Process for making an ingestible film

• US 7,357,891 B2
• Filed: 01/30/2004
• Issued: 04/15/2008
• Est. Priority Date: 10/12/2001
• Status: Active Grant

• Current Assignee: Aquestive Therapeutics, Inc.
• Original Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Inventors: Yang, Robert K., Fuisz, Joseph M., Fuisz, Richard C., Myers, Gary L.
• Primary Examiner(s): Lee; Edmund H.
• Application Number:
  US10/768,809
• Publication Number:
  US 20040258896A1
• Time in Patent Office: 1,537 Days
• Field of Search: None
• US Class Current: 264/211.12
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: B29C 48/08 flexible, e.g. films
• CPC Class Codes: B29C 48/91 Heating, e.g. for cross linking
• CPC Class Codes: B29C 48/919 using a bath, e.g. extruding into an open bath to coagulate or cool the material
• CPC Class Codes: F26B 13/10 Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials heating processes F26B3/00
• CPC Class Codes: F26B 13/104 supported by fluid jets only; Fluid blowing arrangements for flotation dryers, e.g. coanda nozzles

Abstract

The invention relates to film products containing desired levels of active components and methods of their preparation. 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. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.

Claims

1. A process for making an ingestible film having a substantially uniform distribution of components and a desired level of a pharmaceutical or biological active component, comprising the steps of:

(a) combining a polymer component, water and a pharmaceutical or biological active component to form a matrix with a uniform distribution of said components;

(b) forming a film from said matrix;

(c) providing a conveyor surface having top and bottom sides;

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

(e) drying said film within about 10 minutes or fewer by applying hot air currents to said bottom side of said conveyor surface with substantially no hot air currents on the top side of said surface and exposing said film to a temperature above a degradation temperature of said pharmaceutical or biological active component, wherein said degradation temperature is 70°

C. or higher,

wherein said pharmaceutical or biological active component is maintained at said desired level.

2. The process of claim 1, wherein said drying step maintains a non-self-aggregating uniform heterogeneity of said components throughout said film.

3. The process of claim 1, wherein said film is flexible when dried.

4. The process of claim 1, wherein said film is self-supporting.

5. The process of claim 1, wherein uniform distribution determines the amount of active material component per area.

6. 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 reduces the weight percent of said water to about 10% or less.

7. A process for making an ingestible film having a substantially uniform distribution of components and a desired level of a pharmaceutical or biological active component, comprising the steps of:

(a) forming a masterbatch premix of a water-soluble polymer component and water;

(b) feeding a predetermined amount of said premix to at least one mixer;

(c) adding a pharmaceutical or biological active component to said at least one mixer;

(d) mixing said pharmaceutical or biological active component and said predetermined amount of said premix to form a matrix having a uniform distribution of components;

(e) forming a film from said matrix;

(f) providing a conveyor surface having top and bottom sides;

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

(h) drying said film by applying heat to said bottom side of said conveyor surface and exposing said film to a temperature above a degradation temperature of said pharmaceutical or biological active component, wherein said degradation temperature is 70°

C. or higher,

wherein said drying step further comprises rapidly forming a visco-elastic film within about the first 4.0 minutes by applying hot air currents to said bottom side of said surface in the absence of hot air currents on the ton side of said surface; and

drying said visco-elastic film to form a self-supporting ingestible film,

wherein said pharmaceutical or biological active component is maintained at said desired level.

9. The process of claim 7, wherein said drying of said film reduces the weight percent of said water to about 10% or less.