Rapidly disintegrating films for delivery of pharmaceutical or cosmetic agents
A dissolvable film for delivering a pharmaceutical agent comprises a first water soluble polymer in an amount of from 2 to 35 weight percent and having a molecular weight from about 5,000 daltons to about 49,000 daltons; a second water soluble polymer in an amount of from 2 to 35 weight percent and having a molecular weight greater than 60,000 daltons; and a pharmaceutically active ingredient. The film has a thickness of about 20 microns to about 1200 microns and is configured to disintegrate after contact with a mucous membrane and thereby release the active ingredient.
1. A dissolvable film for delivering a pharmaceutical agent, comprising:
a first water soluble polymer in an amount of from 2 to 35 weight percent and having a molecular weight from about 5,000 daltons to about 49,000 daltons;
a second water soluble polymer in an amount of from 2 to 35 weight percent and having a molecular weight greater than 60,000 daltons; and
a pharmaceutically active ingredient;
wherein the film has a thickness of about 20 microns to about 1200 microns and is configured to disintegrate within about a minute after contact with a mucous membrane and thereby release the active ingredient.
2. The film of claim 1 wherein the active ingredient is selected from the group consisting of non-steroidal anti-inflammatories, opiate agonists, anesthetic/analgesics, and central nervous system agents.
3. The film of claim 1 wherein the second water soluble polymer has a molecular weight of about 60,000 to about 500,000 daltons.
4. The film of claim 1 wherein at least one of the water soluble polymers comprises poly(ethylene) oxide.
5. The film of claim 1 wherein at least one of the water soluble polymers comprises polyvinylpyrrolidone.
6. The film of claim 1 wherein the first water soluble polymer and the second water soluble polymer are different formulas.
7. The film of claim 1 further comprising a third water soluble polymer.
8. The film of claim 1 wherein the film is mucoadhesive.
9. The film of claim 1 wherein the film disintegrates within about 20 to 60 seconds after contact with a mucous membrane.
10. The film of claim 1 further comprising a starch component.
11. The film of claim 10 wherein the concentration of the starch component is about 2% to 50% of the weight of the film.
12. The film of claim 1 further comprising a glucose component.
13. The film of claim 12 wherein the concentration of the glucose component is about 2% to 20% of the weight of the film.
14. The film of claim 1 further comprising a plasticizer, a humectant, or both.
15. The film of claim 14 wherein the combined amount of the plasticizer and humectant is about 3% to 30% of the weight of the film.
16. The film of claim 1 further comprising a filler.
17. The film of claim 1 wherein the active ingredient is a taste masked drug.
18. The film of claim 1 wherein the concentration of the first water soluble polymer is about 2% to 10% of the weight of the film and wherein the concentration of the second water soluble polymer is about 2% to 10% of the weight of the film.
19. A dissolvable film for delivering a pharmaceutical or cosmetic agent, comprising:
a first water soluble polymer comprising polyvinylpyrrolidone having a molecular weight from about 5,000 daltons to about 49,000 daltons;
a second water soluble polymer comprising poly(ethylene) oxide having a molecular weight greater than 60,000 daltons; and
a pharmaceutically active ingredient;
wherein the film has a thickness of about 20 microns to about 1200 microns and is configured to disintegrate within about a minute after contact with a mucous membrane and thereby release the active ingredient.
20. The film of claim 1 , wherein the active ingredient is sumatriptan.