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Claims for Patent: 8,747,896

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Claims for Patent: 8,747,896

Title:Mucosal bioadhesive slow release carrier for delivering active principles
Abstract: A mucosal bioadhesive slow release carrier comprising an active principle and devoid of starch, lactose, which can release the active principal for a duration of longer than 20 hours. This bioadhesive carrier contains a diluent, an alkali metal alkylsulfate, a binding agent, at least one bioadhesive polymer and at least one sustained release polymer, as well as a method for its preparation.
Inventor(s): Costantini; Dominique (Paris, FR), Lemarchand; Caroline (Paris, FR)
Assignee: BioAlliance Pharma (Paris, FR)
Application Number:13/565,653
Patent Claims: 1. A prolonged release mucoadhesive formulation comprising: an antiviral agent selected from acyclovir, valacyclovir, gancyclovir, and zidovudin; a diluent; an alkali metal alkyl sulfate; a binding agent; at least one bioadhesive polymer that allows the formulation to adhere to the oral mucosa following administration to a human patient; and at least one sustained release polymer; wherein the formulation is configured to release the antiviral agent to the oral mucosa from 30 minutes to at least 15 hours following administration; wherein the formulation comprises primary granules which comprise the antiviral agent, the diluent, the alkali metal alkylsulfate, and the binding agent; and wherein the bioadhesive polymer is dispersed in the formulation.

2. The formulation of claim 1, which comprises no more than 5% by weight of a polyvinylpyrrolidone.

3. The formulation of claim 1, wherein the bioadhesive polymer is not in the primary granules.

4. The formulation of claim 2, wherein the bioadhesive polymer is not in the primary granules.

5. The formulation of claim 1 or claim 2, wherein the alkali metal alkyl sulfate is present in an amount between 2% to 6% by weight.

6. The formulation of claim 1 or claim 2, wherein the binding agent is in an amount between 0.5% and 5% by weight.

7. The formulation of claim 1 or claim 2, which comprises between 0.5% and 5% by weight of a polyvinylpyrrolidone.

8. The formulation of claim 1 or claim 2, wherein the bioadhesive polymer is natural proteins.

9. The formulation of claim 8, wherein the natural proteins are natural milk proteins.

10. The formulation of claim 1 or claim 2, wherein said antiviral agent is acyclovir.

11. The formulation of claim 10, which is capable of delivering the acyclovir to the oral mucosa for a period of at least 20 hours.

12. The formulation of claim 10, wherein the acyclovir is in an amount between 50 mg and 100 mg.

13. The formulation of claim 1 or claim 2, which comprises: 10 mg to 200 mg of acyclovir, 1% to 75% by weight of microcrystalline cellulose, 2% to 10% by weight of sodium lauryl sulfate, 0.5% to 5% by weight of a polyvinylpyrrolidone, 10% to 40% by weight of at least one bioadhesive polymer selected from natural milk proteins and mixtures thereof, and 10% to 40% by weight of hypromellose.

14. The formulation of claim 1 or claim 2, which comprises 50 mg or 100 mg acyclovir and following administration to the oral mucosa provides a salivary concentration of acyclovir that is greater than 22.5 ng/ml for 36 hours.

15. A method of treating a mucosal disease, comprising administering to the oral mucosal of a human patient in need thereof the formulation of any one of claim 1 or claim 2.

16. The formulation of claim 1, wherein the formulation is devoid of starch.

17. The formulation of claim 2, wherein the formulation is devoid of starch.

18. The formulation of claim 1, wherein the predominant fraction of primary granules has a diameter of less than 125 .mu.m.

19. The formulation of claim 2, wherein the predominant fraction of primary granules has a diameter of less than 125 .mu.m.

20. The formulation of claim 1, wherein the at least one bioadhesive polymer is present in 10% to 40% by weight of the formulation.

21. The formulation of claim 2, wherein the at least one bioadhesive polymer is present in 10% to 40% by weight of the formulation.

22. The formulation of claim 20 or claim 21, wherein the bioadhesive polymer is natural proteins.

23. The formulation of claim 22, wherein the natural proteins are natural milk proteins.

24. The prolonged release mucoadhesive formulation of claim 1 comprising: 15% by weight microcrystalline cellulose; 4.5% by weight sodium lauryl sulfate; 0.4% by weight polyvinylpyrrolidone; 20% of at least one bioadhesive polymer selected from milk protein concentrate, pea protein, carbopol 974, and chitosan; 15% hypromellose; 1% magnesium stearate; 0.4% colloidal silica; and 50 mg of acyclovir.

25. The formulation of claim 24, wherein the bioadhesive polymer is milk protein concentrate.

26. The prolonged release mucoadhesive formulation of claim 1 comprising: 15% by weight microcrystalline cellulose; 4.5% by weight sodium lauryl sulfate; 0.4% by weight polyvinylpyrrolidone; 20% milk protein concentrate; 15% hypromellose; 1% magnesium stearate; 0.4% colloidal silica; and 100 mg of acyclovir.

27. A method of treating a mucosal disease, comprising administering to tho oral mucosal of a human patient in need thereof the formulation of claim 5.

28. A method of treating a mucosal disease, comprising administering to the oral mucosal of a human patient in need thereof the formulation of claim 10.
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