US5227167A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Long-term delivery device including hydrophobic loading dose
Assignee: Alza Corp
•
Filing: 1992-02-27
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Granted: 1993-07-13
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Expires: 2012-02-27
Abstract
Abstract The invention provides a dispensing device comprising a loading dose (first agent delivery means) for short-term and continuous delivery of an agent having a high potency, retained together with a long-term dispensing device (second agent delivery means) capable of a long-term and continuous delivery of agent. The combination of first and second agent delivery means provides a device in which a substantially constant dose of beneficial agent may be delivered to the environment of use over time. A rapid initial delivery of beneficial agent is followed by continuous and prolonged delivery of agent.
Inventors
- 👤 John P. Carr
- 👤 James B. Eckenhoff
- 👤 Terry L. Burkoth
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 23:22
CPC Classifications
A; A61; A61M; A61M31/00; A61M31/002; A61K; A61K9/00; A61K9/0002; A61K9/0004
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
305 words
A single dispensing device for delivering a beneficial agent having a high potency to an environment of use for a prolonged period of time, the dispensing device comprising: (a) a first agent delivery means for making a first beneficial agent formulation quickly and continuously available to the environment of use, the first agent delivery means comprising: (1) a first beneficial agent formulation which comprises at least one beneficial agent having a high potency, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first beneficial agent formulation releases the beneficial agent within the environment of use substantially throughout the time prior to the release of a second beneficial agent formulation; and (2) retaining means for retaining the first beneficial agent formulation at the surface of or within a second agent delivery means while exposing the first beneficial agent formulation and the second agent delivery means to the environment of use; and (b) a second agent delivery means for continuous and prolonged delivery of a second beneficial agent formulation to the environment of use, the second agent delivery means comprising: (1) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent in a second beneficial agent formulation; (2) a second beneficial agent formulation in the lumen that provides a dispensable formulation including at least one beneficial agent to the environment of use; (3) an expansion means in the lumen for displacing the second beneficial agent formulation from the interior of the lumen to the environment of use after exposure to the environment of use; and (4) an exit means for delivery of the second beneficial agent formulation to the environment of use.
Claim 2
Dependent Claim
305 words
A single dispensing device for delivering a beneficial agent having a high potency to an environment of use for a prolonged period of time, the dispensing device comprising: (a) a first agent delivery means for making a first beneficial agent formulation quickly and continuously available to the environment of use, the first agent delivery means comprising: (1) a first beneficial agent formulation which comprises at least one beneficial agent having a high potency, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first beneficial agent formulation releases the beneficial agent within the environment of use substantially throughout the time prior to the release of a second beneficial agent formulation; and (2) retaining means for retaining the first beneficial agent formulation at the surface of or within a second agent delivery means while exposing the first beneficial agent formulation and the second agent delivery means to the environment of use; and (b) a second agent delivery means for continuous and prolonged delivery of a second beneficial agent formulation to the environment of use, the second agent delivery means comprising: (1) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent in a second beneficial agent formulation; (2) a second beneficial agent formulation in the lumen that provides a dispensable formulation including at least one beneficial agent to the environment of use; (3) an expansion means in the lumen for displacing the second beneficial agent formulation from the interior of the lumen to the environment of use after exposure to the environment of use; and (4) an exit means for delivery of the second beneficial agent formulation to the environment of use.
Claim 3
Dependent Claim
37 words
A dispensing device according to claim 1 wherein the release rates of beneficial agent from the first and second delivery means are selected to maintain the total agent delivery rate substantially constant over the prolonged time period.
Claim 4
Dependent Claim
72 words
A dispensing device according to claim 1 wherein the release rates of beneficial agent from the first and second delivery means are selected to provide a first delivery rate of agent for an initial portion of the prolonged time period followed by a second delivery rate of agent, the second delivery rate being lower than the first delivery rate and being maintained substantially constant over the remainder of the prolonged time period.
Claim 5
Dependent Claim
23 words
A dispensing device according to claim 1 which further comprises density means for maintaining the device within the rumen of a ruminant animal.
Claim 6
Dependent Claim
18 words
A dispensing device according to claim 4 wherein the exit means comprises a passageway through the density means.
Claim 7
Dependent Claim
19 words
A dispensing device according to claim 1 wherein the first beneficial agent formulation is disposed within the exit means.
