EDIBLE FILM-STRIPS WITH MODIFIED RELEASE ACTIVE INGREDIENTS
The present invention is directed to an edible film that contains a modified release active ingredient. The active ingredient may be present in the edible film a variety of forms, including a modified release matrix, in a modified release particulate form, in microgel liquid filled beads or in a bilayer film. The present invention also includes edible films which comprise additional immediate release active ingredients.
1 . An edible film-strip comprising a modified release therapeutic active ingredient.
2 . An edible film strip of claim 1 wherein the active is present in less than 50% of the total cross sectional surface area of a major face of said film.
3 . An edible film strip of claim 1 wherein the modified release active ingredient is present in particulate form, and is distributed within segmented portions, wherein a segmented portion comprises, within a part of said segmented portion of a length of at least 2 millimeters to a maximum of at least 6 millimeters, a concentration of modified release active ingredient which is 10 percent greater by weight of total active than a separate part equal in length from a separate portion of the film.
4 . An edible film strip of claim 1 wherein the active ingredient is in a modified release particulate form.
5 . An edible film strip of claim 3 comprising an additional immediate release active ingredient.
6 . An edible film strip of claim 1 comprising an additional immediate release active ingredient which is apportioned within segmented portions, wherein a segmented portion comprises, within a part of said segmented portion of a length of at least 2 millimeters to a maximum of at least 6 millimeters, a concentration of active ingredient which is 10 percent greater by weight of total active than a separate part equal in length from a separate portion of the film.
7 . An edible film-strip comprising first portion comprising an immediate release active ingredient and a second portion comprising a modified release active ingredient.
8 . An edible film strip of claim 7 wherein the second portion comprises an active ingredient of the same type as the first portion.
9 . An edible film strip of claim 7 wherein the second portion comprises an active ingredient which is different than the active ingredient in the first portion.
10 . An edible film of claim 7 wherein the first portion is the first layer of a bilayer film and the second portion is the second layer of a bilayer film.
11 . An edible film of claim 10 wherein the second portion comprises the modified release active ingredient in modified release particulate form.
12 . An edible film of claim 10 wherein the second portion is a modified release matrix.
13 . An edible bilayer film strip comprising a first layer which is substantially free of a therapeutic active ingredient, and a second layer which comprises a modified release active ingredient.
14 . An edible film comprising a modified release active ingredient and liquid filled microgel beads.
15 . An edible film of claim 14 wherein the active ingredient is present in a modified release particulate form and the liquid filled microgel beads are substantially free of therapeutic active ingredient.
16 . An edible film of claim 14 wherein the liquid filled beads are modified release and comprise an active ingredient, and the film comprises an additional immediate release active ingredient.