US4014334A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Laminated osmotic system for dispensing beneficial agent
Assignee: Alza Corp
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Filing: 1976-02-02
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Granted: 1977-03-29
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Expires: 1996-02-02
Abstract
Abstract An osmotic system for delivering a beneficial agent to an environment of use is disclosed. The system comprises a laminate surrounding a compartment and has a passageway through the laminate for releasing agent from the compartment. The laminate comprises at least two laminae; one consisting of a semipermeable, polymeric material that is permeable to the passage of an external fluid and maintains its physical and chemical integrity in the environment of use, and one consisting of a semipermeable polymeric material that is permeable to the passage of the fluid, substantially impermeable to the passage of agent and maintains its physical and chemical integrity in the presence of agent. The compartment comprises an active agent that is either soluble in the external fluid and exhibits an osmotic pressure gradient across the laminate against the fluid, or the agent has limited solubility in the fluid and it is mixed with an osmotically effective compound that is soluble in the fluid and exhibits an osmotic pressure gradient across the laminate against the fluid. In operation, agent is released from the system by fluid being imbibed through the laminate into the compartment at a rate controlled by the permeability of the laminate and the osmotic pressure gradient across the laminate producing a solution containing agent, or a solution of compound containing agent which solution in either operation is released through the passageway at a controlled and continuous rate over a prolonged period of time.
Inventors
- 👤 Felix Theeuwes
- 👤 Atul D. Ayer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 16:40
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0002; A61K9/0004; A61F; A61F9/00; A61F9/0008; A61F9/0017
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
202 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped wall comprising a laminate, said laminate comprising a semipermeable lamina that is permeable to the passage of an external fluid and which lamina substantially maintains its physical and chemical integrity in the environment of use; and a semipermeable lamina that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and which lamina substantially maintains its physical and chemical integrity in the presence of fluid and agent, said wall surrounding; b. a compartment containing the beneficial agent; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the wall into the 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 continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 2
Dependent Claim
202 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped wall comprising a laminate, said laminate comprising a semipermeable lamina that is permeable to the passage of an external fluid and which lamina substantially maintains its physical and chemical integrity in the environment of use; and a semipermeable lamina that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and which lamina substantially maintains its physical and chemical integrity in the presence of fluid and agent, said wall surrounding; b. a compartment containing the beneficial agent; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the wall into the 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 continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 3
Dependent Claim
26 words
The osmotic system according to claim 1 wherein the laminae are formed of a member selected from the group consisting of semipermeable homopolymer and copolymer materials.
Claim 4
Dependent Claim
30 words
The osmotic system according to claim 1 wherein each lamina consists essentially of a unit lamina forming material with the laminae in laminar relation to form an integral laminated wall.
Claim 5
Dependent Claim
24 words
The osmotic system according to claim 1 wherein the lamina that maintains its integrity in the presence of fluid and agent faces the compartment.
Claim 6
Dependent Claim
32 words
The osmotic system according to claim 1 wherein the lamina that maintains its integrity in the environment of use is distant from the compartment and is formed of a hydrophilic semipermeable polymer.
Claim 7
Dependent Claim
27 words
The osmotic system according to claim 1 wherein the system is sized, shaped and adapted as a dosage form for administering an agent to the gastrointestinal tract.
Claim 8
Dependent Claim
17 words
The osmotic system according to claim 1 wherein the passageway is formed in the environment of use.
Claim 9
Dependent Claim
24 words
The osmotic system according to claim 1 wherein the agent is a member selected from the group consisting of locally and systemically acting drugs.
Claim 10
Dependent Claim
36 words
The osmotic system according to claim 1 wherein the beneficial agent is a member selected from the group consisting of acetazolamide, methazolamide, potassium chloride, ascorbic acid, niacin, meprobamate, salicylamide, theophylline monoethanolamine, aminophylline, procainamide, colchicine and atropine.
Claim 11
Dependent Claim
28 words
The osmotic system according to claim 1 wherein the beneficial agent is soluble in the fluid and exhibits an osmotic pressure gradient across the wall against the fluid.
