Osmotic dispensing device with maximum and minimum sizes for the passageway

• US 3,916,899 A
• Filed: 02/07/1974
• Issued: 11/04/1975
• Est. Priority Date: 04/25/1973
• Status: Expired due to Term

• Current Assignee: Felix Theeuwes, Takeru Higuchi
• Original Assignee: Felix Theeuwes, Takeru Higuchi
• Inventors: Theeuwes, Felix, Higuchi, Takeru
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): McGowan, J. C.
• Application Number:
  US05/440,281
• Time in Patent Office: 635 Days
• Field of Search: 128/127-130,213,260,261,269 99/77.1 424/15,19-21,37 222/386.5,389 206/.5
• US Class Current: 424/424
• CPC Class Codes: A61F 6/144 with T-configuration
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A device is disclosed comprised of a wall surrounding and forming a compartment for containing a useful composition of matter and having a passageway for dispensing the compostion. The wall is comprised in at least a part of a material permeable to an external fluid. The composition is soluble in the fluid and exhibits an osmotic pressure gradient against the fluid or the composition has limited solubility and is admixed with an osmotically effective compound soluble in the fluid that exhibits an osmotic pressure gradient against the fluid. In operation composition is dispensed from the device by fluid permeating into the compartment producing a solution of the soluble composition or a solution of the osmotically effective compound containing the composition, which solution in either operation is released through the passageway to the exterior of the device at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall of the device.

Claims

1. An osmotic device for the continuous dispensing of an active agent to an environment of use, said device comprising:

a. a shaped wall formed of a semipermeable material that maintains its integrity during the dispensing period and which is characterized as permeable to the passage of an external fluid in the environment of use and substantially impermeable to the passage of the active agent, the wall surrounding and forming;

b. a compartment containing the active agent that is soluble in the external fluid, and which agent exhibits an osmotic pressure gradient across the wall against the external fluid;

c. a passageway in the wall for dispensing agent from the device, said passageway having a maximum cross-sectional area, As, defined aS

2. a compartment containing the active agent that Is soluble in fluid that enters the compartment and which agent exhibits an osmotic pressure gradient across the wall against the gastrointestinal fluid;

3. The osmotic device according to claim 1 wherein the agent in the compartment is mixed with an organic or inorganic solute that exhibits an osmotic pressure gradient against the external environmental fluid.

4. The osmotic device according to claim 1 wherein the device is structured and adapted to be placed in the vagina.

5. The osmotic device according to claim 1 wherein the device is structured and adapted in the form of a subcutaneous implant.

6. The osmotic device according to claim 1 wherein the device is an intrauterine device adapted for the release of agent to the uterus.

7. The osmotic device according to claim 1 wherein the wall material of the device is selected from the group consisting of cellulose acetate, methyl cellulose, polyvinyl alcohol and polyurethane.

8. The osmotic device according to claim 1 wherein said device has a single passageway.

9. The osmotic device according to claim 1 wherein the compartment additionally contains a dispersant for the agent.

10. The osmotic device according to claim 1 wherein the compartment additionally contains a gelling agent.

11. The osmotic device according to claim 1 wherein the compartment contains the agent and the solute admixed in a binder that releases the agent and solute on contact with external fluid that enters the compartment.

12. A device for the continuous dispensing of an active agent, said device comprising;

a. a shaped wall formed in part of a semipermeable material that is permeable to the passage of an external fluid in the environment of use and substantially impermeable to the agent, and in the remaining part of a material substantially impermeable to both the fluid and agent;

b. a compartment defined by the wall and containing the agent that exhibits an osmotic pressure gradient across the wall against the fluid;

c. a passageway communicating with the compartment and the exterior of the device, said passageway having a maximum cross-sectional area As, defined by

13. A device for the continuous dispensing of an agent according to claim 12 wherein the agent is contained in the compartment along with an organic or inorganic solute that exhibits an osmotic pressure gradient across the wall against the external fluid.

14. A device for the continuous dispensing of an agent according to claim 12 wherein the wall material of the device is comprised of a material that erodes after the device releases its agent in the environment of use.

15. A device for the continuous dispensing of an active agent according to claim 14 wherein the material is a member selected from the group consisting of polyglycolic and polylactic acid.

16. A device for the continuous dispensing of an agent according to claim 12 wherein the device is comprised of a material that is substantially insoluble in water.

17. A device for the continuous dispensing of an agent according to claim 12 wherein the device is adapted and structured for the release of the agent in the mouth.

