Polyethylene oxide-based films and drug delivery systems made therefrom
First Claim
1. A rapid-dissolve film product comprising:
- at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, wherein said film product is free of added plasticizers.
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Abstract
The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.
191 Citations
36 Claims
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1. A rapid-dissolve film product comprising:
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at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, wherein said film product is free of added plasticizers. - 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)
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24. A rapid-dissolve film product comprising:
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at least one water-soluble polymer comprising PEO alone or in combination with a second polymer component, wherein said film is free of added plasticizers.
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25. A rapid-dissolve film product comprising:
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at least one water-soluble polymer comprising about 20% to 100% by weight polyethylene oxide, about 0% to 80% by weight hydroxypropylmethyl cellulose, and about 0% to 80% by weight hydroxypropyl cellulose;
an active component;
sucralose;
precipitated calcium carbonate;
at least one flavoring;
simethicone;
water; and
at least one colorant, wherein said film product is free of added plasticizers, surfactants, and polyalcohols.
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26. An edible water-soluble delivery system in the form of a film composition, comprising:
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at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a polymer selected from the group consisting of hydroxypropylmethyl cellulose and hydroxypropyl cellulose, wherein said edible water-soluble delivery system is essentially free of organic solvents, plasticizers, surfactants, and polyalcohols. - View Dependent Claims (27)
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28. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
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(a) combining at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, a solvent, and an active component to form a matrix with a uniform distribution of said components;
(b) forming a film from said matrix; and
(c) drying said film, wherein said film is free of added plasticizers. - View Dependent Claims (29, 30)
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31. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
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(a) combining at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, and an active component to form a matrix with a uniform distribution of said components; and
(b) extruding said matrix to form a film, wherein said film is free of added plasticizers. - View Dependent Claims (32)
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33. A rapid-dissolve, flexible film product being formed by the steps of:
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(a) combining at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, a solvent, and an active component to form a matrix with a uniform distribution of said components;
(b) forming a film from said matrix; and
(c) drying said film, wherein said film is free of added plasticizers.
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34. A premixture of a hydrophilic cellulosic polymer in a ratio of up to about 4:
- 1 with polyethylene oxide, which when deposited as a film and dried forms a rapid-dissolve delivery system for active components.
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35. A final film product comprising at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, which can be randomly divided and wherein no divided-out portion varies more than about 10% in composition of components.
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36. A final film product comprising at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer, which can be randomly divided and wherein no divided-out portion varies more than about 10% in active components.
Specification