Multi-layered osmotic device
First Claim
1. An improved A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
- a) a compressed core comprising a first active agent and an osmotic agent for controlled and continuous release of the drug first active agent;
b) a semipermeable membrane surrounding the core and having a preformed passageway therein, said semipermeable membrane being permeable to a fluid in the environment of use and substantially impermeable to the first active agent;
c) an inert, completely erodible or water soluble polymer coat comprising poly(vinylpyrrolidone)-(vinyl acetate) copolymer partially or substantially completely surrounding the semipermeable membrane and plugging the passageway in the wall semipermeable membrane; and
d) an external coat comprising a second active agent for immediate release of the drug second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use to provide a controlled delivery of the one or more active agents.
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Accused Products
Abstract
The present invention provides a simple and improved multi-layered osmotic device (1) that is capable of delivering a first active agent in an outer lamina (2) to one environment of use and a second active agent in the core (5) to another environment of use. Particular embodiments of the invention provide osmotic devices in which the first and second active agents are similar or dissimilar. An erodible polymer coat (3) between an internal semipermeable membrane (4) and a second active agent-containing external coat (2) comprises poly(vinylpyrrolidone)-(vinyl acetate) copolymer. This particular erodible polymer results in an improved multi-layered osmotic device possessing advantages over related devices known in the art. The active agent in the core (5) is delivered through a pore (6) containing an erodible plug (7). The osmotic device (1) can be coated by a final finish coat (8).
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Citations
54 Claims
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1. An improved A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and an osmotic agent for controlled and continuous release of the drug first active agent;
b) a semipermeable membrane surrounding the core and having a preformed passageway therein, said semipermeable membrane being permeable to a fluid in the environment of use and substantially impermeable to the first active agent;
c) an inert, completely erodible or water soluble polymer coat comprising poly(vinylpyrrolidone)-(vinyl acetate) copolymer partially or substantially completely surrounding the semipermeable membrane and plugging the passageway in the wall semipermeable membrane; and
d) an external coat comprising a second active agent for immediate release of the drug second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use to provide a controlled delivery of the one or more active agents. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 34, 35, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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24. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and an osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having a preformed passageway therein, said semipermeable membrane being permeable to a fluid in the environment of use and substantially impermeable to the first active agent;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the passageway in the semipermeable membrane; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for immediate release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use to provide a controlled delivery of the one or more active agents. - View Dependent Claims (28, 29, 30, 31, 32, 33)
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25. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the passageway in the semipermeable membrane; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for immediate release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use.
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26. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the at least one preformed passageway in the semipermeable membrane; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use.
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27. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the at least one preformed passageway in the semipermeable membrane; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for immediate, rapid, delayed, slow, sustained, pseudo-first order, pseudo-zero order, timed, controlled or combination thereof release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use.
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36. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the passageway in the semipermeable membrane and comprising poly(vinylpyrrolidone)-(vinyl acetate) copolymer and a second polymer; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for immediate release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use. - View Dependent Claims (37, 38)
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49. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the at least one preformed passageway in the semipermeable membrane, wherein the inert, completely erodible or water soluble polymer coat comprises poly(vinylpyrrolidone)-(vinyl acetate) copolymer; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use. - View Dependent Claims (50, 51)
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52. A multi-layered osmotic device for the controlled delivery of one or more active agents to one or more environments of use wherein the osmotic device comprises:
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a) a compressed core comprising a first active agent and at least one osmotic agent for controlled and continuous release of the first active agent;
b) a semipermeable membrane surrounding the core and having at least one preformed passageway therein;
c) an inert, completely erodible or water soluble polymer coat partially or completely surrounding the semipermeable membrane and plugging the at least one preformed passageway in the semipermeable membrane and comprising poly(vinylpyrrolidone)-(vinyl acetate) copolymer; and
d) an external coat applied to and covering the inert polymer coat and comprising a second active agent for immediate, rapid, delayed, slow, sustained, pseudo-first order, pseudo-zero order, timed, controlled or combination thereof release of the second active agent, wherein the first active agent is released from the core after the polymer coat has partially or completely dissolved or eroded, and the first and second active agents are released into the same or different environments of use. - View Dependent Claims (53, 54)
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Specification