Controlled release dispenser comprising beneficial agent
First Claim
1. A dispenser for delivering an ionophore at a controlled rate to a fluid environment of use, the dispenser comprising:
- (a) a wall comprising in at least a part a semipermeable composition permeable to the passage of fluid and substantially impermeable to the passage of the ionophore;
(b) a lumen surrounded by the wall;
(c) a composition in the lumen comprising ionophore and a pharmaceutically acceptable hydrophilic carrier for the ionophore;
(d) a hydrophilic polymeric driving member in the lumen that expands fluid for pushing the composition comprising the ionophore and the hydrophilic carrier from the dispenser;
(e) a densifier in the lumen; and
(f) an exit passageway or multiplicity of exit passageways in the wall for delivering a therapeutically effective amount of the ionophore from the dispenser at a controlled rate over a period of time, the diameter, of each exit passageway being of a size to maximize release of the ionophore by osmotic pumping and minimize release of the ionophore by diffusion or erosion to avoid mechanical agitation-dependent ionophore release.
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Accused Products
Abstract
A dispenser is disclosed for delivering a beneficial agent in a hydrophilic carrier formulation to an animal in a rate-controlled manner. The dispenser comprises (1) a semipermeable housing defining an internal space, (2) at least one composition comprising a beneficial agent and a pharmaceutically acceptable hydrophilic carrier in the space, (3) an expandable hydrophilic driving member in the space, (4) a density member in the space, and (5) one exit passageway or a multiplicity of exit passageways in the housing for delivering the beneficial agent from the dispenser, the diameter of each exit passageway being of a size to maximize release of the beneficial agent by osmotic pumping and to minimize release of the beneficial agent by diffusion or erosion to substantially avoid mechanical agitation-dependent release of the beneficial agent.
78 Citations
27 Claims
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1. A dispenser for delivering an ionophore at a controlled rate to a fluid environment of use, the dispenser comprising:
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(a) a wall comprising in at least a part a semipermeable composition permeable to the passage of fluid and substantially impermeable to the passage of the ionophore; (b) a lumen surrounded by the wall; (c) a composition in the lumen comprising ionophore and a pharmaceutically acceptable hydrophilic carrier for the ionophore; (d) a hydrophilic polymeric driving member in the lumen that expands fluid for pushing the composition comprising the ionophore and the hydrophilic carrier from the dispenser; (e) a densifier in the lumen; and (f) an exit passageway or multiplicity of exit passageways in the wall for delivering a therapeutically effective amount of the ionophore from the dispenser at a controlled rate over a period of time, the diameter, of each exit passageway being of a size to maximize release of the ionophore by osmotic pumping and minimize release of the ionophore by diffusion or erosion to avoid mechanical agitation-dependent ionophore release. - View Dependent Claims (6, 7, 12, 25)
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- 2. A dispenser according to claim 2 wherein the ionophore is lysocellin.
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8. A dispenser for delivering an ionophore at a controlled rate to a fluid environment of use, wherein the dispenser comprises:
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(a) a wall comprising in at least a part a nontoxic composition permeable to the passage of fluid and substantially impermeable to the passage of the ionophore; (b) a compartment surrounded and formed by the wall; (c) a first composition in the compartment comprising a ionophore and phnarmaceutically acceptable hydrophilic carrier for the ionophore; (d) a second composition in the compartment comprising a ionophore and a pharmaceutically acceptable hydrophilic carrier for the ionophore; (e) a hydrophilic polymeric driving member in the compartment comprising an osmotic composition that expands when contacted by fluid to displace the first and second compositions from the dispenser; (f) a densifier in the compartment; and (g) an exit passageway or multiplicity of exit passageways in the wall for delivering the first and second ionophore compositions from the dispenser at a controlled rate in therapeutically effective amounts over a period of time, the diameter of each exit passageway being of a size to maximize release of the ionophore by osmotic pumping and minimize release of the ionophore by diffusion or erosion to avoid mechanical agitation-dependent ionophore release. - View Dependent Claims (9, 10, 11, 13, 14, 15, 16, 17, 18, 19, 26)
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20. A composition for dispensing an ionophore from a drug delivery dispenser to livestock over a prolonged period of time, said composition comprising 10 mg to 100 g of an ionophore selected from the group consisting of valinomycin, enniactin, monactin, nonactin, dinactin, trinactin, virginiamycin, tetronasin, semduramicin, monensin, monensin sodium, nigericin, narasin, salinomycin, isolasalocid, lasalocid, lysocellin, septamycin, laidlomycin, laidlomycin propionate, laidlomycin butyrate, lonomycin, lenotemycin, grisorixin, alborixin, erythromycin, azoiomycin and sodium lysocellin, and pharmaceutically acceptable salts and esters thereof;
- and a pharmaceutically acceptable poly(ethylene oxide) carrier comprising a 200,000 to 7,500,000 molecular weight.
- View Dependent Claims (21, 23)
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22. A method for administering to an animal an ionophore at a controlled rate, said method comprising:
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(A) admitting orally into the animal a dispenser comprising; (1) a wall that surrounds and forms an internal lumen, the wall comprising in at least a part a composition permeable to the passage of fluid and substantially impermeable to the passage of an ionophore; (2) a composition in the lumen comprising an ionophore selected from the group consisting of valinomycin, enniactin, monactin, nonactin, dinactin, trinactin, virginiamycin, tetronasin, semduramicin, monensin, monensin sodium, nigericin, narasin, salinomycin, isolasalocid, lasalocid, lysocellin, septamycin, laidlomycin, laidlomycin propionate, laidlomycin butyrate, lonomycin, lenotemycin, grisorixin, alborixin, erythromycin, azolomycin and sodium lysocellin, and pharmaceutically acceptable salts and esters thereof; and
a pharmaceutically acceptable hydrophilic carrier for the ionophore, said carrier comprising a poly(ethylene oxide) comprising up to 90 wt % of the ionophore;(3) a hydrophilic driving member in the lumen that expands when contacted by fluid, thereby exerting pressure against the ionophore composition for displacement of the ionophore composition from the lumen; (4) a densifier in the lumen for maintaining the dispenser in the animal over time; and (5) an exit passageway or multiplicity of exit passageways in the wall for delivering the ionophore from the dispenser, the diameter of each exit passageway being of a size to maximize release of the ionophore by osmotic pumping and to minimize release of the ionophore by diffusion or erosion to avoid mechanical agitation-dependent ionophore release; and (B) administering the ionophore by the ionophore composition absorbing fluid to form a dispensable composition and by the hydrophilic driving member absorbing fluid, expanding and displacing the ionophore composition through the passageway or passageways in a therapeutically effective amount to the animal at a controlled rate over time. - View Dependent Claims (24, 27)
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Specification