Osmotic device for dispensing two different medications

• US 4,455,143 A
• Filed: 03/22/1982
• Issued: 06/19/1984
• Est. Priority Date: 03/22/1982
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Barclay, Brian, Theeuwes, Felix, Cortese, Richard
• Primary Examiner(s): Padgett, Benjamin R.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/360,396
• Time in Patent Office: 820 Days
• Field of Search: 604/890-900, 424/19-25
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic device is disclosed for delivering two beneficial drugs to an environment of use. The device comprises a semipermeable wall surrounding a lumen divided into a first compartment containing a drug that is separated from a second compartment containing a different drug. An orifice through the wall communicates with the first compartment for delivering drug from the first compartment, and another orifice through the wall communicates with the second compartment for delivering drug from the second compartment. In operation, drug is dispensed separately from each compartment by fluid being imbibed through the wall into each compartment at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall against the drug in each compartment thereby producing in each compartment a solution containing drug that is dispensed through their orifices at a controlled and continuous rate over a prolonged period of time.

Claims

1. An osmotic therapeutic device for the controlled delivery of beneficial drugs to a biological environment, the device consisting essentially of:

(a) a wall formed of a semipermeable material permeable to the passage of an external fluid present in the environment and substantially impermeable to the passage of drug, the semipermeable wall surrounding and forming;

(b) a first compartment containing a drug formulation that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(c) a second compartment containing a drug formulation that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(d) a partition positioned between the first and second compartments, which partition is formed of a material selected from the group consisting essentially of semipermeable, microporous and impermeable materials;

(e) a first orifice in the wall communicating with the first compartment and the exterior of the device for delivering drug formulation from the first compartment to the environment over a prolonged period of time; and

,

(f) a second orifice in the wall communicating with the second compartment and the exterior of the device for delivering drug formulation from the second compartment to the environment over a prolonged period of time.

2. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein when the device is in operation in the environment of use, fluid from the environment is imbibed through the wall into (1) the first compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby forming a solution containing drug that is delivered through the first orifice from the device at a controlled rate over a prolonged period of time, and into (2) the second compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby forming a solution containing drug that is delivered through the second orifice from the device at a controlled rate over a prolonged period of time.

3. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug formulation in the first compartment comprises a dosage unit amount of drug and an osmagent.

4. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug formulation in the second compartment comprises a dosage unit amount of drug and an osmagent.

5. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the first and second compartments contain different drugs.

6. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the device is adapted for oral administration for delivering drugs to the gastrointestional tract.

7. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a bronchodilator and the drug in the second compartment is a vasodilator.

8. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is a diuretic.

9. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is a vasodilator.

10. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1 wherein the drug in the first compartment is a beta-agonist and the drug in the second compartment is a muscle relaxant.

11. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a beta-adrenergic agonist and the drug in the second compartment is a histamine receptor antagonist.

12. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is an anti-hypertensive.

13. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a beta-adrenergic stimulator and the drug in the second compartment is a muscle relaxant.

14. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is an antihypertensive and the drug in the second compartment is a diuretic.

15. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is an antispasmodic and the drug in the second compartment is an anticholenergic.

16. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is an anticholinergic and the drug in the second compartment is a histamine receptor antagonist.

17. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the drug in the first compartment is a tranquilizer and the drug in the second compartment is an anticholinergic.

18. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 1, wherein the wall surrounding the first compartment is formed of a different material and thickness than the wall surrounding the second compartment.

19. An osmotic therapeutic device for the controlled delivery of beneficial drugs to a biological environment, the device consisting essentially of:

(a) a laminated wall formed of a semipermeable lamina in laminar arrangement with a microporous lamina, the laminated wall surrounding and forming;

(b) a first compartment containing a drug formulation that exhibits an osmotic pressure gradient across the laminated wall against an external fluid;

(c) a second compartment containing a drug formulation that exhibits an osmotic pressure gradient across the laminated wall against an external fluid;

(d) a partition positioned between the first compartment and the second compartment, which partition is formed of a material selected from the group consisting essentially of semipermeable, microporous, and impermeable materials;

(e) a first orifice in the laminated wall communicating with the first compartment and the exterior of the device for delivering drug formulation from the first compartment to the environment over a prolonged period of time; and

,

(f) a second orifice in the laminated wall communicating with the second compartment and the exterior of the device for delivering drug formulation from the second compartment to the environment over a prolonged period of time.

20. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein when the device is in operation in the environment of use, fluid from the environment is imbibed through the laminated wall into (1) the first compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby forming a solution containing drug that is delivered through the first orifice from the device at a controlled rate over a prolonged period of time, and into (2) the second compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby forming a solution containing drug that is delivered through the second orifice from the device at a controlled rate over a prolonged period of time.

21. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the drug formulation in the first compartment comprises a dosage unit amount of drug and an osmagent.

22. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the drug formulation in the second compartment comprises a dosage unit amount of drug and an osmagent.

23. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the first and second compartments contain different drugs.

24. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the device is adapted for oral administration for delivering drugs to the gastrointestional tract.

25. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the semipermeable lamina faces the compartments and the microporous lamina faces the environment.

26. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the microporous lamina faces the compartments and the semipermeable lamina faces the environment.

27. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a bronchodilator and the drug in the second compartment is a vasodilator.

28. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is a diuretic.

29. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is a vasodilator.

30. The osmotic therapeutic device for the controlled delivery of the beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-agonist and the drug in the second compartment is a muscle relaxant.

31. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-adrenergic agonist and the drug in the second compartment is a histamine receptor antagonist.

32. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-blocker and the drug in the second compartment is an anti-hypertensive.

33. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is a beta-adrenergic stimulator and the drug in the second compartment is a muscle relaxant.

34. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is an antihypertensive and the drug in the second compartment is a diuretic.

35. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the drug in the first compartment is an antispasmotic and the drug in the second compartment is an anticholenergic.

36. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19, wherein the drug in the first compartment is an anticholinergic and the drug in the second compartment is a histamine receptor antagonist.

37. The osmotic therapeutic device for the controlled delivery of beneficial drug according to claim 19, wherein the drug in the first compartment is a tranquilizer and the drug in the second compartment is an anticholinergic.

38. The osmotic therapeutic device for the controlled delivery of beneficial drugs according to claim 19 wherein the wall surrounding the first compartment is formed of a different material and thickness than the wall surrounding the second compartment.