Granted Patent B2

US 10,034,833 · App. 15/069,875 · Granted Jul 31, 2018

Abstract

Claims (56)

1. A self-supporting layered film dosage composition comprising:

at least a first region including:

a. a polymeric carrier matrix;

b. a therapeutically effective amount of apomorphine or a pharmaceutically acceptable salt thereof as an agonist; and

c. a buffer,

wherein the ratio of said buffer to apomorphine or a pharmaceutically acceptable salt thereof is from about 2:1 to about 1:5, and at least a second region,

wherein the at least first region and the at least second region are arranged in a layered film dosage; and said layered film dosage provides a local pH of the agonist containing region is between about 5 to about 9;

and wherein said self-supporting layered film dosage composition disperses in an oral cavity in about 30 minutes or less.

2. The self-supporting film dosage composition of claim 1 , wherein said composition contains from about 2 to about 16 mg of apomorphine or a pharmaceutically acceptable salt thereof.

3. The self-supporting film dosage composition of claim 1 , wherein said composition disperses and dissolves in the oral cavity between about 1 minute and about 3 minutes.

4. The self-supporting film dosage composition of claim 1 , wherein said composition has a thickness of from 0.1 to 10 mils.

5. The self-supporting film dosage composition of claim 1 , wherein said polymeric carrier matrix comprises polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or a combination thereof.

6. The self-supporting film dosage composition of claim 1 , wherein said composition further comprises an FD&C coloring agent.

7. The self-supporting film dosage composition of claim 1 , wherein said composition further comprises glycerol, glycerol monoacetate, diacetate or triacetate, triacetin, polysorbate, cetyl alcohol, propylene glycol, sorbitol, sodium diethylsulfosuccinate, triethyl citrate, or tributyl citrate.

8. The self-supporting film dosage composition of claim 1 , wherein said composition further comprises glycerol.

9. The self-supporting film dosage composition of claim 1 , wherein said composition further comprises a sweetener.

10. The self-supporting film dosage composition of claim 9 , wherein said sweetener is sucralose.

11. The self-supporting film dosage composition of claim 1 , wherein said self-supporting film dosage composition has a thickness of from 0.1 to 10 mils.

12. The self-supporting film dosage composition of claim 1 wherein the dosage contains regions of differing dissolution rates.

13. The self-supporting film dosage composition of claim 1 wherein the composition is a dual region product.

14. The self-supporting film dosage composition of claim 1 wherein the buffer includes a first buffering system.

15. The self-supporting film dosage composition of claim 14 wherein the self-supporting film dosage composition further includes a second buffering system.

16. A self-supporting layered film dosage composition comprising:

at least a first region including:

a polymeric carrier matrix comprising polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or a combination thereof;

a therapeutically effective amount of apomorphine or a pharmaceutically acceptable salt thereof as an agonist, and

a buffer,

wherein the ratio of said buffer to apomorphine or a pharmaceutically acceptable salt thereof is from about 2:1 to about 1:5, and at least a second region,

wherein the at least first region and the at least second region are arranged in a layered film dosage; and said layered film dosage provides a local pH of the agonist containing region is between about 5 to about 9;

and wherein said self-supporting layered film dosage composition disperses in an oral cavity in about 30 minutes or less.

17. The self-supporting film dosage composition of claim 16 , wherein said composition further comprises glycerol, glycerol monoacetate, diacetate or triacetate, triacetin, polysorbate, cetyl alcohol, propylene glycol, sorbitol, sodium diethylsulfosuccinate, triethyl citrate, or tributyl citrate and wherein said composition further comprises a sweetener.

18. The self-supporting film dosage composition of claim 16 , wherein said composition further comprises an FD&C coloring agent.

19. The self-supporting film dosage composition of claim 16 , wherein said composition further comprises glycerol.

20. The self-supporting film dosage composition of claim 16 , wherein said sweetener is sucralose.

21. The self-supporting film dosage composition of claim 16 , wherein the composition comprises about 2 to about 16 mg of apomorphine or a pharmaceutically acceptable salt thereof.

22. The self-supporting film dosage composition of claim 16 , wherein said composition disperses and dissolves in the oral cavity between about 1 minute and about 3 minutes.

23. The self-supporting film dosage composition of claim 16 , wherein said self-supporting film dosage composition has a thickness of from 0.1 to 10 mils.

24. The self-supporting film dosage composition of claim 16 wherein the dosage contains regions of differing dissolution rates.

25. The self-supporting film dosage composition of claim 16 wherein the composition is a dual region product.

26. The self-supporting film dosage composition of claim 16 wherein the buffer includes a first buffering system.

27. The self-supporting film dosage composition of claim 26 wherein the self-supporting film dosage composition further includes a second buffering system.

28. A self-supporting layered film dosage composition comprising:

at least a first region including:

a polymeric carrier matrix comprising polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or a combination thereof; and

a therapeutically effective amount of apomorphine or a pharmaceutically acceptable salt thereof as an agonist and

a buffer,

wherein the ratio of said buffer to apomorphine or a pharmaceutically acceptable salt thereof is from about 2:1 to about 1:5,

and at least a second region,

wherein the at least first region and the at least second region are arranged in a layered film dosage; and said layered film dosage provides a local pH of the agonist containing region is between about 5 to about 9;

and wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;

wherein said composition further comprises glycerol and sucralose

and wherein said self-supporting layered film dosage composition disperses in an oral cavity in about 30 minutes or less.

29. The self-supporting film dosage composition of claim 28 wherein the dosage contains regions of differing dissolution rates.

30. The self-supporting film dosage composition of claim 28 wherein the composition is a dual region product.

31. The self-supporting film dosage composition of claim 28 wherein the buffer includes a first buffering system.

32. The self-supporting film dosage composition of claim 31 wherein the self-supporting film dosage composition further includes a second buffering system.

Assignments (10)