Claim 12
Dependent Claim
36 words
The osmotic system according to claim 1 wherein the beneficial agent is mixed with an osmotically effective compound that is soluble in the fluid and exhibits an osmotic pressure gradient across the wall against the fluid.
Claim 13
Dependent Claim
222 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped laminate that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent, said laminate comprising a pair of laminae, with one lamina consisting of a semipermeable material that is essentially non-erodible and exhibits substantial inertness to compounds and fluids present in the environment of use, and with one lamina consisting of a semipermeable material that is essentially non-erodible and exhibits substantial inertness to fluid and agent; b. the laminate surrounding and forming a compartment containing the beneficial agent that is soluble in the fluid and exhibits an osmotic pressure gradient across the laminate against the fluid; c. a passageway in the laminate communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminate into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminate and the osmotic pressure gradient across the laminate, thereby continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 14
Dependent Claim
222 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped laminate that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent, said laminate comprising a pair of laminae, with one lamina consisting of a semipermeable material that is essentially non-erodible and exhibits substantial inertness to compounds and fluids present in the environment of use, and with one lamina consisting of a semipermeable material that is essentially non-erodible and exhibits substantial inertness to fluid and agent; b. the laminate surrounding and forming a compartment containing the beneficial agent that is soluble in the fluid and exhibits an osmotic pressure gradient across the laminate against the fluid; c. a passageway in the laminate communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminate into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminate and the osmotic pressure gradient across the laminate, thereby continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 15
Dependent Claim
25 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein each lamina is formed of a different polysaccharide.
Claim 16
Dependent Claim
39 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein each lamina is formed of a different cellulose ester having a degree of substitution greater than 0 and up to 3 inclusive.
Claim 17
Dependent Claim
40 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein each lamina is independently selected from the group consisting of cellulose acylates, cellulose diacylates, cellulose triacylates, cellulose acetate, cellulose diacetate and cellulose triacetate.
Claim 18
Dependent Claim
29 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the system is sized, shaped and adapted for placement in a vagina.
Claim 19
Dependent Claim
29 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the system is sized, shaped and adapted for placement in an eye.
Claim 20
Dependent Claim
44 words
The osmmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the agent is a member selected from the group consisting of idoxuridine, phenylephrine, pilocarpine, pilocarpine salts, eserine, carbachol, phospholine idodine, demecarium bromide, cyclopentolate, homatropine, scopolamine and epinephrine.
Claim 21
Dependent Claim
35 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the lamina that maintains its integrity in the environment of use is impermeable to the passage of agent.
Claim 22
Dependent Claim
39 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the lamina that maintains its integrity in the environment of use is impermeable to the passage of compounds present in the environment.
Claim 23
Dependent Claim
29 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the lamina inert to agent is impermeable to the passage of agent.
Claim 24
Dependent Claim
30 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 12 wherein the lamina inert to agent is impermeable to compounds present in the environment.
Claim 25
Dependent Claim
226 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped laminate comprising two laminae, with one lamina consisting of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to compounds present in the environment of use, and substantially maintains its physical and chemical integrity in the environment of use, and with one lamina consisting of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and compounds present in the environment of use, and substantially maintains its physical and chemical integrity in the presence of fluid and agent; b. the laminate surrounding and forming a compartment containing the agent; c. a passageway in the laminate communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminate into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminate and the osmotic pressure gradient across the laminate, thereby forming a solution containing agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 26
Dependent Claim
226 words
An osmotic system for the controlled and continuous dispensing of a beneficial agent to an environment of use, said system comprising: a. a shaped laminate comprising two laminae, with one lamina consisting of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to compounds present in the environment of use, and substantially maintains its physical and chemical integrity in the environment of use, and with one lamina consisting of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and compounds present in the environment of use, and substantially maintains its physical and chemical integrity in the presence of fluid and agent; b. the laminate surrounding and forming a compartment containing the agent; c. a passageway in the laminate communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminate into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminate and the osmotic pressure gradient across the laminate, thereby forming a solution containing agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 27
Dependent Claim
30 words
The osmotic system according to claim 23 wherein the agent is a drug soluble in the external fluid and exhibits an osmotic pressure gradient across the laminate against the fluid.
