Biodegradable film dressing and method for its formation

• US 5,632,727 A
• Filed: 06/07/1995
• Issued: 05/27/1997
• Est. Priority Date: 10/03/1988
• Status: Expired due to Term

• Current Assignee: Atrix Laboratories, Inc. (TOLMAR Holding, Inc.)
• Original Assignee: Atrix Laboratories, Inc. (TOLMAR Holding, Inc.)
• Inventors: Fujita, Shawn M., Dunn, Richard L., Tipton, Arthur J.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/487,547
• Time in Patent Office: 720 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/19, 424/78.09, 424/424, 424/426, 424/443-449, 602/43, 602/46, 602/47, 602/900, 602/904
• US Class Current: 602/47
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/7015 Drug-containing film-forming compositions, e.g. spray-on
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/62 Compostable, hydrosoluble or hydrodegradable materials
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0026 Sprayable compositions
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 26/00 : Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
• CPC Class Codes: A61L 26/0019 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 26/0066 : Medicaments; Biocides
• CPC Class Codes: A61L 26/0076 : Sprayable compositions
• CPC Class Codes: A61L 26/0085 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 26/009 : Materials resorbable by the body
• CPC Class Codes: A61L 27/16 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 : Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: Y10S 602/90 : Method of making bandage structure
• CPC Class Codes: Y10S 602/904 : Film-forming bandage material

Abstract

The invention is directed to a biodegradable film dressing with or without additional therapeutic agents, an apparatus for spray delivery and a method for formation of the film dressing on a human or animal tissue. The film dressing is formed from a liquid composition of at least one biodegradable/bioerodible thermoplastic polymer in a pharmaceutically acceptable solvent. The spray apparatus includes a vessel containing the liquid composition with a dispensing means. The film is formed by dispensing, preferably by spraying, the liquid composition onto a tissue site and contacting the liquid composition with an aqueous based fluid to coagulate or solidify the film onto the human or animal tissue. The biodegradable film can be used to protect and to promote healing of injured tissue and/or to deliver biologically active agents.

Claims

1. A biodegradable microporous film dressing comprised of a skin and a core portion, the skin portion having pores with a smaller diameter than pores of the core portion;

wherein the film dressing is formed by contacting a composition comprising a biodegradable thermoplastic polymer that is insoluble in aqueous or body fluids, and an organic solvent that is soluble in aqueous or body fluids, with an aqueous or body fluid whereupon the composition coagulates or solidifies to form the microporous film dressing.

2. The film dressing of claim 1, wherein the film dressing is formed by administering the composition onto a tissue, and the core portion of the film dressing is oriented under the skin portion and in contact with the tissue.

3. The film dressing of claim 1, wherein the film dressing is formed by administering the composition onto a tissue, and the skin portion of the film dressing is oriented under the core portion and in contact with the tissue.

4. The microporous film dressing of claim 1, wherein the biodegradable thermoplastic polymer is selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyethylene glycols, polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyphosphazenes, polyhydroxybutyrates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, poly(amino acids), poly(methyl vinyl ether) and copolymers, terpolymers, and combinations thereof.

5. The microporous film dressing of claim 1, wherein the organic solvent is selected from the group consisting of N-methyl-2-pyrrolidone, 2-pyrrolidone, acetone, acetic acid, ethyl acetate, ethyl lactate, methyl acetate, methyl ethyl ketone, dimethylformamide, dimethylsulfoxide, dimethyl sulfone, tetrahydrofuran, caprolactam, decylmethylsulfoxide, oleic acid, propylene carbonate, N,N-diethyl-m-toluamide, and 1-dodecylazacycloheptan-2-one, and mixtures thereof.

6. The microporous film dressing of claim 1, wherein the diameter of the pores of the skin portion and the core portion is about 3-500 microns.

7. The microporous film dressing of claim 1, wherein the biodegradable film is capable of providing a mechanical barrier, a microbial barrier, or a combination thereof, on a tissue.

8. The microporous film dressing of claim 1, wherein water, oxygen, nutrients, or a combination thereof, can diffuse through the film.

9. The microporous film dressing of claim 1, wherein the biodegradable film has a low oxygen permeability, low water permeability, or a combination thereof.

10. The microporous film dressing of claim 1, wherein the microporous film is capable of providing a transdermal delivery system of a biologically-active agent.

11. The microporous film dressing of claim 1, wherein the film dressing is administered to skin, a surgical incision, a body cavity, burn, tissue defect, or a combination thereof.

12. The microporous film dressing of claim 1, wherein the film dressing is in the form of a bandage, suture, surgical barrier, wound dressing, or combination thereof.

13. The microporous film dressing of claim 1, wherein the film dressing is formed by administering the composition onto a tissue, and the film dressing binds the tissue to another tissue.

14. The microporous film dressing of claim 1, wherein the composition has a viscosity that allows the composition to be aerosolized, and the composition is sprayed onto tissue and coagulates or solidifies to provide an adhesive and cohesive film dressing on the surface of the tissue.

15. The microporous film dressing of claim 1, further comprising a pore-forming agent.

16. The microporous film dressing of claim 15, wherein the pore-forming agent is a sugar, salt, or water-soluble polymer, or a water-insoluble polymer that degrades to a water-soluble polymer.

17. The microporous film dressing of claim 15, wherein the pore-forming agent is a polymer selected from the group consisting of hydroxylpropylcellulose, carboxymethylcellulose, polyethylene glycol, polyvinylpyrrolidone, and combinations and mixtures thereof.

18. The microporous film dressing of claim 1, wherein the composition further comprises a biologically-active agent.

19. The microporous film dressing of claim 18, wherein the biologically-active agent is selected from the group consisting of antibacterial agents, antiviral agents, antifungal agents, antiparasitic agents, anti-inflammatory agents, antihistamines, anaesthetics, analgesics, anticholinergic agents, anti-neoplastic agents, growth factors, hormones, hormone regulators, cardiovascular agents, tranquilizers, central nervous system agents, osteo-inductive agents, kerolytic agents, ultraviolet screening agents, antiperspirants, vitamins, and mixtures and combinations thereof.

20. The microporous film dressing of claim 18, wherein the biologically-active agent is capable of altering cell growth, bone growth, tissue regeneration, wound healing, nerve stimulation, or a combination thereof.

21. The microporous film dressing of claim 18, wherein the biodegradable film further comprises an agent capable of altering percutaneous absorption of the biologically active agent.

22. The microporous film dressing of claim 21, wherein the absorption altering agent is selected from the group consisting of propylene glycol, glycerol, urea, diethyl sebecate, sodium lauryl sulfate, sodium laurye sulfate, sorbitan ethoxylates, oleic acid, pyrrolidone carboxylate esters, N-methyl pyrrolidone, N,N-diethyl-m-toluamide, dimethyl sulfoxide, alkyl methyl sulfoxides, and mixtures thereof.