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Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom

DC CAFC
  • US 7,425,292 B2
  • Filed: 02/14/2002
  • Issued: 09/16/2008
  • Est. Priority Date: 10/12/2001
  • Status: Expired due to Term
First Claim
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1. A process for making a self supporting, edible film having a substantially uniform distribution of components comprising:

  • (a) mixing an edible water-soluble polymer component, water and an active component comprising drug particles to form an edible matrix with a compositionally uniform distribution of said components;

    (b) deaerating said matrix by mixing;

    (c) forming a wet film from said deaerated matrix by coating or coating the film;

    (d) providing a surface having top and bottom sides;

    (e) feeding said film onto said top side of said surface; and

    (f) drying said film within about 10 minutes or fewer,wherein said drying step further comprises;

    (i) rapidiy forming a visco-elastic film having said drug particles uniformly distributed throughout within about the first 4.0 minutes by applying hot air currents at temperatures of about 60°

    C. to about 100°

    C. to said bottom side of said surface with substantially no top air flow to prevent flow migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components; and

    (ii) further drying said visco-elastic film to form a self-supporting edible film having drug particles uniformly distributed throughout.

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