18. A device for the continuous dispensing of an agent according to claim 12 wherein the agent dispensed from the device to the environment of use is a member selected from the group consisting of pesticide, insecticide, germicide, fungicide and algicide.

19. A device for the continuous dispensing of an agent according to claim 12 wherein the agent dispensed from the device to the environment of use is a plant nutrient.

20. An ocular device for the continuous and prolonged administration of an ophthalmic drug, said device comprising:

a. an ophthalmic drug that exhibits an osmotic pressure gradient against eye fluid;

b. a wall formed of a semipermeable material that is insoluble in eye fluid and which material is permeable to the passage of eye fluid and essentially impermeable to the passage of drug, the wall forming a compartment containing the drug;

c. a passageway in the wall and extended therethrough so as to communicate with the compartment and the exterior of the device, said passageway having a maximum cross-sectional area, As defined by

21. An ocular device for the continuous and prolonged administration of a drug according to claim 20 wherein the drug is a member selected from the group consisting of pilocarpine and its pharmaceutically acceptable salts.

22. An osmotic device for the continuous dispensing of an active agent to an environment of use, said device comprising:

a. a shaped wall formed of a semipermeable material that maintains its integrity during the dispensing period and which is characterized as permeable to the passage of an external fluid in the environment of use and substantially impermeable to the passage of the active agent, the wall surrounding and forming;

b. a compartment containing a mixture of the active agent, characterized by having limited solubility in the external fluid, and an osmotically effective solute composition which exhibits an osmotic pressure gradient across the wall against the external fluid;

c. a passageway in the wall for dispensing agent from the device, said passageway having a maximum cross-sectional area, As, defined as

23. An osmotic device for the continuous dispensing of an agent according to claim 22 wherein the agent is a drug.

24. An osmotic device for the continuous dispensing of an agent according to claim 22 wherein the agent is a member selected from the group consisting of biocide, insecticide and fungicide.

25. An osmotic device for the continuous dispensing of an agent according to claim 22 wherein the agent is a plant fertilizer.

26. The osmotic device according to claim 22 wherein the compartment additionally contains a dispersant for the agent.

27. The osmotic device according to claim 22 wherein the compartment additionally contains a gelling agent.

28. The osmotic device according to claim 22 wherein the compartment contains the agent and the solute admixed in a binder that releases the agent and solute on contact with external fluid that enters the compartment.

29. An oRal device for the controlled and continuous dispensing of a unit dosage amount of drug, to the gastrointestinal tract, said device comprising:

a. a shaped wall formed of an inert, nontoxic material that maintains its integrity during the dispensing period of drug, said wall comprised of a semipermeable material that is permeable to the passage of an external gastrointestinal fluid and substantially impermeable to drug, with the wall surrounding and forming;

b. a compartment containing the unit dosage amount of drug, said drug being soluble in the external fluid, with drug exhibiting an osmotic pressure gradient across the wall against the fluid when the device is in the environment of use;

c. a passageway communicating with the compartment and the exterior of the device for dispensing drug from the device, said passageway adapted to pass a therapeutically effective amount of drug and having a maximum cross-sectional area, As defined by

30. The oral device according to claim 29 wherein the drug in the compartment is mixed with an organic or inorganic solute that exhibits an osmotic pressure gradient against the gastrointestinal fluids.

31. The oral device according to claim 29 wherein the compartment additionally contains a member selected from the group consisting of a colloid, a dispersant, a binder, a gelling agent, and a surfactant for the drug.

32. The oral device according to claim 29 wherein the drug is a member selected from the group consisting of acetazolamide, potassium chloride, quinine dihydrochloride, sodium salicylate, diphenyl hydantoin, 1-dopa, codeine, scopolamine, benzodiazepine, chlordiazepoxide, ephedrine, procainamide, nitroglycerin, 5-fluorouracil, insulin, tolbutamide, chlorpropamide, and chlorpromazine.

33. The oral device according to claim 29 wherein the drug in the compartment is present in a form selected from the group consisting of a dispersion, tablet, solution, paste, cream, granule, emulsion, suspension and powder.

34. The oral device according to claim 29 wherein the wall is a member selected from the group consisting of cellulose acetate, methyl cellulose, polyvinyl alcohol and polyurethane.

35. A method for continuously administering an active agent at a controlled rate to the gastrointestinal tract of a warm blooded animal comprising:

A. Admitting into the gastrointestinal tract a device comprising;

36. The oral device according to claim 29 wherein the drug is potassium chloride.