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Claims for Patent: 4,783,337

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Claims for Patent: 4,783,337

Title: Osmotic system comprising plurality of members for dispensing drug
Abstract:An osmotic system is disclosed comprising a wall comprising in at least a part of a semipermeable material that surrounds a compartment. The compartment contains a first osmotic composition comprising a beneficial drug selected from the group consisting of a calcium antagonist, angiotensin enzyme inhibitor and nonsteroidal antiinflammatory drugs, and a second and different osmotic composition. A passageway in the wall connects the first composition with the exterior of the system.
Inventor(s): Wong; Patrick S.-L. (Hayward, CA), Barclay; Brian L. (Sunnyvale, CA), Oeters; Joseph C. (Mountain View, CA), Theeuwes; Felix (Los Altos, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:06/912,712
Patent Claims: 1. An osmotic device for the oral administration at a controlled rate a beneficial angiotensin converting enzyme inhibitor to an enviromment of use, the osmotic device comprising:

(a) a wall comprising at least in part a composition permeable to the passage of an exterior fluid present in the environment of use, the wall surrounding and forming:

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising a dosage amount of an angiotensin converting enzyme inhibitor and an osmopolymer that exhibits an osmotic pressure gradient across the wall aganist an external aqueous fluid, which osmopolymer imbibes and absorbs aqueous fluid that enters the compartment to form a dispensable composition comprising the angiotension converting enzyme inhibitor;

(d) a second composition in the compartment, said second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and,

(e) at least one passageway in the wall connecting the exterior of the device with the interior of the device for delivering the composition comprising the angiotensin converting enzyme inhibitor from the osmotic device.

2. The osmotic device for the oral administration at a controlled rate the beneficial angiotensin converting enzyme inhibitor according to claim 1, wherein the second composition comprises an osmotically effective solute that exhibits an osmotic pressure gradient, across the semipermeable wall against an external fluid.

3. A method for administering a beneficial angiotensin converting enzyme inhibitor drug to a warm blooded animal, which method comprises:

(a) admitting an osmotic device orally into the animal, said osmotic device comprising:

(1) a shaped semipermeable wall comprising a composition permeable to the passage of an exterior fluid and substantially impermeable to the passage of the beneficial drug, the wall surrounding and forming:

(2) a compartment containing a first composition comprising a dosage unit amount of the beneficial angiotensin converting enzyme inhibitor and an osmopolymer that exhibits an osmotic gradient across the semipermeable wall against an external fluid, which osmopolymer imbibes aqueous fluid into the compartment and forms a dispensable composition comprising the angiotensin converting enyzme inhibitor, and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(3) at least one passageway in the wall connecting the exterior of the osmotic device with the first composition; and

(b) administering the beneficial angiotensin converting enzyme inhibitor to the animal by imbibing fluid through the semipermeable wall into the osmotic device to form a dispensable first composition comprising the angiotensin converting enzyme inhibitor, and by the second composition expanding, whereby the angiotensin converting enzyme inhibitor is administered by the combined actions of the first and second compositions through a passageway to the animal over time.

4. An osmotic device for orally administering a calcium antagonist drug to an environment of use, the osmotic device comprising:

(a) a wall permeable at least in part to the passage of fluid, which wall surrounds and forms,

(b) a compartment housing a first composition comprising a beneficial calcium antagonist drug and an osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid and imbibes fluid into the compartment to form a composition comprising the calcium antagonist drug, and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid; and

(c) a passageway in the wall communicating with the first composition and the exterior of the device for delivering the first composition comprising the beneficial calcium antagonist drug through the passageway to the environment of use from the device.

5. A method for managing the plasma levels in a patient on a calcium channel blocker drug, which method comprises administering orally a therapeuctically effective amount of a calcium channel blocker drug to a patient from an osmotic device, which device comprises: a semipermeable wall permeable at least in part to the passage of an exterior fluid and substantially impermeable to the passage of the calcium channel blocker drug, the wall surrounding and forming: a compartment comprising a first composition comprising a dosage amount of the calcium channel blocker drug and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid, and a second composition comprising a different osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid; at least one passageway in the wall communicating the exterior of the device with the first composition; and, delivering the composition comprising calcium channel blocker drug through a passageway to the patient for managing the plasma levels.

