Thin film with non-self-aggregating uniform heterogeneity 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.
1 . A process for making a film dosage unit having a substantially uniform distribution of components, comprising the steps of:
(a) providing at least one predetermined well which corresponds to an individual film dosage unit;
(b) combining and mixing a polymer component and solvent to form a matrix with a uniform distribution of the components;
(c) casting the matrix onto the at least one predetermined well; and
(d) drying the matrix through application of heat to form at least one film dosage unit defined by the predetermined well.
2 . The process of claim 1 , wherein the predetermined well has a bottom side and the step of drying the matrix comprises applying heat to the bottom side of the predetermined well.
3 . The process of claim 1 , further comprising the step of adding an active component to the matrix of step (b).
4 . The process of claim 1 , wherein the matrix has a viscosity of at least about 400 cps.
5 . The process of claim 1 , wherein the film dosage unit is ingestible.
6 . The process of claim 1 , wherein the film dosage unit is flexible when dried.
7 . The process of claim 1 , wherein the film dosage unit is self-supporting.
8 . The process of claim 3 , wherein uniform distribution determines the amount of active component per area.
9 . The process of claim 1 , wherein the solvent is a combination of water and a polar organic solvent.
10 . The process of claim 1 , wherein the solvent is water.
11 . The process of claim 1 , wherein the solvent added in step (b) has a weight percent of at least about 30%.
12 . The process of claim 3 , wherein the active component is a member selected from the group consisting of medicaments, flavors, fragrances, enzymes, preservatives, sweetening agents, colorants, spices, vitamins, and combinations thereof.
13 . The process of claim 1 , wherein the polymer component is a member selected from the group consisting of water soluble polymers, water insoluble polymers and combinations thereof.
14 . The process of claim 1 , wherein the polymer component is a cellulose derivative.
15 . The process of claim 13 , wherein the water soluble polymer is a member selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch and combinations thereof.
16 . The process of claim 3 , wherein each of the dosage units contains a substantially equal amount of the active component.
17 . A method of administering an accurately dosed film product, comprising the steps of:
(a) preparing a film dosage unit by the steps of:
(i) providing at least one predetermined well which corresponds to an individual film dosage unit;
(ii) combining and mixing a polymer component, a solvent and an active component to form a matrix with a uniform distribution of the components;
(iii) casting the matrix onto the at least one predetermined well; and
(iv) drying the matrix through application of heat to form at least one film dosage unit defined by the predetermined well;
(b) removing the film dosage unit from the predetermined well; and
(c) applying the film dosage unit to the oral cavity of a mammal.
18 . A film dosage unit in a predetermined well container comprising:
(a) a predetermined well; and
(b) a film dosage unit contained in said well, wherein said film dosage unit is formed by the steps of:
(i) combining and mixing a polymer component, a solvent and an active component to form a matrix with a uniform distribution of said components;
(ii) casting said matrix onto said predetermined well; and
(iii) drying said matrix through application of heat to form at least one film dosage unit defined by said predetermined well.
19 . A packaged film dosage unit comprising:
(a) a first laminate sheet comprising at least one predetermined well;
(b) a film dosage unit contained in said well, wherein said film dosage unit comprises a polymer component, a solvent and an active component; and
(c) a second laminate sheet covering said first laminate sheet.
20 . The packaged film dosage unit of claim 19 , wherein said first laminate sheet comprises a plurality of predetermined wells and a plurality of film dosage units are contained in said wells.