Claim 8
Dependent Claim
19 words
A dispensing device according to claim 5 wherein the first beneficial agent formulation is disposed within the exit means.
Claim 9
Dependent Claim
44 words
A dispensing device according to claim 1 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the environment of use and the first beneficial agent formulation.
Claim 10
Dependent Claim
24 words
A dispensing device according to claim 1 wherein the first beneficial agent formulation and the second beneficial agent formulation contain the same beneficial agent.
Claim 11
Dependent Claim
14 words
A dispensing device according to claim 9 wherein the beneficial agent is melengestrol acetate.
Claim 12
Dependent Claim
23 words
A dispensing device according to claim 1 wherein the first beneficial agent formulation and the second beneficial agent formulation contain different beneficial agents.
Claim 13
Dependent Claim
18 words
A dispensing device according to claim 1 wherein the first beneficial agent formulation is in a tablet form.
Claim 14
Dependent Claim
317 words
A single dispensing device for delivering melengestrol acetate to a ruminant animal for a prolonged period of time, the dispensing device comprising: (a) a first agent delivery means for making a first melengestrol acetate formulation quickly and continuously available to the rumen of the ruminant animal, the first agent delivery means comprising: (1) a first melengestrol acetate formulation which comprises melengestrol acetate, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first melengestrol acetate formulation releases the melengestrol acetate within the rumen environment substantially throughout the time prior to the release of a second melengestrol acetate formulation; and (2) retaining means for retaining the first melengestrol acetate formulation at the surface of or within a second agent delivery means while exposing the first melengestrol acetate formulation and the second agent delivery means to the rumen environment; and (b) a second agent delivery means for continuous and prolonged delivery of a second melengestrol acetate formulation to the rumen environment, the second agent delivery means comprising: (1) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of melengestrol acetate in a second melengestrol acetate formulation; (2) a second melengestrol acetate formulation in the lumen that provides a dispensable formulation of melengestrol acetate to the rumen environment; (3) an expansion means in the lumen for displacing the second melengestrol acetate formulation from the interior of the lumen to the rumen environment after exposure to the rumen environment; (4) density means for maintaining the device within the rumen; and (5) exit means for delivery of the second melengestrol acetate formulation to the rumen environment, where the exit means comprises a passageway through the density means and where the first melengestrol acetate formulation is disposed within the exit means.
Claim 15
Dependent Claim
317 words
A single dispensing device for delivering melengestrol acetate to a ruminant animal for a prolonged period of time, the dispensing device comprising: (a) a first agent delivery means for making a first melengestrol acetate formulation quickly and continuously available to the rumen of the ruminant animal, the first agent delivery means comprising: (1) a first melengestrol acetate formulation which comprises melengestrol acetate, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first melengestrol acetate formulation releases the melengestrol acetate within the rumen environment substantially throughout the time prior to the release of a second melengestrol acetate formulation; and (2) retaining means for retaining the first melengestrol acetate formulation at the surface of or within a second agent delivery means while exposing the first melengestrol acetate formulation and the second agent delivery means to the rumen environment; and (b) a second agent delivery means for continuous and prolonged delivery of a second melengestrol acetate formulation to the rumen environment, the second agent delivery means comprising: (1) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of melengestrol acetate in a second melengestrol acetate formulation; (2) a second melengestrol acetate formulation in the lumen that provides a dispensable formulation of melengestrol acetate to the rumen environment; (3) an expansion means in the lumen for displacing the second melengestrol acetate formulation from the interior of the lumen to the rumen environment after exposure to the rumen environment; (4) density means for maintaining the device within the rumen; and (5) exit means for delivery of the second melengestrol acetate formulation to the rumen environment, where the exit means comprises a passageway through the density means and where the first melengestrol acetate formulation is disposed within the exit means.
Claim 16
Dependent Claim
18 words
A dispensing device according to claim 13 wherein the first melengestrol acetate formulation is in a tablet form.
Claim 17
Dependent Claim
43 words
A dispensing device according to claim 13 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the rumen environment and the first melengestrol acetate formulation.
Claim 18
Dependent Claim
43 words
A dispensing device according to claim 14 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the rumen environment and the first melengestrol acetate formulation.
Claim 19
Dependent Claim
15 words
A dispensing device according to claim 13 wherein the carrier further comprises a hydrophilic material.
