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Details for Patent: 8,211,466

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Details for Patent: 8,211,466

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)
Filing Date:Feb 17, 2010
Application Number:12/707,369
Claims:1. A mucosal bioadhesive slow release carrier formulation comprising (I) at least one antiviral agent, wherein said antiviral agent is: (i) valacyclovir, gancyclovir and zidovudine in an amount of 10 mg to 200 mg, or (ii) acyclovir in an amount of 10 mg to 500 mg; (II) 1% to 75% by weight of microcrystalline cellulose; (III) 2% to 10% by weight of sodium lauryl sulphate; (IV) 0.5% to 5% by weight of polyvinylpyrrolidone; (V) 10% to 40% by weight of natural milk proteins; and (VI) 10% to 40% by weight of hypromellose, said mucosal bioadhesive slow release carrier formulation being obtained by a process comprising the steps of: (a) mixing said at least one antiviral agent with said sodium lauryl sulfate and said microcrystalline cellulose, thereby producing a mixture; (b) wetting said mixture of (a) with said polyvinylpyrrolidone; (c) drying and calibrating said mixture of (b); (d) granulating said mixture of (c) to form primary granules; (e) blending said primary granules with said natural milk proteins and said hypromellose and at least one compression agent; and (f) compressing said blended granules of (e).

2. The mucosal bioadhesive slow release carrier formulation according to claim 1, in which said antiviral agent is acyclovir in an amount of 10 mg to 500 mg.

3. The mucosal bioadhesive slow release carrier formulation according to claim 2 in which said acyclovir is present in an amount from 10 mg to 200 mg.

4. The mucosal bioadhesive slow release carrier formulation according to claim 2, in which said acyclovir is present in an amount from 50 mg to 100 mg.

5. The mucosal bioadhesive slow release carrier formulation according to claim 2, which is devoid of lactose and of corn starch.

6. The mucosal bioadhesive slow release carrier formulation according to claim 1, which further comprises a second active principle selected from: an antiviral, an antifungal, an analgesic, an anaesthetic, an antalgic, an antiemetic, a salivation agent, an antiseptic, an anti-inflammatory, an antibiotic and mixtures thereof.

7. A method of treating a viral mucosal disease, selected from orofacial herpes, herpes simplex complex 1 (HSV-1) infection, genital herpes (HSV-2) infection, and oral hairy leukoplakia comprising: administering to a patient in need thereof a therapeutically effective amount of the mucosal bioadhesive slow release carrier formulation of claim 1.

8. The method of claim 7, wherein the viral mucosal disease is a buccal disease.

9. A method of treating a viral infection, wherein said virus is selected from herpes simplex complex 1 (HSV-1), genital herpes (HSV-2), varicella zoster virus (VZV), Epstein-Barr virus, human herpes virus 8, avian influenza, mumps, HIV, respiratory syncitial virus, influenza virus, parainfluenza virus and cytomegalovirus, comprising: administering to a patient in need thereof a therapeutically effective amount of the mucosal bioadhesive slow release carrier formulation of claim 1.

10. A method for preparing a mucosal bioadhesive slow release carrier formulation according to claim 1, the method comprising: (a) mixing at least one antiviral agent with sodium lauryl sulphate and microcrystalline cellulose, thereby producing a mixture; (b) wetting said mixture of (a) with polyvinylpyrrolidone; (c) drying and calibrating said mixture of (b); (d) granulating said mixture of (c) to form primary granules; (e) blending said primary granules with natural milk proteins and hypromellose and at least one compression agent; and (f) compressing said blended granules of (e).

11. The method according to claim 10, wherein a second active principle selected from: an antiviral, an antifungal, an analgesic, an anaesthetic, an antalgic, an antiemetic, a salivation agent, an antiseptic, an anti-inflammatory, an antibiotic and mixtures thereof, is mixed with said antiviral agent, sodium lauryl sulphate, and microcrystalline cellulose in step (a).
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