Instantly wettable oral film dosage form without surfactant or polyalcohol

摘要

An instantly wettable and rapidly disintegrating oral film dosage form without a surfactant and without a polyalcohol was achieved by combining at least one water soluble polymer that is not a copolymer of vinylpyrrolidone, at least one active agent, a copolymer of vinylpyrrolidone and titanium dioxide. In certain embodiments, the film comprises hydroxypropyl cellulose or a combination of hydroxypropyl cellulose and a polymer or copolymer of vinylpyrrolidone or a substituted vinylpyrrolidone as the water soluble polymer(s). A plasticizer, and optional additives selected from synthetic sweeteners, natural sweeteners, flavorants, antioxidants, colorants, and opacifiers, can be added to the disclosed film oral dosage forms.

主权项

1. An instantly wettable, rapidly disintegrating film oral dosage form, comprising:
at least one water soluble polymer that is not a copolymer of vinylpyrrolidone; at least one copolymer of vinylpyrrolidone in an amount that is effective to increase stiffness of the film as compared to a film without the at least one copolymer of vinylpyrrolidone; titanium dioxide in an amount that is effective to increase a rate of disintegration of the film in an aqueous medium, wherein the ratio by weight of copolymer of vinylpyrrolidone to titanium dioxide in the film is from 3:1 to 5:1; and at least one active agent; wherein the film oral dosage form is substantially free of surfactants and polyalcohols.