Claim 20
Dependent Claim
74 words
A dispensing device according to claim 13 wherein the release rates of melengestrol acetate from the first and second delivery means are selected to provide a first delivery rate of melengestrol acetate for an initial portion of the prolonged time period followed by a second delivery rate of melengestrol acetate, the second delivery rate being lower than the first delivery rate and being maintained substantially constant over the remainder of the prolonged time period.
Claim 21
Independent Claim
361 words
A method for administering a beneficial agent having a high potency to an environment of use for a prolonged period of time, which method comprises: (a) introducing into the environment of use a single dispensing device, which device comprises: (1) a first agent delivery means for making a first beneficial agent formulation quickly and continuously available to the environment of use, the first agent delivery means comprising: (i) a first beneficial agent formulation which comprises at least one beneficial agent having a high potency, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first beneficial agent formulation releases the beneficial agent within the environment of use substantially throughout the time prior to the release of a second beneficial agent formulation; and (ii) retaining means for retaining the first beneficial agent formulation at the surface of or within a second agent delivery means while exposing the first beneficial agent formulation and the second agent delivery means to the environment of use; and (2) a second agent delivery means for continuous and prolonged delivery of a second beneficial agent formulation to the environment of use, the second agent delivery means comprising: (i) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent in a second beneficial agent formulation; (ii) a second beneficial agent formulation in the lumen that provides a dispensable formulation including at least one beneficial agent to the environment of use; (iii) an expansion means in the lumen for displacing the second beneficial agent formulation from the interior of the lumen to the environment of use after exposure to the environment of use; and (iv) an exit means in the dispensing device for delivery of the second beneficial agent formulation to the environment of use; (b) releasing beneficial agent from the first agent delivery means for an initial portion of the prolonged period of time; and (c) releasing beneficial agent from the second agent delivery means for a terminal portion of the prolonged period of time.
Claim 22
Independent Claim
361 words
A method for administering a beneficial agent having a high potency to an environment of use for a prolonged period of time, which method comprises: (a) introducing into the environment of use a single dispensing device, which device comprises: (1) a first agent delivery means for making a first beneficial agent formulation quickly and continuously available to the environment of use, the first agent delivery means comprising: (i) a first beneficial agent formulation which comprises at least one beneficial agent having a high potency, in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first beneficial agent formulation releases the beneficial agent within the environment of use substantially throughout the time prior to the release of a second beneficial agent formulation; and (ii) retaining means for retaining the first beneficial agent formulation at the surface of or within a second agent delivery means while exposing the first beneficial agent formulation and the second agent delivery means to the environment of use; and (2) a second agent delivery means for continuous and prolonged delivery of a second beneficial agent formulation to the environment of use, the second agent delivery means comprising: (i) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent in a second beneficial agent formulation; (ii) a second beneficial agent formulation in the lumen that provides a dispensable formulation including at least one beneficial agent to the environment of use; (iii) an expansion means in the lumen for displacing the second beneficial agent formulation from the interior of the lumen to the environment of use after exposure to the environment of use; and (iv) an exit means in the dispensing device for delivery of the second beneficial agent formulation to the environment of use; (b) releasing beneficial agent from the first agent delivery means for an initial portion of the prolonged period of time; and (c) releasing beneficial agent from the second agent delivery means for a terminal portion of the prolonged period of time.
Claim 23
Dependent Claim
36 words
A method according to claim 19 wherein the release rates of agent from the first and second delivery means are selected to maintain the total agent delivery rate substantially constant over the prolonged period of time.
Claim 24
Dependent Claim
25 words
A method according to claim 19 wherein the dispensing device further comprises density means for maintaining the device within the rumen of a ruminant animal.
Claim 25
Dependent Claim
17 words
A method according to claim 21 wherein the exit means comprises a passageway through the density means.
Claim 26
Dependent Claim
18 words
A method according to claim 19 wherein the first beneficial agent formulation is disposed within the exit means.
Claim 27
Dependent Claim
43 words
A method according to claim 19 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the environment of use and the first beneficial agent formulation.
Claim 28
Dependent Claim
23 words
A method according to claim 19 wherein the first beneficial agent formulation and the second beneficial agent formulation contain the same beneficial agent.