Claim 28
Dependent Claim
36 words
The osmotic system according to claim 23 wherein the agent has limited solubility in the fluid and is mixed with an osmotically effective compound that exhibits an osmotic pressure gradient across the laminate against the fluid.
Claim 29
Dependent Claim
47 words
The osmotic system according to claim 23 wherein the lamina that is substantially impermeable to agent is the interior surface of the laminate positioned adjacent to the compartment and is formed of a unit, semipermeable material selected from the group consisting of cellulose esters and cellulose ethers.
Claim 30
Dependent Claim
66 words
The osmotic system according to claim 23 wherein the lamina that maintains its integrity in the environment of use is the exterior surface of the laminate positioned distant from the compartment and is formed of a unit, semipermeable material selected from the group consisting of cellulose esters and cellulose ethers possessing different physical and chemical properties from the material forming the interior surface of the laminate.
Claim 31
Dependent Claim
29 words
The osmotic system according to claim 23 wherein the agent is a member selected from the group consisting of tolbutamide, tolazamide, chloropropamide, mannitol, hexanitrate, tranylcypromine, progestational and estrogenic agents.
Claim 32
Dependent Claim
27 words
The osmotic system according to claim 23 wherein the compartment contains an osmotically effective compound that exhibits an osmotic pressure of from 0 up to 500 atmospheres.
Claim 33
Dependent Claim
22 words
The osmotic system according to claim 23 wherein the passageway is formed before the system is placed in the environment of use.
Claim 34
Dependent Claim
28 words
The osmotic system according to claim 23 wherein the lamina that substantially maintains its integrity in the environment of use is substantially impermeable to the passage of agent.
Claim 35
Dependent Claim
44 words
The osmotic system according to claim 23 wherein the lamina that substantially maintains its integrity in the environment of use is substantially impermeable to the passage of compounds present in the environment of use to agents and osmotically effective compounds present in the compartment.
Claim 36
Dependent Claim
191 words
An osmotic system for the controlled and continuous dispensing of an active agent to an environment of use, said system comprising: a. a compartment containing an active agent; b. a shaped laminated wall surrounding and forming the compartment, said wall formed of a plurality of semipermeable laminae comprising a lamina positioned adjacent to the compartment that maintains its physical and chemical integrity in the presence of agent, and a lamina positioned distant from the compartment that faces the environment and maintains its physical and chemical integrity when the system is in the environment; c. a passageway in the laminated wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminated wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminated wall and the osmotic pressure gradient across the wall, thereby continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 37
Dependent Claim
191 words
An osmotic system for the controlled and continuous dispensing of an active agent to an environment of use, said system comprising: a. a compartment containing an active agent; b. a shaped laminated wall surrounding and forming the compartment, said wall formed of a plurality of semipermeable laminae comprising a lamina positioned adjacent to the compartment that maintains its physical and chemical integrity in the presence of agent, and a lamina positioned distant from the compartment that faces the environment and maintains its physical and chemical integrity when the system is in the environment; c. a passageway in the laminated wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is in the environment of use, fluid from the environment is continuously imbibed through the laminated wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the laminated wall and the osmotic pressure gradient across the wall, thereby continuously dissolving agent that is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.
Claim 38
Dependent Claim
35 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 33 wherein the laminae are formed of a member selected from the group consisting of homopolymeric and copolymeric semipermeable materials.
Claim 39
Dependent Claim
49 words
The osmotic system for the controlled and continuous dispensing of an agent according to claim 33 wherein the laminae are permeable to the passage of an external fluid, substantially impermeable to compounds present in the environment of use and substantially impermeable to agents and compounds present in the compartment.
Claim 40
Dependent Claim
40 words
The osmotic system for the controlled and continuous dispensing of an active agent according to claim 33 wherein the laminae are formed of a different material selected from the group consisting of hydrophilic and hydrophobic homopolymeric and copolymeric semipermeable materials.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1980-03-28 | 1980-09-27 | 1981-03-29 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1984-03-28 | 1984-09-27 | 1985-03-29 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1988-03-28 | 1988-09-27 | 1989-03-29 | $7700.00 | Window Closed / Lapsed |