6. A dosage form for administering at a controlled rate a histamine receptor blocking drug to a warm blooded animal, which dosage form comprises:

(a) a wall comprising at least in part a composition permeable to the passage of an exterior fluid present in the environment of use an substantially impermeable to the passage of the histamine receptor blocking drug, the wall surrounding and forming:

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising a beneficial histamine receptor blocking drug and an osmoplolymer that exhibits an osmotic pressure gradient across the wall against an external fluid and forms a dispensable composition with fluid that enters the compartment;

(d) a second composition in the compartment, said second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and,

(e) at least one passageway in the wall communicating with the compartment and the exterior of the dosage form for delivering the composition comprising the beneficial histamine receptor blocking drug through the passageway from the dosage form.

7. The dosage form for administering at a controlled rate the histamine receptor blocking drug according to claim 6, wherein the passageway is a pore passageway.

8. The dosage form for administering at a controlled rate the histamine receptor blocking drug according to claim 6, wherein the second composition comprises an osmotically effective compound that exhibits an osmotic pressure gradient across the wall against a fluid.

9. An osmotic device for delivering at a controlled rate a beneficial agent to an enviromnent of use, the osmotic device comprising:

(a) a wall comprising in at least a part a semipermeable composition permeable to the passage of an exterior fluid present in the environment of use and substantially impermeable to the passage of a beneficial agent, which wall surrounds and forms:

(b) a compartment comprising (1) a first means for delivering a beneficial agent, said first means comprising a beneficial agent and an osmopolymer that forms a dispensable first means with fluid that enters the compartment; and, (2) a second means for assisting the first means for delivering the beneficial agent, said second means comprising an osmopolymer; and,

(c) a passageway in the wall communicating with the first means and the exterior of the device for delivering the first means comprising the beneficial agent from the device.

10. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the semipermeable composition comprises a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose ester, cellulose ether and cellulose ester ether.

11. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 9, wherein the first means is in the compartment as a layer, and the second means is in the composition as a layer.

12. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 9 wherein the first means imbibes external fluid through the wall into the compartment, and the second means imbibes external fluid.through the wall into the compartment.

13. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 9, wherein the osmopolymer comprising the second means has a molecular weight greater then the molecular weight of the osmopolymer comprising the first means.

14. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is theophylline.

15. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is salbutamol.

16. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is diazepam.

17. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is furosemide.

18. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is hydrochlorothiazide.

19. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is alpha-methyldopa.

20. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is isosorbide dinitrate.

21. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is indomethacin.

22. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is ibuprofen.

23. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is haloperidol.

24. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is a member selected from the group consisting of lisinopril, ramipril, enalapril, captopril and enalapriat.

25. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the beneficial agent is a member selected from the group consisting of famatidine, cimetidine, ranitidine, nizatidine, sucralfate and etintidine.

26. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the device comprises a plurality of passageways.

27. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the passageway is a microporous member.

28. The osmotic device for delivering at a controlled rate the beneficial agent according to claim 9, wherein the passageway comprises at least one pore.

29. A device for the controlled delivery of a beneficial drug to a biological enviromnent of use, comprising:

(a) a shaped wall that permits an exterior fluid present in the environment of use to enter the device, the wall surrounding and forming:

(b) a compartment comprising (1) a composition comprising a dosage amount of a drug, and a polymer that exhibits a gradient across the wall against an external fluid and forms a dispensable composition with fluid that enters the device, and (2) a composition comprising an osmotically effective compound that exhibits a gradient across the wall against external fluid, and a polymer that exhibits a gradient across the wall against an external fluid; and,

(c) a passageway in the wall communicating with the exterior of the device and the composition the drug for delivering a therapeutically effective amount of drug from the device at a controlled rate over a prolonged period of time.

30. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the device when in operation in the environment of use, the polymer present in composition (1) comprising the drug imbibes fluid through the wall into the compartment for hydrodynamically delivering the drug from the osmotic device.

31. The device for the controlled delivery of the beneficial drug ot the biological environment of use according to claim 29, wherein the device comprises more than one passageway.

32. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the passageway is a pore formed by leaching a leachable member from the wall.

33. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the passageway comprises at least one micropore in a wall comprising a cellulose acylate.

34. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the device when in operation in the environment of use, composition (2) comprising the osmotically effective compound and the polymer both imbibe fluid through the wall into the compartment.

35. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the shaped wall is formed of a polymeric composition selected from the group consisting of cellulose acetate butyrate and cellulose acetate propionate.

36. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the shaped wall is a laminate comprising a semipermeable lamina and a microporous lamina.