Claim 29
Independent Claim
373 words
A method for administering melengestrol acetate to the rumen of a ruminant animal for a prolonged period of time, which method comprises: (a) introducing into the rumen of the animal a single dispensing device, which device comprises: (1) a first agent delivery means for making a first melengestrol acetate formulation quickly and continuously available to the rumen environment, the first agent delivery means comprising: (i) a first melengestrol acetate formulation which comprises melengestrol acetate in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first melengestrol acetate formulation releases the melengestrol acetate within the rumen environment substantially throughout the time prior to the release of a second melengestrol acetate formulation; and (ii) retaining means for retaining the first melengestrol acetate formulation at the surface of or within a second agent delivery means while exposing the first melengestrol acetate formulation and the second agent delivery means to the rumen environment; (2) a second agent delivery means for continuous and prolonged delivery of a second melengestrol acetate formulation to the rumen environment, the second agent delivery means comprising: (i) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of melengestrol acetate in a second melengestrol acetate formulation; (ii) a second melengestrol acetate formulation in the lumen that provides a dispensable formulation including melengestrol to the rumen environment; (iii) an expansion means in the lumen for displacing the second melengestrol acetate formulation from the interior of the lumen to the rumen environment after exposure to the rumen environment; (iv) density means for maintaining the device within the rumen environment; and (v) exit means in the dispensing device for delivery of the second melengestrol acetate formulation to the rumen environment, where the exit means comprises a passageway through the density means and where the first melengestrol acetate formulation is disposed within the exit means; (b) releasing melengestrol acetate from the first agent delivery means for an initial portion of the prolonged period of time; and (c) releasing melengestrol acetate from the second agent delivery means for a terminal portion of the prolonged period of time.
Claim 30
Independent Claim
373 words
A method for administering melengestrol acetate to the rumen of a ruminant animal for a prolonged period of time, which method comprises: (a) introducing into the rumen of the animal a single dispensing device, which device comprises: (1) a first agent delivery means for making a first melengestrol acetate formulation quickly and continuously available to the rumen environment, the first agent delivery means comprising: (i) a first melengestrol acetate formulation which comprises melengestrol acetate in a concentration of about 15 wt % or less, and a carrier comprising in at least a portion a hydrophobic material, which first melengestrol acetate formulation releases the melengestrol acetate within the rumen environment substantially throughout the time prior to the release of a second melengestrol acetate formulation; and (ii) retaining means for retaining the first melengestrol acetate formulation at the surface of or within a second agent delivery means while exposing the first melengestrol acetate formulation and the second agent delivery means to the rumen environment; (2) a second agent delivery means for continuous and prolonged delivery of a second melengestrol acetate formulation to the rumen environment, the second agent delivery means comprising: (i) a wall that surrounds and defines an internal lumen, the wall comprising a composition that is permeable to the passage of fluid and substantially impermeable to the passage of melengestrol acetate in a second melengestrol acetate formulation; (ii) a second melengestrol acetate formulation in the lumen that provides a dispensable formulation including melengestrol to the rumen environment; (iii) an expansion means in the lumen for displacing the second melengestrol acetate formulation from the interior of the lumen to the rumen environment after exposure to the rumen environment; (iv) density means for maintaining the device within the rumen environment; and (v) exit means in the dispensing device for delivery of the second melengestrol acetate formulation to the rumen environment, where the exit means comprises a passageway through the density means and where the first melengestrol acetate formulation is disposed within the exit means; (b) releasing melengestrol acetate from the first agent delivery means for an initial portion of the prolonged period of time; and (c) releasing melengestrol acetate from the second agent delivery means for a terminal portion of the prolonged period of time.
Claim 31
Dependent Claim
17 words
A method according to claim 26 wherein the first melengestrol acetate formulation is in a tablet form.
Claim 32
Dependent Claim
42 words
A method according to claim 26 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the rumen environment and the first melengestrol acetate formulation.
Claim 33
Dependent Claim
42 words
A method according to claim 27 wherein the retaining means comprises a member selected from the group consisting of a perforated plate, a screen, a porous membrane, and a perforated membrane disposed between the rumen environment and the first melengestrol acetate formulation.
Claim 34
Dependent Claim
73 words
A method according to claim 26 wherein the release rates of melengestrol acetate from the first and second delivery means are selected to provide a first delivery rate of melengestrol acetate for an initial portion of the prolonged time period followed by a second delivery rate of melengestrol acetate, the second delivery rate being lower than the first delivery rate and being maintained substantially constant over the remainder of the prolonged time period.
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