MELT-EXTRUDED FILM

• US 20110236666A1
• Filed: 02/25/2011
• Published: 09/29/2011
• Est. Priority Date: 03/26/2010
• Status: Abandoned Application

• Current Assignee: Mark J. Hall, Michael D. Read, Uma Shrestha
• Original Assignee: Mark J. Hall, Michael D. Read, Uma Shrestha
• Inventors: Read, Michael D., Hall, Mark J., Shrestha, Uma
• Application Number:
  US13/035,233
• Publication Number:
  US 20110236666A1
• Time in Patent Office: Days
• US Class Current: 428/220
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• 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: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/08 flexible, e.g. films
• CPC Class Codes: B29C 55/00 Shaping by stretching, e.g. drawing through a die; Apparatus therefor B29C61/08 takes precedence
• CPC Class Codes: B29K 2001/00 Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
• CPC Class Codes: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2031/00 Use of polyvinylesters or derivatives thereof as moulding material
• CPC Class Codes: B29K 2033/08 Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2105/0035 Medical or pharmaceutical agents
• CPC Class Codes: B29K 2995/005 Oriented
• CPC Class Codes: B29K 2995/0051 mono-axially
• CPC Class Codes: B29K 2995/0062 water-soluble
• CPC Class Codes: B29L 2007/008 Wide strips, e.g. films, webs
• CPC Class Codes: B32B 2038/0028 Stretching, elongating
• CPC Class Codes: B32B 2250/24 All layers being polymeric
• CPC Class Codes: B32B 2270/00 Resin or rubber layer containing a blend of at least two different polymers
• CPC Class Codes: B32B 2307/7166 Water-soluble, water-dispersible
• CPC Class Codes: B32B 2307/732 Dimensional properties
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/18 : characterised by the use of special additives
• CPC Class Codes: B32B 27/28 : comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
• CPC Class Codes: B32B 27/285 : comprising polyethers
• CPC Class Codes: B32B 27/30 : comprising vinyl (co)polymers; comprising acrylic (co)polymers
• CPC Class Codes: B32B 27/306 : comprising vinyl acetate or vinyl alcohol (co)polymers
• CPC Class Codes: B32B 27/308 : comprising acrylic (co)polymers
• CPC Class Codes: B32B 37/153 : at least one layer is extruded and immediately laminated while in semi-molten state
• CPC Class Codes: C08J 2301/28 : Alkyl ethers
• CPC Class Codes: C08J 2371/02 : Polyalkylene oxides
• CPC Class Codes: C08J 5/18 : Manufacture of films or sheets

Abstract

A melt-extruded film is produced by a process which comprises the steps of blending a) a water-soluble polymer, b) an active ingredient, and c) optional additives and subjecting the blend to melt-extrusion to produce an extruded melt and drawing the extruded melt at a draw-down ratio of from 1.5 to 20 to a film of a thickness of at least 0.04 mm.

Claims

1. A process for producing a melt-extruded film comprising the steps of blending a) a water-soluble polymer, b) an active ingredient, and c) optional additives and subjecting the blend to melt-extrusion to produce an extruded melt and drawing the extruded melt at a draw-down ratio of from about 1.5 to about 20 to a film of a thickness of at least about 0.04 mm.

2. The process of claim 1 wherein the film is extruded to a film at a draw-down ratio of from about 2.5 to about 17.

3. The process of claim 1 wherein the optional additive is a disintegrant.

4. The process of claim 1 wherein the combined amount of the water-soluble polymer a) and the active ingredient b) is at least about 75 percent, based on the total weight of the blend.

5. The process of claim 1 wherein the amount of the active ingredient b) is from about 10 to about 60 percent, based on the total weight of the blend.

6. The process of claim 1 wherein the water-soluble polymer is a cellulose ether, a polyethylene oxide, a polyvinylpyrrolidone or a polymer comprising in polymerized form acrylic acid, methacrylic acid, a salt of acrylic acid or methacrylic acid, vinylacetate, ethylene imine, or an oxyethylene alkylether.

7. The process of claim 1 wherein the water-soluble polymer is a cellulose ether or a polyethylene oxide or a combination of a cellulose ether and a polyethylene oxide.

8. The process of claim 1 wherein the amount of the water-soluble polymer a) is from about 15 to about 90 percent, based on the total weight of the blend.

9. The process of claim 1 for producing a mono-layered melt-extruded film.

10. The process claim 1 wherein the water-soluble polymer a) has a softening point above the melting point of the active ingredient b).

11. The process of claim 1 wherein the blend is subjected to melt-extrusion, caused to exit an extruder die and drawn to a film using a take-up roll to provide a film of a melt draw elongation of from about 50 to about 5000%, wherein the melt draw elongation=((Vf−

Vi)/Vi)*100, where Vi is the film velocity at the extruder die and Vf is the film velocity at the take-up roll.

12. The process of claim 11 wherein the melt draw elongation is from about 200 to about 2500%.

13. The process of claim 1 for producing a film of a thickness of from about 0.05 mm to about 0.30 mm.

14. The process of claim 1 wherein the film of a thickness of at least about 0.04 mm is combined with one or more other films during or after melt-extrusion to produce a multi-layered film.

15. A melt-extruded film producible according to claim 1.