pH-Sensitive mucoadhesive film-forming gels and wax-film composites suitable for topical and mucosal delivery of molecules
First Claim
1. A pharmaceutical gel comprising:
- a solvent vehicle comprising 25 to 100 parts by weight water or buffered water and 0 to 75 parts by weight of ethanol, propylene glycol, glycerin, polyethylene glycol, or combinations thereof, where the solvent vehicle is 100 parts by weight total;
at least one water-insoluble swellable mucoadhesive polymer, wherein the water-insoluble swellable mucoadhesive polymer is crossed-linked polyacrylic acid;
at least one pH-sensitive anionic copolymer of methacrylic acid and methacrylic acid esters, which forms a film when applied to skin or a mucosal surface, andat least one molecule of interest.
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Accused Products
Abstract
The present invention relates to pH-sensitive mucoadhesive film-forming gels and wax-film composites suitable for topical and mucosal delivery of molecules of interest, namely active pharmaceuticals. The gels comprise a pharmaceutically acceptable pH-sensitive polymer that responds to a lowering of pH by precipitating into films when in contact with the skin or mucosal surface. The films also comprise an adhesive polymer that allows the film to remain in contact with the tissue for an extended period of time. The wax-film composites comprise a bi-layer film having both the said pH-sensitive mucoadhesive layer to promote strong adherence to the skin and mucosal surfaces as well as a specially bonded wax layer intended to extend the adherence of the film to tissues for a prolonged period of time. The invention also relates to the use of said pH-sensitive film-forming gels and wax-film composites to deliver molecules of interest, such as small molecules, peptides, proteins, and nucleic acids either locally to act at the site of administration or for the absorption of said molecules of interest across biological membranes into the systemic circulation.
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Citations
15 Claims
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1. A pharmaceutical gel comprising:
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a solvent vehicle comprising 25 to 100 parts by weight water or buffered water and 0 to 75 parts by weight of ethanol, propylene glycol, glycerin, polyethylene glycol, or combinations thereof, where the solvent vehicle is 100 parts by weight total; at least one water-insoluble swellable mucoadhesive polymer, wherein the water-insoluble swellable mucoadhesive polymer is crossed-linked polyacrylic acid; at least one pH-sensitive anionic copolymer of methacrylic acid and methacrylic acid esters, which forms a film when applied to skin or a mucosal surface, and at least one molecule of interest. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification