Multilayer barrier film for transdermal drug delivery system and ostomy applications

• US 5,567,488 A
• Filed: 03/23/1994
• Issued: 10/22/1996
• Est. Priority Date: 09/16/1993
• Status: Expired due to Term

• Current Assignee: The Dow Chemical Company (Dow, Inc.)
• Original Assignee: The Dow Chemical Company (Dow, Inc.)
• Inventors: Allen, Scott I., Ferguson, Michael, Tung, Harvey
• Primary Examiner(s): NOLD, CHARLES R
• Application Number:
  US08/216,903
• Time in Patent Office: 944 Days
• Field of Search: 428/483, 428/516, 428/34.1, 428/424.2, 428/424.8, 604/332, 604/338, 604/890.1, 604/891.1, 604/892.1, 424/443, 424/444, 424/445
• US Class Current: 428/34.1
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: B32B 2307/31 Heat sealable
• CPC Class Codes: B32B 2307/7244 Oxygen barrier
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2327/06 PVC, i.e. polyvinylchloride
• CPC Class Codes: B32B 2375/00 Polyureas; Polyurethanes
• 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 27/304 comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
• CPC Class Codes: B32B 27/40 comprising polyurethanes
• CPC Class Codes: Y10T 428/13 Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/31522 Next to metal
• CPC Class Codes: Y10T 428/31573 Next to addition polymer of ethylenically unsaturated monomer
• CPC Class Codes: Y10T 428/31587 Hydrocarbon polymer [polyethylene, polybutadiene, etc.]
• CPC Class Codes: Y10T 428/31797 Next to addition polymer from unsaturated monomers

Abstract

An oxygen and moisture impermeable multilayer barrier film is provided including a barrier layer comprising a homopolymer of vinylidene chloride or a copolymer of vinylidene chloride and vinyl chloride or methyl methacrylate. The barrier layer is coextruded with or laminated to at least one heat sealable skin layer comprising a thermoplastic polyurethane, a substantially linear copolymer of ethylene and an α-olefin, or a homogeneously-branched linear olefin resin to form the barrier film. The multilayer film may be used for reusable ostomy bags, for systems for the transdermal delivery of drugs, and for heat sealable bags used in packaging.

Claims

1. An oxygen and moisture impermeable multilayer barrier film having a heat seal strength of at least about 1.0 lb/inch width of said film, said film comprising a barrier layer and at least one heat sealable skin layer, said skin layer comprising a thermoplastic polymer having a 2% secant modulus of less than about 15,000 psi in both the machine and transverse directions, said barrier film exhibiting a noise of less than about 85 dB when subjected to flexing through a 65°

angle at 0.45 Hz.

2. The multilayer barrier film of claim 1 wherein said skin layer comprises either a thermoplastic polyurethane, a substantially linear copolymer of ethylene and an α

-olefin resin having a density in the range of from about 0.87-0.92 gm/cc and from about 0.01 to 3 long chain branches/1000 carbon atoms along the polymer backbone, or a homogeneously-branched linear olefin resin.

3. The multilayer barrier film of claim 1 wherein said heat sealable skin layer comprises a thermoplastic polyurethane, and said skin layer contains from 0 to 10% by weight of a copolymer of ethylene and vinyl acetate.

4. The multilayer barrier film of claim 1 wherein said barrier layer is selected from the group consisting of a homopolymer of vinylidene chloride, a copolymer of vinylidene chloride with vinyl chloride or methyl methacrylate.

5. The multilayer barrier film of claim 1 wherein said film has an oxygen transmission rate of less than about 90 cc/m² /day·

atm.

6. The multilayer barrier film of claim 1 wherein said barrier layer is positioned between two heat sealable skin layers.

7. The multilayer barrier film of claim 6 wherein said skin layers comprise 70% by weight of said film and said moisture barrier layer comprises 30% by weight of said film.

8. The multilayer barrier film of claim 1 wherein said skin layers contain from about 0.5-5% by weight of a slip additive/antiblocking agent package.

9. The multilayer barrier film of claim 3 wherein said skin layers contain from 1-10% by weight of a copolymer of ethylene and vinyl acetate.

10. The multilayer barrier film of claim 1 wherein said skin layer is a substantially linear copolymer of ethylene and an α

-olefin having a density in the range of from about 0.87-0.92 gm/cc, from about 0.01 to 3 long chain branches/1000 carbon atoms along the polymer backbone.

11. The multilayer barrier film of claim 10 including an intermediate tie layer of a copolymer of ethylene and vinyl acetate between said barrier layer and said skin layer.

12. The multilayer barrier film of claim 1 wherein said barrier layer comprises a homopolymer of vinylidene chloride or a copolymer of vinylidene chloride with vinyl chloride or methyl methacrylate, and from about 1-6% of a copolymer of ethylene and vinyl acetate.

13. The multilayer barrier film of claim 1 wherein said barrier film further includes:

a) an adhesive containing an active drug adhered to one surface of said barrier film; and

b) a controlled release membrane adjacent said adhesive and adapted to controllably release said drug to a patient'"'"'s skin.

14. The multilayer barrier film of claim 13 further including an adhesive adhered to a least a portion of said controlled release membrane and a release liner overlying said adhesive and release membrane to form a system for transdermal delivery of drugs.

15. The multilayer barrier film of claim 1 wherein said at least one skin layer is heat sealed along its edges to form a bag or pouch.