising a first layer and a second layer;

(c) a drug composition in the first layer of the compartment comprising 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol and poly(ethylene oxide);

(d) a displacement composition in the second layer of the compartment comprising an osmotically active compound and poly(ethylene oxide); and

(e) an exit passageway in the dosage form for delivering the drug composition from the dosage form.

14. The dosage form of claim 13, further comprising an external coat on the exterior of the wall that provides instant release of a drug for instant therapy, comprising a drug composition comprising 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl ]-cyclohexanol.

15. The dosage form of claim 13, wherein the osmotically active compound is selected from the group consisting of salts, oxides, esters, carbohydrates and acids.

16. The dosage form of claim 15 wherein said osmotically active compound is a salt selected from the group consisting of magnesium sulfate, magnesium chloride, sodium chloride, lithium chloride, potassium chloride, potassium sulfate, sodium sulfate, sodium sulfite, lithium sulfate, ammonium chloride, potassium lactate, magnesium succinate.

17. The dosage form of claim 16 wherein said salt is sodium chloride.

18. The dosage form of claim 13, wherein said extended period of time is at least 15 hours.

19. The dosage form of claim 13, wherein said extended period of time is at least 16 hours.

20. The dosage form of claim 13, wherein said extended period of time is at least 20 hours.

21. A dosage form having sustained-release or controlled-release properties for delivering 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol from the dosage form over an extended period of time in a therapeutically responsive dose to produce antidepressant therapy, the dosage form comprising:

(a) a wall comprising at least in part a composition permeable to the passage of fluid, but not to 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol, which wall surrounds;

(b) a compartment comprising a first layer and a second layer;

(c) a drug composition in the first layer of the compartment comprising 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol and a hydroxyalkylcellulose wherein said alkyl is of 1 to 6 carbons;

(d) a displacement composition in the second layer of the compartment comprising an osmotically active compound; and

(e) an exit passageway in the dosage form for delivering the drug composition from the dosage form.