Dissolvable adhesive films for delivery of pharmaceutical or cosmetic agents

• US 20080124381A1
• Filed: 10/11/2007
• Published: 05/29/2008
• Est. Priority Date: 10/24/2003
• Status: Active Grant

• Current Assignee: Adhesives Research Inc., Innolux Display Corporation (InnoLux Corporation)
• Original Assignee: Adhesives Research Inc.
• Inventors: Moritz, Cathy M., Barnhart, Scott D., Full, Andrew P., Meathrel, William G., Cramer, George, Robertson, Mary
• Granted Patent: US 9,248,146 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 2013/00685 soluble in liquid, e.g. of particular pH
• CPC Class Codes: A61F 2013/0071 containing active agent
• CPC Class Codes: A61F 2013/00719 adhesives for use on wounds
• CPC Class Codes: A61F 2013/00906 for transcutaneous or transdermal drugs application
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 2013/00914 with deodorising or perfuming means
• CPC Class Codes: A61K 31/716 Glucans
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• 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: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body
• CPC Class Codes: A61L 2300/254 Enzymes, proenzymes
• 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 2300/412 : Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/418 : Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/604 : Biodegradation
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin
• CPC Class Codes: C08L 1/28 : Alkyl ethers

Abstract

The invention provides integratable adhesive films containing a mixture of high molecular weight and low molecular weight water soluble components; and a pharmaceutically or cosmetically active ingredient. Optionally, the films contain a starch component, a polysaccharide component, a filler, a plasticizer and/or humectant. The films are preferably in the form of an adhesive layer having a thickness sufficient to disintegrate, when exposed to a moist environment and/or a trigger compound, and release the active ingredient. The films can be cut to any desired size or shape to provide conveniently useable unit dosage forms for administration to wet or moist body surfaces for human, pharmaceutical, cosmetic, or veterinary applications. The invention further provides various end uses and methods of administering the film compositions.

Claims

1. A method for delivering a pharmaceutically or cosmetically active agent to a surface of a human or animal body, comprising:

providing a dissolvable film containing a first water soluble component having a molecular weight from about 5,000 daltons to about 60,000 daltons;

a second water soluble component having a molecular weight greater than about 60,000 daltons; and

at least one pharmaceutically or cosmetically active agent;

wherein the film contains substantially no surfactant, and wherein the first and second water soluble components are present in relative amounts such that the film disintegrates after contact with moisture to release the active agent; and

applying the dissolvable film to adhere to the body surface for a sufficient time for the film to release the active agent.

2. The method of claim 1 wherein at least one of the water soluble components comprises hydroxypropyl cellulose.

3. The method of claim 1 wherein at least one of the water soluble components comprises hydroxypropyl methylcellulose.

4. The method of claim 1 wherein the film is adhesive when exposed to moisture.

5. The method of claim 1 wherein the film is in the form of a monolayer.

6. The method of claim 1 wherein the film is part of a multilayer device.

7. The method of claim 6 wherein the multilayer device comprises a structure selected from the group consisting of a bandage, wound dressing, and gauze structure.

8. The method of claim 1 wherein the dissolvable film comprises multiple layers of dissolvable films.

9. The method of claim 8 wherein one or more of the multiple layers have different dissolution rates.

10. The method of claim 1 wherein the dissolvable film comprises:

at least one hydroxypropyl methylcellulose polymer having a molecular weight of about 30,000 daltons;

at least one hydroxypropyl methylcellulose polymer having a molecular weight of about 90,000 daltons;

at least one hydroxypropyl cellulose having a molecular weight of about 140,000 daltons;

at least one starch component;

at least one polysaccharide component; and

at least one plasticizer and/or humectant;

the film being essentially free of surfactants.

11. The method of claim 10 wherein the film further comprises polyvinyl pyrrolidone.

12. The method of claim 10 wherein the plasticizer is selected from the group consisting of sorbitol, polyethylene glycol, and polyethylene oxide.

13. The method of claim 10 wherein the polysaccharide component comprises maltodextrin.

14. The method of claim 1, wherein the film is applied to an internal body surface after surgery or injury.

15. The method of claim 1 wherein the film disintegrates to release the active ingredient within about 1 second to about 24 hours after contact with or exposure to a moist body surface.

16. The method of claim 1 wherein the film is in a unit dosage form.

17. A method of treating a skin irritation comprising administering to the skin irritation a dissolvable film containing a first water soluble component having a molecular weight from about 5,000 daltons to about 60,000 daltons;

a second water soluble component having a molecular weight greater than about 60,000 daltons; and

at least one antimicrobial agent;

wherein the film contains substantially no surfactant, and wherein the first and second water soluble components are present in relative amounts such that the film disintegrates after contact with moisture to release the antimicrobial agent.

18. The method of claim 17 wherein the skin irritation is diaper rash.

19. A method of treating a wound comprising administering to the wound a dissolvable film containing a first water soluble component having a molecular weight from about 5,000 daltons to about 60,000 daltons;

a second water soluble component having a molecular weight greater than about 60,000 daltons; and

at least one pharmaceutically active agent selected from the group consisting of an analgesic, an enzyme, an active agent for aiding in blood coagulation, and an active agent for promoting tissue growth;

wherein the film contains substantially no surfactant, and wherein the first and second water soluble components are present in relative amounts such that the film disintegrates after contact with moisture to release the pharmaceutically active agent.

20. The method of claim 19 wherein the pharmaceutically active agent is benzocaine.

21. The method of claim 19 wherein the pharmaceutically active agent is papain.

22. The method of claim 19 wherein the pharmaceutically active agent is aluminum sulfate.

23. The method of claim 19 wherein the pharmaceutically active agent is allantoin.

24. A method for delivering a pharmaceutically or cosmetically active agent to a surface of a human or animal body, comprising:

providing a dissolvable film containing a first water soluble component having a molecular weight from about 5,000 daltons to about 60,000 daltons;

a second water soluble component having a molecular weight greater than about 60,000 daltons;

a reactive component capable of reacting with a trigger compound on the surface to initiate film disintegration; and

at least one pharmaceutically or cosmetically active agent, wherein the film contains substantially no surfactant; and

applying the dissolvable film to adhere to the body surface for a sufficient time for the film to disintegrate and release the active agent.

25. The method of claim 24 wherein the trigger compound is selected from the group consisting of cellulose, amylase, glucose oxidase, metalloproteinase, collagenase, alkaline phosphatase, elastase, and aqueous alkali.