OSMATIC DISPENSING DEVICE FOR RELEASING BENEFICIAL AGENT

• US 3,845,770 A
• Filed: 06/05/1972
• Issued: 11/05/1974
• Est. Priority Date: 06/05/1972
• 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:
  US05/259,469
• Time in Patent Office: 883 Days
• Field of Search: 128/260,130,272,269,127-129,213 99/77.1 424/15,37,19-21 222/386.5,389 206/.5
• US Class Current: 424/427
• 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 wall surrounding and forming a compartment for containing a useful composition of matter and having a passageway for dispensing the composition is disclosed. 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, said device comprising:

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

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

c. an osmotic passageway positioned in the imperforate wall and extending therethrough with the passageway communicating with the compartment and the exterior of the device, said passageway designed and sized for osmotically pumping the agent through the passageway from the device; and

d. wherein in operation with the device in the environment of use, the external fluid from such environment is continuously imbibed through the wall into the compartment in tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall thereby continuously dissolving the agent which in turn is then pumped under pressure from the device through the passageway at a controlled rate over a prolonged period of time.

2. An osmotic device for the continuous release of the agent according to claim 1 wherein the agent is a drug.

3. An osmotic device for the continuous release of the agent according to claim 2 wherein the agent is contained in the compartment along with an osmotically effective solute which in solution exhibits an osmotic pressure gradient against the external fluid.

4. An osmotic device for the continuous release of the agent according to claim 1 wherein the device is adapted for the release of the agent in the vagina.

5. An osmotic device for the continuous release of the agent according to claim 1 wherein the device is an oral device adapted for the release of the agent in the gastrointestinal tract.

6. An osmotic device for the continuous release of the agent according to claim 1 wherein the device is adapted for the release of the agent subcutaneously.

7. An osmotic device for the continuous release of the agent according to claim 1 wherein the device is adapted for the release of the agent in the uterus.

8. An osmotic device for the continuous release of the agent according to claim 1 wherein the wall of the device is comprised of an imperforate erodible material that is permeable to the passage of an external fluid and essentially impermeable to the passage of the agent, and wherein the material erodes in the environment of use after the dispensing period.

9. An osmotic device for the continuous dispensing of the agent according to claim 1 wherein the wall of the device is essentially insoluble in the external fluid.

10. An osmotic device for the continuous dispensing of the agent according to claim 1 wherein the device is shaped and adapted for the release of the agent in the mouth.

11. An osmotic ocular drug delivery device for the continuous and prolonged administration of an ophthalmic drug comprising:

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

b. a shaped wall formed of a substantially imperforate, semipermeable material that maintains its integrity during the dispensing period and which is characterized by being permeable to the passage of eye fluid in the environment of use and essentially impermeable to the passage of ophthalmic drug, with the wall surrounding and forming;

c. a compartment containing the ophthalmic drug that exhibits an osmotic pressure gradient across the wall against the eye fluid to internally pressurize the compartment in the environment of use;

d. an osmotic passageway positioned in the imperforate wall and extending therethrough with the passageway communicating with the compartment and the exterior of the device said passageway designed and sized for osmotically pumping the drug through the passageway from the device; and

e. wherein in the environment of use eye fluid is continuously imbibed through the wall into the compartment in tendency towards osmotic equilibrium at a rate proportional to the permeability of the wall and the osmotic pressure gradient across the wall thereby continuously dissolving the agent which in turn is then pumped under pressure from the device through the passageway at a controlled rate over a prolonged period of time from the device.

12. An osmotic device for the continuous dispensing of a beneficial agent, said device comprising;

a. a shaped wall formed of a material that maintains its integrity during the dispensing period, said wall comprised of an imperforate, semipermeable material that is permeable to the passage of an external fluid in the enivironment of use and substantially impermeable to the passage of the agent, with the wall surrounding and forming;

b. a compartment containing a mixture of an agent that has limited solubility in the fluid and an osmotically effective solute composition soluble in the fluid which exhibits an osmotic pressure gradient across the wall against the external fluid to internally pressurize the compartment in the environment of use;

c. an osmotic passageway positioned in the imperforate wall and extending therethrough with a passageway communicating with the compartment to the exterior of the device, said passageway designed and sized for osmotically pumping the agent through the passageway from the device; and

d. wherein in operation with the device in the environment of use, external fluid from such environment is continuously imbibed through the wall into the compartment in tendency towards osmotic equilibrium at a rate controlled by the permeability of the wall and the osmotic gradient across the wall thereby continuously dissolving the solute composition, which as a mixture with the agent is then in turn pumped from the device through the passageway at a controlled rate for a prolonged period of time.

13. A dispensing device for the continuous release of a product according to claim 12 wherein the agent is a drug.

14. An osmotic dispensing device for the continuous release of a beneficial agent according to claim 12 wherein the wall is formed in part of an imperforate material permeable to the passage of the fluid and impermeable to the passage of the agent and the remainder of the wall is formed of an imperforate material impermeable to the passage of both the fluid and the agent.

15. An osmotic device for the continuous dispensing of an active agent, said device comprising;

a. a shaped wall formed of a substantially pore-free semipermeable material which is characterized by being permeable to the passage of an external fluid in the environment of use and essentially impermeable to the passage of agent with the wall surrounding and forming;

b. a compartment containing means for producing pressure therein, said means being an active agent that is soluble in the external fluid, and which agent exhibits an osmotic pressure gradient across the wall against the external fluid to internally pressurize the compartment in the environmenT of use;

c. an osmotic passageway positioned in the wall and extending therethrough with the passageway communicating with the compartment and the exterior of the device, said passageway including means for maintaining said pressure in the compartment during the dispensing period; and

d. wherein in operation with the device in the environment of use, the external fluid from such environment is continuously imbibed through the wall into the compartment, in tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby continuously dissolving the agent which in turn is then pumped under pressure from the device through the passageway at a controlled rate over a prolonged period of time.