Claims
- 1. A process for making a film having a substantially uniform distribution of components and a desired level of an active component, comprising the steps of:
(a) combining a polymer component, polar solvent and an active component to form a matrix with a uniform distribution of said components; (b) forming a film from said matrix; (c) providing a surface having top and bottom sides; (d) feeding said film onto said top side of said surface; and (e) drying said film by applying heat to said bottom side of said surface and exposing said film to a temperature above a degradation temperature of said active component, wherein said active component is maintained at said desired level.
- 2. The process of claim 1, wherein said film is ingestible.
- 3. The process of claim 1, wherein said drying step maintains a non-self-aggregating uniform heterogeneity of said components throughout said film.
- 4. The process of claim 1, wherein said film is flexible when dried.
- 5. The process of claim 1, wherein said film is self-supporting.
- 6. The process of claim 1, wherein uniform distribution determines the amount of active material component per area.
- 7. The process of claim 1, wherein a specific amount of the active material component may be obtained from said film by cutting said film to a predetermined size.
- 8. The process of claim 1, wherein said drying of said film occurs within about 10 minutes or fewer.
- 9. A film product containing a desired level of an active component formed by the steps of:
(a) combining a polymer, a polar solvent and an active component to form a material with a non-self-aggregating uniform heterogeneity; (b) forming said material into a film; and (c) drying said film at a temperature above a degradation temperature of said active component, wherein said active component is maintained at said desired level.
- 10. The film product of claim 9, wherein said film includes a top side and a bottom side and said drying includes drying said bottom side first.
- 11. The film product of claim 9, wherein said drying includes applying heat to said bottom side.
- 12. The film product of claim 9, wherein said polar solvent is a combination of water and a polar organic solvent.
- 13. The film product of claim 9, wherein said polar solvent is water.
- 14. The film product of claim 9, wherein said polar solvent added in step (a) has a weight percent of at least about 30%.
- 15. The film product of claim 9, wherein said drying of said film reduces the weight percent of said polar solvent to about 10% or less.
- 16. The film product of claim 9, wherein said drying of said film reduces the weight percent of said polar solvent to about 8% or less.
- 17. The film product of claim 9, wherein said drying of said film reduces the weight percent of said polar solvent to about 6% or less.
- 18. The film product of claim 9, wherein said active component is a member selected from the group consisting of medicaments, flavors, fragrances, enzymes, preservatives, sweetening agents, colorants, spices, vitamins, and combinations thereof.
- 19. The film product of claim 9, wherein said polymer is a cellulose derivative.
- 20. The film product of claim 9, wherein said polymer is a member selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium aginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch and combinations thereof.
- 21. The film product of claim 9, wherein said film product has a thickness of greater than about 0.1 mils.
- 22. The film product of claim 9, wherein said film product has a thickness of about 10 mils or fewer.
- 23. The film product of claim 9, wherein said film product has a substantially uniform thickness.
- 24. The film product of claim 9, wherein said film product is divided into dosage forms of substantially equal dimensions.
- 25. The film product of claim 24, wherein each of said dosage forms contains a substantially equal amount of said active.
- 26. The film product of claim 9, wherein said dosage forms contain an amount of said active that varies about 10% or less among said dosage forms.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims benefit to U.S. Provisional Application No. 60/443,741 filed Jan. 30, 2003, which is a continuation-in-part of PCT/US02/32575 filed Oct. 11, 2002, which claims priority to U.S. Application Ser. No. 10/074,272, filed Feb. 14, 2002 which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002; PCT/US02/32594, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. 60/414,276, filed Sep. 27, 2002, U.S. Application Ser. No. 10/074,272, filed Feb. 14, 2002, which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002; and PCT/US02/32542, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. 60/371,940, filed Apr. 11, 2002, U.S. Application Ser. No. 10/074,272, filed Feb. 14, 2002, which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002, the contents all of which are incorporated herein by reference.
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
PCT/US02/32575 |
Oct 2002 |
US |
Child |
10768809 |
Jan 2004 |
US |