37. The device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 29, wherein the environment of use is the gastrointestinal tract and the shaped wall comprises a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacelate, cellulose acetate, cellulose diacetate, and cellulose triacetate.

38. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the biological environment of use is the vagina or the rectum.

39. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the biological environment is a human and the osmotic device is shaped and sized for oral admittance into the human.

40. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the device when in operation in the environment of use, (1) the composition comprising drug and the polymer imbibes fluid into the compartment and forms a dispensable formulation containing drug and polymer, and (2) the composition comprising osmotically effective compound and polymer imbibe fluid into the compartment and forms in situ a formulation containing compound and polymer, whereby through the combined operations of (1) and (2) the formulation containing drug is delivered through the passage way from the compartment to the exterior of the device over time.

41. The device for the controlled delivery of the beneficial drug according to claim 29, wherein polymer comprising composition (1) is water soluble.

42. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the polymer comprising composition (2) is water soluble.

43. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the beneficial drug is a member selected from the group consisting of mimodipine, nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamil, amlodipine and mioflazine.

44. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the beneficial drug is a nonsteroidal anti-inflammatory drug.

45. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the shaped wall is at least in part microporous.

46. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the shaped wall is microporous.

47. The device for the controlled delivery of the beneficial drug according to claim 29, wherein the beneficial drug is a polypeptide.

48. An device for the controlled delivery of a beneficial drug formulation to a biological environment of use, comprising:

(a) a shaped wall permeable in at least a part to the passage of an exterior biological fluid and substantially impermeable to the passage of drug formulation, which wall surrounds and forms:

(b) a compartment comprising: (1) a drug formulation that comprises a drug that is insoluble to very soluble in the biological fluid, an osmotically effective solute that is soluble in the exterior fluid and exhibits an osmotic pressure gradient across the wall against the fluid, and a polymer that imbibes fluid and absorb fluid that enters the compartment, which drug, solute and polymer form a dispensable formulation with fluid that enters the compartment; and, (2) a cooperating formulation that assists in delivering the drug formulation from the device, which cooperating formulation comprises an osmotically effective solute that is soluble in the exterior fluid and exhibits an osmotic pressure gradient across the wall against the fluid and a polymer that imbibes fluid and absorbs fluid that enters the compartment; and,

(c) a passageway in the semipermable wall connecting the exterior of the device with the interior of the device for delivering the drug formulation from the device to the environment at a controlled rate over prolonged period of time.

49. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the biological enviromnent of use is a human.

50. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the biological environment of use is the gastronitestinal tract, and the device is shaped and adapted for oral admittance therein.

51. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is verapamil.

52. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is diltiazem.

53. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is propanolol.

54. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is ibuprofen.

55. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is ketoprofen.

56. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is cephalexin.

57. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is a member selected from the group consisting of erythromycin, erthromycin lactobionate, erythromycin glucoheptonate and erythromycin estolate.

58. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is zomepirac.

59. The osmotic device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is a member selected from the group of cardiovascular drugs consisting of fendriline, perhexiline, gallopamil, prenylamine, captompril, bethamidine and atenolac.

60. The device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is flurobiprofen.

61. The device for the delivery of the beneficial drug formulation according to claim 48, wherein the drug is present as a therapeutically acceptable salt.

62. A dosage form for delivering at a controlled rate a beneficial drug to biological environment of use, the dosage form comprising:

(a) a wall comprising in at least a part a composition permeable to the passage of fluid, which wall surrounds and forms:

(b) a compartment comprising a beneficial drug formulation that exhibits an osmotic pressure gradient across the wall against an external biological fluid and forms a dispensable drug formulation with fluid that enters the compartment, and a composition comprising an osmotically effective compound that exhibits an osmotic pressure gradient across the wall against an external fluid for imbibing fluid into the compartment for occupying the compartment; and,

(c) a passageway in the wall communicating with the exterior of the dosage form and the compartment for delivering the drug formulation comprising a therapeutically effective amount of drug from the dosage form at a controlled rate over a prolonged period of time.

63. The dosage form for delivering at a controlled rate a beneficial drug to a biological environment of use according to claim 62, wherein the osmotically effective compound is a polymer.

64. The dosage form for delivering at a controlled rate the beneficial drug to a biological environment of use according to claim 62, wherein the osmotically effective compound is a solute.

