MULTI-LAYER FILMS HAVING UNIFORM CONTENT
The present invention relates to edible multi-layer films that dissolve in water. In particular, the edible multi-layer films have a first water-soluble film layer and one or more additional water-soluble film layers in at least partial face-to-face engagement with the first film layer. The film layers include a polymer composition which contains polyethylene oxide alone or in combination with at least one water-soluble polymer. The edible multi-layer films may include pockets defined between the layers that house an active component. Upon addition of water, the multi-layer film dissolves, thereby releasing the active component into the water.
1 . An edible multi-layer film for application to a mucosal membrane of the body comprising:
a first water-soluble film layer; and
one or more additional water-soluble film layers in at least partial face-to-face engagement with said first film layer,
wherein said first and additional film layers comprise a polymer composition which comprises at least one water-soluble or water swellable polymer and a solvent selected from the group consisting of water, polar organic solvents; ethanol, isopropanol, acetone, methylene chloride and combinations thereof; wherein at least one of said layers comprises a visco-elastic matrix having uniformity of content per unit volume of an active;
wherein said matrix has no more than a 10% by weight variance per unit area of said active throughout said matrix; and said multi-layer film has a 10% or less water content.
2 . The multi-layer film according to claim 1 , wherein said water-soluble polymer is selected from the group consisting of hydroxypropylmethyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, polydextrose and combinations thereof.
3 . The multi-layer film according to claim 1 , wherein said additional film layer is in full face-to-face engagement with said first film layer.
4 . The multi-layer film according to claim 1 , wherein said additional film layer is in perimetric face-to-face engagement with said first film layer.
5 . The multi-layer film according to claim 1 , wherein said first film layer and said additional film layer are joined at said at least partial face-to-face engagement.
6 . The multi-layer film according to claim 5 , wherein said first film layer and said additional film layer are heat sealed at said at least partial face-to-face engagement.
7 . The multi-layer film according to claim 1 , further comprising one or more pockets defined between said first film layer and said additional film layer.
8 . The multi-layer film according to claim 7 , further comprising an active component housed in said one or more pockets.
9 . The multi-layer film according to claim 1 , wherein said first film layer and said additional film layer are free of added plasticizers.
10 . The multi-layer film according to claim 1 , wherein said first film layer and said additional film layer further comprise a plasticizer.
11 . The multi-layer film according to claim 1 , wherein said first film layer is compositionally the same as said additional film layer.
12 . The multi-layer film according to claim 1 , wherein said first film layer is compositionally different from said additional film layer.
13 . The multi-layer film according to claim 1 , further comprising an outer container which houses said multi-layer film.
14 . The multi-layer film according to claim 1 , wherein said film comprises three-film layers.
15 . A consumable product comprising:
a) an outer container having one or more compartments;
b) one or more edible bi-layer films housed in said one or more compartments, wherein said bi-layer film comprises:
i) a first water-soluble film layer;
ii) a second water-soluble film layer which is in at least partial face-to-face engagement with said first film layer;
iii) one or more pockets defined between said first film layer and said second film layer; and
iv) a food product housed in said one or more pockets,
wherein said first and second film layers comprise a polymer composition which comprises:
about 20% to about 50% by weight polyethylene oxide;
about 25% to about 50% by weight hydroxypropylmethyl cellulose;
about 20% to about 75% by weight hydroxypropyl cellulose; and
up to about 20% by weight polydextrose; and
wherein at least one of said bi-layers comprises a visco-elastic matrix having uniformity of content per unit volume of an active; and
wherein said matrix has no more than a 10% by weight variance per unit area of said active throughout said matrix; and said multi-layer film has a 10% or less water content.
16 . A method of making an edible multi-layer film, comprising the steps of:
a) providing a first water-soluble film layer;
b) positioning a second water-soluble film layer in at least partial face-to-face engagement with the first film layer;
c) sealing the film layers together at the face-to-face engagement;
d) optionally positioning an additional water-soluble film layer in at least partial face-to-face engagement with the second film layer and sealing the additional layer to the second layer; and
e) repeating step d) as desired,
wherein said first, second and additional film layers comprise a polymer composition which comprises polyethylene oxide alone or in combination with at least one water-soluble polymer.
17 . The method according to claim 16 , wherein the step of providing a first water-soluble film layer comprises positioning a first water-soluble film layer over a plurality of cavities.
18 . An edible multi-layer film comprising:
a first water-soluble film layer; and
one or more additional water-soluble film layers in at least partial face-to-face engagement with said first film layer,
wherein said first and additional film layers comprise a polymer composition which comprises a first water-soluble polymer having a first glass transition temperature and a second water-soluble polymer having a second glass transition temperature which is at least about 20° C. higher than said first glass transition temperature; and
wherein at least one of said layers comprises a visco-elastic matrix having uniformity of content per unit volume of an active; and wherein said matrix has no more than a 10% by weight variance per unit area of said active throughout said matrix; and said multi-layer film has a 10% or less water content.
19 . An edible multi-layer film comprising:
a first water-soluble film layer; and
one or more additional water-soluble film layers in at least partial face-to-face engagement with said first film layer,
wherein said first and additional film layers comprise a polymer composition which comprises a first water-soluble polymer having a melt temperature and a second water-soluble polymer having a glass transition temperature which is at least about 10° C. higher than said melt temperature; and
wherein at least one of said layers comprises a visco-elastic matrix having uniformity of content per unit volume of an active; and
wherein said matrix has no more than a 10% by weight variance per unit area of said active throughout said matrix; and said multi-layer film has a 10% or less water content.
20 . An edible multi-layer film comprising:
a first water-soluble film layer; and
one or more additional water-soluble film layers in at least partial face-to-face engagement with said first film layer,
wherein said first and additional film layers comprise plasticizer and a polymer composition which comprises polyethylene oxide alone or in combination with at least one water-soluble or water swellable polymer and wherein said multi-layer film layers are uniform in thickness and compositional content; wherein said polyethylene oxide is present in amounts of about 12.5% to about 50% by weight of said polymer composition; and
wherein at least one of said layers comprises a visco-elastic matrix having uniformity of content per unit volume of an active; and
wherein said matrix has no more than a 10% by weight variance per unit area of said active throughout said matrix; and said multi-layer film has a 10% or less water content.