EFFERVESCENCE POLYMERIC FILM DRUG DELIVERY SYSTEM

• US 20010006677A1
• Filed: 10/29/1996
• Published: 07/05/2001
• Est. Priority Date: 10/29/1996
• Status: Abandoned Application

• Current Assignee: James W. Mcginity, Joseph Roy Robinson
• Original Assignee: James W. Mcginity, Joseph Roy Robinson
• Inventors: MCGINITY, JAMES W., ROBINSON, JOSEPH R.
• Application Number:
  US08/741,432
• Publication Number:
  US 20010006677A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence
• 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

Abstract

According to the present invention, effervescent controlled release water soluble or swellable hot-melt extruded films are provided. Such films comprise a hot-melt extrudable water soluble or swellable binder, an active ingredient, an effervescent couple and optionally another compound such as a plasticizer. The films are made by a hot-melt extrusion process. Bioadhesive effervescent films can also be made by the invention.

Claims

1. An effervescent water soluble or swellable controlled release hot-melt extruded thin film comprising:

a water soluble or swellable hot-melt extrudable effervescent film binder present in an amount of about 40% to about 99.9% by weight of the film;

an effective amount of an active ingredient present in an amount of about 0.05% to about 60% by weight of the film;

a plasticizer present in an amount of about 0% to about 50% of the film; and

an effervescent couple present in an amount of about 0.1% to about 60% of the film.

6. An effervescent controlled release hot-melt film of

claim 1

or

3

, further comprising a bioadhesive.

7. The effervescent controlled release hot-melt extruded thin film of

claim 1

or

3

further defined comprising a plasticizer in an amount of about 0.5% to about 60% by weight of the film.

8. The effervescent controlled release hot-melt extruded thin film of

claim 1

or

3

further defined as a multi-layer film.

2. A method for preparing an effervescent controlled release hot-melt extruded thin film comprising:

providing a hot-melt extruded effervescent granule comprising;

a hot-melt extrudable effervescent granule binder and an effervescent couple;

mixing said effervescent granule with a hot-melt extrudable effervescent film binder, and an active ingredient to form an effervescent mixture; and

hot-melt extruding said effervescent mixture to form said film.

3. The method of

claim 2

wherein the effervescent granule is mixed with a plasticizer.

4. An effervescent controlled release hot-melt extruded thin film comprising:

a water soluble or swellable hot-melt extrudable effervescent film binder present in an amount of about 40% to about 99.9% by weight of the film;

a plasticizer present in an amount of about 0% to about 40% by weight of the film; and

an effervescent granule present in an amount of about 3% to about 15% by weight of the film.

5. The effervescent water soluble or swellable controlled release hot-melt extruded thin film of

claim 4

wherein the hot-melt extruded thin film is a single layer film.

9. A method for preparing a bioadhesive effervescent controlled release hot-melt extruded soluble or swellable two-layered thin film comprising:

providing a bioadhesive thin film;

mixing an effervescent couple with a hot-melt extrudable water-soluble or swellable effervescent film binder, an effective amount of an active ingredient to form an effervescent mixture;

hot-melt extruding said effervescent mixture to form an effervescent single-layered hot-melt extruded water soluble or swellable film; and

pressing said effervescent single-layered hot-melt extruded water soluble or swellable film onto said bioadhesive thin film.

10. The method of

claim 9

wherein the effervescent couple is mixed with a plasticizer.