65. An osmotic device for the delivery at a controlled rate a beneficial drug to a biological environment of use, the osmotic device comprising:

(a) a wall comprising in at least a part a semipermeable composition permeable to the passage of an exterior fluid present in the environment of use and substantially impermeable to the passage of beneficial drug, the wall surrounding and forming:

(b) a compartment comprising a beneficial drug formulation that forms a dispensable formulation with biological fluid that enters the osmotic device; and, a composition comprising an osmoticallly effective compound that exhibits an osmotic pressure gradient across the wall against an external fluid and a polymer that exhibits an osmotic pressure gradient across the wall aganist an external fluid; and,

(c) a passageway in the wall communicating with the exterior of the device and the dispensable formulation comprising the drug for delivering a therapeutically effective amount of drug from the device at a controlled rate over a prolonged period of time.

66. A composition for forming a drug delivery system, comprising: (1) a composition comprising a drug and an osmopolymer that forms with an aqueous fluid a composition dispensable from a drug delivery system; and (2) a composition in laminar arrangement with composition (1), which composition (2) comprises an osmagent and an osmopolymer, and wherein composition (1) and (2) exhibit an osmotic pressure gradient across a semipermeable polymer film against an aqueous fluid.

67. A method for administering a beneficial drug to the gastrointestinal tract of an animal, which method comprises:

(a) admitting an osmotic device orally into the animal, said osmotic device comprising:

(1) a wall comprising at least in part a semipermeable composition permeable to the passage of an exterior fluid and substantially impermeable to the passage of drug, which wall surrounds and forms:

(2) a compartment comprising a first composition comprising a dosage unit amount of a gastrointestinal administrable drug and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid, and a second composition comprising an osmopolymer that is a different osmopolymer and exhibits an osmotic pressure gradient across the wall against an external fluid;

(3) at least one osmotic passageway in the wall connecting the exterior of the osmotic device with the first composition; and,

(b) administering the drug by imbibing fluid through the wall into the first composition to form a dispensable first composition, and by imbibing fluid into the second composition to form a composition that expands against the first composition, whereby through the actions of the compositions the drug is urged through a passageway to the gastrointestinal tract over a prolonged period of time.

68. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is a member selected from the group consisting of milrinone, amrinone and digoxin.

69. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is an anterior pituitary suppressant.

70. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is a steroid.

71. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is an oral contraceptive.

72. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is danazol.

73. The method for administering a beneficial drug to the gastrointestinal tract of an animal according to claim 67, wherein the beneficial drug is diltiazem.

74. The method for administering a beneficial drug to the gastronitestinal tract of an animal according to claim 67, wherein the benficial drug is nicardipine.

75. The method for administering a beneficial drug to the gastronitestinal tract of an animal according to claim 67, wherein the wall of the osmotic device comprises in at least a part a layer comprising the beneficial drug on its outer surface.

76. An osmotic device for the administration of the beneficial drug diltiazem to an environment of use, the osmotic device comprising:

(a) a wall comprising in at least a part a composition pemerable to the passage of fluid, which wall surrounds and defines;

(b) a compartment;

(c) a first composition in the compartment, said composition comprising a dosage amount of diltiazem and a pharmaceutically acceptable polymer;

(d) a second composition in the compartment, said composition comprising an osmopolymer that expands in the presence of fluid; and,

(e) at least one passageway in the wall communicating with the compartment and the exterior of the device for delivering the first composition comprising the beneficial drug diltiazem to the envrionment of use over time.

77. The osmotic device for the administration of the beneficial drug diltiazem to the environment of use according to claim 76, wherein the wall of the osmotic device comprises in at least a part a layer comprising the beneficial drug diltiazem on its outer surface.

78. An osmotic device for the administration of the benficial drug nicardipine to an environment of use, the osmotic device comprising:

(a) a wall comprising in at least a part a nontoxic composition permeable to the passage of fluid, which wall surrounds and defines;

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising a dosage amount of the beneficial drug nicardipine and a pharmaceutically acceptable polymer;

(d) a second composition in the compartment, which composition comprises an osmopolymer that expands in the presence of fluid that enters the compartment; and,

(e) at least one passageway in the wall communicating with the composition comprising the beneficial drug nicardipine to the environment of use over time.

79. The osmotic device for the administration of the beneficial drug nicardipine to the environment of use according to claim 78, wherein the wall of the osmotic device comprises in at least a part a layer comprising the beneficial drug nicardipine on its outer surface.
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