Drug delivery compositions and methods
First Claim
1. A method of preparing a composition useful as a system to introduce and transport medically useful compositions in the body of mammals;
- said composition comprising particles of a coacervate-based matrix having one or more physiologically-active compound incorporated therein and a coacervative-based encapsulating film surrounding each particle;
said method comprising forming a mixture of one or more surface active agents, water and one or more physiologically-active compounds to produce a two phase aqueous coacervate composition containing said compound, and emulsifying the composition to produce an aqueous emulsion of coacervate-based matrix particles containing the physiologically-active compound, said coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and said physiologically-active compound solubilized therein, said particles having an encapsulating coacervate-based film surrounding the particles.
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Accused Products
Abstract
Drug delivery compositions yeild new and unexpected degrees of stabilization, solubilization and delivery of incorporated medicaments, drugs, or other physiologically-active compounds. The compositions enable administration of drugs and other medically useful compounds via a variety of routes. More particularly, a drug delivery system or composition including one or more monomeric or polymerized surface active agents allows for rapid dissolution and smooth liberation of any desired incorporated drug or combinations, and the method of preparing the drug composition. In one embodiment, the physiologically-active compound is encapsulated by a coacervate-derived film, and the finished product is suitable for transmucosal administration. Other formulations of this invention may be administered via inhalation, oral, parenteral and by transdermal and transmucosal routes.
395 Citations
45 Claims
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1. A method of preparing a composition useful as a system to introduce and transport medically useful compositions in the body of mammals;
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said composition comprising particles of a coacervate-based matrix having one or more physiologically-active compound incorporated therein and a coacervative-based encapsulating film surrounding each particle; said method comprising forming a mixture of one or more surface active agents, water and one or more physiologically-active compounds to produce a two phase aqueous coacervate composition containing said compound, and emulsifying the composition to produce an aqueous emulsion of coacervate-based matrix particles containing the physiologically-active compound, said coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and said physiologically-active compound solubilized therein, said particles having an encapsulating coacervate-based film surrounding the particles. - View Dependent Claims (2, 3, 4)
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- 5. A method of preparing a composition containing one or more physiologically-active compounds for oral, inhalation, tissue absorptive or parenteral administration to a mammal comprising emulsifying an aqueous solution of water, a polymerized or polymerizable surface active agent, a coacervating agent and a physicologically-active compound to form an aqueous emulsion of coacervate-based matrix particles containing the physiologically-active compound solubilized therein, and bound in the coacervate matrix within a coacervate-based aqueous film containing the polymerized surface active agent wherein said coacervate matrix comprises water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and said physiologically-active compound solubilized therein.
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21. A method of introducing a physiologically-active compound into the circulatory system of a mammal comprising having the mammal orally ingest a composition comprising an aqueous coacervate system including water and a surface active agent, said coacervate system including an aqueous emulsion of coacervate-based matrix particles containing the compound solubilized therein;
- said aqueous coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and said physiologically-active compound solubilized therein.
- View Dependent Claims (22, 23, 24, 25, 26)
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27. A method of introduction a drug into the circulatory system of a mammal comprising having the mammal orally ingest a composition comprising an aqueous emulsion of coacervate-based matrix particles containing water, a surface active agent, and a drug solubilized therein;
- said coacervate system including a coacervate-based matrix containing the drug in aqueous solution; and
a coacervate-based film encapsulating the matrix particles, said aqueous coacervate-based matrix particles comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof and the drug. - View Dependent Claims (28, 29)
- said coacervate system including a coacervate-based matrix containing the drug in aqueous solution; and
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30. A method of introducing a drug into the circulatory system of a mammal comprising injecting the body of the mammal with a composition comprising an aqueous coacervate composition including water, a surface active agent, and a drug;
- said coacervate composition including a coacervate-based matrix containing the drug in aqueous solution or aqueous suspension and a film encapsulating the matrix particles;
said aqueous matrix particles containing water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and the drug solubilized or dispersed therein. - View Dependent Claims (31)
- said coacervate composition including a coacervate-based matrix containing the drug in aqueous solution or aqueous suspension and a film encapsulating the matrix particles;
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32. A method of preparing a composition containing one or more physiologically-active compounds for oral, tissue absorptive, inhalation, or parenteral administration to a mammal comprising mixing an aqueous solution of water, a surface active agent, a coacervating agent and a physiologically-active compound to form a two phase aqueous coacervate composition containing the physiologically-active compound in one or both of the two-phase bound as particles in a coacervate matrix and within a coacervate-based aqueous film containing the surface active agent, said coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof and the physiologically-active compound in solution within the matrix water;
- separating the particles; and
adding a hydrocolloid to the particles in an amount of 2-20% w/v to form a gel-like surface film surrounding the matrix particles containing the physiologically-active compound. - View Dependent Claims (33, 34, 35, 36, 37, 38)
- separating the particles; and
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39. A method of introducing a drug into the circulatory system of a mammal comprising having the mammal orally ingest a composition comprising an aqueous coacervate system including water, a surface active agent, and a drug;
- said coacervate system including a coacervate-based matrix containing the drug and a film encapsulating the matrix particles;
said aqueous coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, and the drug in solution within the matrix water;
separating the particles; and
adding a hydrocolloid to the particles in an amount of 2-20% w/v to form a gel-like surface film surrounding the matrix particles containing the drug. - View Dependent Claims (40, 41, 42)
- said coacervate system including a coacervate-based matrix containing the drug and a film encapsulating the matrix particles;
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43. A method of preparing a composition useful as a system to introduce and transport medically useful composition in the body of mammals;
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said composition comprising an aqueous emulsion of particles of a coacervate-based matrix having one or more physiologically-active compounds incorporated therein;
said coacervate-based matrix comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, said matrix particles including the physiologically-active compound solubilized in the matrix water;said method comprising forming a mixture of one or more surface active agents, water and one or more physiologically-active compounds to produce a two phase aqueous coacervate composition containing said compounds, and emulsifying the composition under conditions to produce an aqueous emulsion of the coacervate-based matrix particles containing the physiologically-active compound.
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44. A method of administering a physiologically-active compound to a mammal comprising topically applying a coacervate composition containing a physiologically-active compound on the skin of a mammal;
- said coacervate composition comprising an aqueous emulsion of coacervate-based matrix particles, said matrix particles comprising water, selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, said matrix particles including the physiologically-active compound solubilized in the matrix water; and
applying sound waves to the topically applied coacervate composition to drive the coacervate composition into the skin.
- said coacervate composition comprising an aqueous emulsion of coacervate-based matrix particles, said matrix particles comprising water, selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, said matrix particles including the physiologically-active compound solubilized in the matrix water; and
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45. A method of maintaining tissue or an organ of a mammal viable, outside of the mammal'"'"'s body comprising forming a mixture of one or more surface active agents and water to form a two phase aqueous coacervate composition, and emulsifying the composition to form an aqueous emulsion of coacervate-based matrix particles comprising water selected from the group consisting of coacervate phase water, equilibrium phase water, and mixtures thereof, said matrix particles having solubilized within the matrix water, a compound capable of extending the life of the organ when in contact therewith, and contacting the tissue or organ, outside of the mammal'"'"'s body, with said aqueous emulsion to maintain the visibility of the tissue or organ until said tissue organ is attached to a mammal.
Specification