Bioadhesive hot-melt extruded film for topical and mucosal adhesion applications and drug delivery and process for preparation thereof
First Claim
1. A hot-melt extruded composition comprising:
- about 30-95% wt. of one or more water-soluble or water-swellable thermoplastic polymers;
about 1-25% wt. of polycarbophil;
about 1-60% wt. of poly(ethylene oxide);
about 0.1-10% wt. of an organic acid;
about 0.01-10% wt. of an antioxidant; and
about 0-50% wt. of a therapeutic agent;
wherein the composition has been hot-melt extruded without extensive degradation in the absence of a plasticizer.
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Abstract
The present invention includes a hot-melt extruded film and method of preparation thereof. The film is made from a precursor composition containing at least a water soluble or water swellable thermoplastic polymer, preferably HPC and/or PEO, and a bioadhesive polymer. The film can also contain a therapeutic agent, preservative, buffering agent, antioxidant, super-disintegrant or absorbent, flavorant, colorant, water insoluble polymer, organic acid, surfactant, film modifier, and/or cross-linking agent. The film does not contain a conventional plasticizer or a material which is generally recognized in the art as a plasticizer for extruded films. The film can be sized and shaped to provide a controlled delivery of a therapeutic agent to the buccal, rectal, uterine, vaginal, abdominal, cranial, ophthalmic, nasal, sinus, or otic cavities. The film can also be used for the treatment of wounds.
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Citations
36 Claims
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1. A hot-melt extruded composition comprising:
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about 30-95% wt. of one or more water-soluble or water-swellable thermoplastic polymers;
about 1-25% wt. of polycarbophil;
about 1-60% wt. of poly(ethylene oxide);
about 0.1-10% wt. of an organic acid;
about 0.01-10% wt. of an antioxidant; and
about 0-50% wt. of a therapeutic agent;
wherein the composition has been hot-melt extruded without extensive degradation in the absence of a plasticizer.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 36)
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11. A hot-melt extruded film comprising:
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about 50-99% wt. of one or more water-soluble or water-swellable thermoplastic polymer or polymers;
about 0-50% wt. of a therapeutic agent; and
about 1-25% polycarbophil;
wherein the film has been hot-melt extruded without extensive degradation in the absence of a plasticizer.- View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 35)
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12. A hot-melt extruded film comprising:
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about 50-99% wt. of one or more water-soluble or water-swellable thermoplastic polymer or polymers;
about 0-50% wt. of a therapeutic agent; and
about 1-25% wt. of a bioadhesive polymer selected from the group consisting of polycarbophil, carbopol, a co-polymer of methyl vinyl ether and maleic acid or anhydride, one or more acrylic polymers, one or more polyacrylic acids, copolymers of these polymers, a water soluble salt of a co-polymer of methyl vinyl ether and maleic acid or anhydride, a combination thereof and their salts, wherein the film has been hot-melt extruded without extensive degradation in the absence of a plasticizer.
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24. A process for preparing a hot-melt extruded film comprising the steps of:
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providing a precursor composition comprising about 50-99% wt. of one or more water-soluble or water-swellable thermoplastic polymers;
about 0-50% wt of a therapeutic agent; and
about 1-25% wt. of a bioadhesive polymer; and
hot-melt extruding the precursor composition in the absence of a plasticizer to form a first film. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
a) one or more film modifiers present in an amount of up to about 20% wt.;
b) one or more cross-linking agents present in an amount of about 0.1-1 5% wt.;
c) a super-disintegrant or super-absorbent present in an amount of about 0.1-20% wt.;
d) a pH-modifying agent present in an amount of about 0.1-10.0% wt.;
e) a preservative present in an amount of about 0.01-0.5% wt.;
f) an organic acid present in an amount of about 0.1-10% wt.; and
g) a water insoluble polymer present in an amount of about 1.0-20%.
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32. The process of claim 31 wherein the precursor composition comprises at least two additional components.
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33. The process of claim 24 further comprising the steps of extruding a second composition to form a second film and laminating the first and second films.
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34. The process of claim 24 further comprising the step of cutting or shaping the film to adapt it for delivery of the therapeutic agent to the buccal, oral, rectal, vaginal, abdominal, cranial, ophthalmic, uterine, nasal, sinus or otic cavity.
Specification