Films and Drug Delivery Systems Made Therefrom
The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.
1 . A film product comprising:
(a) a polymer component comprising (i) polyethylene oxide and (ii) a cellulose or a cellulose derivative;
(b) an anti-emetic or anti-nauseant active;
(c) an alkaline component;
(d) a viscosity adjuster;
(e) a sweetener;
(f) a flavor;
(g) a coloring agent; and
(h) an anti-oxidant.
2 . The film product according to claim 1 , wherein the polyethylene oxide has molecular weight between about 100,000 and about 900,000.
3 . The film product according to claim 1 , wherein the polyethylene oxide has a molecular weight between about 100,000 and about 300,000.
4 . The film product according to claim 1 , wherein the cellulose or cellulose derivative is hydroxypropyl methyl cellulose.
5 . The film product according to claim 1 , wherein the ratio of PEO to cellulose or cellulose derivative in the polymer component is about 1:4 or greater.
6 . The film product according to claim 1 , wherein the ratio of PEO to cellulose or cellulose derivative in the polymer component is about 1:1.8.
7 . The film product according to claim 1 , wherein the anti-emetic or anti-nauseant active is selected from the group consisting of granisetron, nabilone, and salts thereof.
8 . The film product according to claim 1 , wherein the alkaline component is calcium carbonate, sodium bicarbonate, or a combination thereof.
9 . The film product according to claim 1 , wherein the sweetener is erythritol, sucralose, or a combination thereof.
10 . The film product according to claim 1 , wherein the flavor is peppermint, monoammonium glycyrrhzinate, or a combination thereof.
11 . The film product according to claim 1 , wherein the polymer component comprises about from about 20% to about 100% by weight of polyethylene oxide and from 0% to about 80% by weight of cellulose or cellulose derivative.
12 . The film product according to claim 1 , wherein the polymer component comprises about 35% by weight of polyethylene oxide and about 65% by weight of cellulose or cellulose derivative.