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Claims for Patent: 4,612,008

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Claims for Patent: 4,612,008

Title: Osmotic device with dual thermodynamic activity
Abstract:An osmotic system is disclosed comprising a wall formed in at least a part of a semipermeable material that surrounds a compartment. The compartment contains a first osmotic composition comprising a beneficial agent, 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 (Sunnyvale, CA), Deters; Joseph C. (Mt. View, CA), Theeuwes; Felix (Los Altos, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:06/685,092
Patent Claims: 1. An osmotic device for the delivery at a controlled rate a beneficial agent to an 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 a beneficial agent, the wall surrounding and forming:

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising a beneficial agent, an osmagent that exhibits an osmotic pressure gradient across the wall against an external fluid, and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid;

(d) a second composition in the compartment, said second composition comprising an osmagent that exhibits an osmotic pressure gradient across the wall against an external fluid, and 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 first composition and the exterior of the device for delivering the beneficial agent through the passageway from the device.

2. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the semipermeable composition is a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate and cellulose triacetate.

3. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the beneficial agent is a member selected from the group consisting essentially of algicide, germicide, herbicide, fungicide, insecticide and pesticide.

4. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the first composition is in the compartment as a layer, and the second composition is in the compartment as a layer.

5. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the first composition imbibes external fluid through the wall into the compartment, and the second composition imbibes external fluid through the wall into the compartment.

6. The osmotic device for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the osmopolymer comprising the second composition has a molecular weight greater than the molecular weight of the osmopolymer comprising the first composition.

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

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

(b) a compartment comprising: (1) a composition comprising a dosage amount of a drug, an osmotically 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 against an external fluid, and (2) a composition comprising an osmotically 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 against an external fluid; and,

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

8. The osmotic device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 7, wherein the device when in operation in the environment of use, the osmotically effective compound present in composition (1) comprising the drug imbibes fluid through the wall into the compartment and the polymer present in said composition (1) imbibes fluid through the wall into the compartment for osmotically delivering the drug from the osmotic device.

9. The osmotic device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 7, wherein the device when in operation in the environment of use, composition (2) comprising the osmotically effective compound and the polymer imbibes fluid through the wall into the compartment.

10. The osmotic device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 7, wherein the shaped wall is formed of a semipermeable material, selected from the group consisting of cellulose acylate, cellulose diacylate, and cellulose triacylate.

11. The osmotic device for the controlled delivery of the beneficial drug to the biological environment of use according to claim 7, wherein the shaped wall is a laminate comprising a semipermeable lamina and a microporous lamina.

12. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the device when in operation in the environment of use, (1) the composition comprising drug, osmotically effective compound and polymer imbibes fluid into the compartment and forms a formulation containing drug, compound and polymer, and (2) the composition comprising osmotically effective compound and polymer imbibes 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 passageway from the compartment to the exterior of the osmotic device over time.

13. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the polymer comprising composition (1) is water soluble.

14. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the polymer comprising composition (1) is cross linked.

15. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the polymer comprising composition (2) is water soluble.

16. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the polymer comprising composition (2) is cross linked.

17. An osmotic 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, which formulation 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 absorbs fluid that enters the compartment; and (2) a delivery formulation, which 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) at least one passageway in the wall connecting the exterior of the device with the drug formulation for delivering the drug formulation from the device to the environment at a controlled rate over a prolonged period of time.

18. The osmotic device for the delivery of the beneficial drug formulation according to claim 7, wherein the biological environment of use is a human.

19. The osmotic device for the delivery of the beneficial drug formulation according to claim 7, wherein the biological environment of use is the gastrointestinal tract, and the device is shaped and adapted for oral admittance therein.

20. A composition of matter useful for forming a drug delivery system, the composition comprising in combination: (1) a first composition comprising a drug, an osmagent and an osmopolymer; and, (2) a second composition in laminar arrangement with the first composition (1), which second composition (2) comprises an osmagent and an osmopolymer, and wherein compositions (1) and (2) exhibit an osmotic pressure gradient across a semipermeable polymeric film against fluid selected from the group consisting essentially of aqueous and biological fluids.

21. The osmotic device for the delivery at a controlled rate the beneficial agent to the environment of use according to claim 1, wherein the passageway is formed in the environment of use.

22. The osmotic device for the delivery at a controlled rate the beneficial agent to an environment of use according to claim 1, wherein the wall comprises in at least a part a microporous composition comprising a pore former that is removed during the operation of the device providing at least one passageway.

23. The osmotic device for the delivery of a beneficial drug to a biological environment of use according to claim 7, wherein the passageway is formed in the environment of use.

24. The osmotic device for the controlled delivery of a beneficial drug to a biological environment of use according to claim 7, wherein the wall comprises in at least a part a microporous composition comprising a pore former that is removed during operation of the device.

25. The osmotic device for the controlled delivery of a beneficial drug to a biological environment of use according to claim 7, wherein the wall comprises in at least a part a microporous composition comprising the pore former sorbitol that is removed from the wall during operation of the device.

26. An osmotic device for the controlled delivery of a beneficial drug formulation to a biological environment of use according to claim 17, wherein the passageway in the wall is formed in the environment of use.

27. An osmotic device for the controlled delivery of a beneficial drug formulation to a biological environment of use according to claim 17, wherein the wall comprises in at least a part a microporous composition comprising a pore former that is a member selected from the group consisting of sucrose, glucose, fructose, mannitol, mannose, galactose, aldohexose, altrose, talose, sorbitol, and lactose that is removed from the wall in the environment of use providing a passageway in the wall.
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