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Last Updated: October 22, 2019

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Claims for Patent: 9,526,703

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Summary for Patent: 9,526,703
Title:Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract: A solid oral dosage form comprising a core comprising a doxylamine component and a pyridoxine component coated with an enteric coating is disclosed. The solid oral dosage form further comprises two active ingredient-containing coatings surrounding the enteric coating, the active ingredient-containing coatings being separated from one another by an intermediate coating, and one of the two active ingredient-containing coatings comprising a doxylamine component and being free of a pyridoxine component, and the other of the two active ingredient-containing coatings comprising a pyridoxine component and being free of doxylamine component. Uses of the solid oral dosage form for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting of pregnancy (NVP), are also disclosed.
Inventor(s): Vranderick; Manon (St-Lazare, CA), St-Onge; Jean-Luc (Mirabel, CA), Gallo; Michele (Blainville, CA), Gervais; Eric (Blainville, CA)
Assignee: Duchesnay Inc. (Blainville, CA)
Application Number:14/839,859
Patent Claims: 1. A solid oral dosage form comprising: (I) a delayed release component comprising: (a) a core comprising from about 5 mg to about 40 mg of doxylamine and/or a pharmaceutically acceptable salt thereof and from about 5 mg to about 40 mg of pyridoxine and/or a pharmaceutically acceptable salt thereof; and (b) an enteric coating surrounding said core; and (II) an immediate release component comprising: (c) a first active ingredient-containing immediate release coating surrounding said enteric coating and comprising (i) from about 5 mg to about 40 mg of doxylamine and/or a pharmaceutically acceptable salt thereof, or (ii) from about 5 mg to about 40 mg of pyridoxine and/or a pharmaceutically acceptable salt thereof; and (d) a second active ingredient-containing immediate release coating surrounding said first active ingredient-containing coating and comprising (i) from about 5 mg to about 40 mg of doxylamine and/or a pharmaceutically acceptable salt thereof, or (ii) from about 5 mg to about 40 mg of pyridoxine and/or a pharmaceutically acceptable salt thereof; wherein if said first active ingredient-containing immediate release coating comprises said doxylamine and/or pharmaceutically acceptable salt thereof, said second active ingredient-containing immediate release coating comprises said pyridoxine and/or pharmaceutically acceptable salt thereof, and if said first active ingredient-containing immediate release coating comprises said pyridoxine and/or pharmaceutically acceptable salt thereof, said second active ingredient-containing immediate release coating comprises said doxylamine and/or pharmaceutically acceptable salt thereof.

2. The solid oral dosage form of claim 1, wherein said core comprises about 10 mg of said doxylamine or pharmaceutically acceptable salt thereof.

3. The solid oral dosage form of claim 1, wherein said core comprises doxylamine succinate.

4. The solid oral dosage form of claim 1, wherein said core comprises about 10 mg of said pyridoxine or pharmaceutically acceptable salt thereof.

5. The solid oral dosage form of claim 1, wherein said core comprises pyridoxine hydrochloride.

6. The solid oral dosage form of claim 1, wherein said first or second active ingredient-containing immediate release coating comprises about 10 mg of said doxylamine or pharmaceutically acceptable salt thereof.

7. The solid oral dosage form of claim 1, wherein said first or second active ingredient-containing immediate release coating comprises doxylamine succinate.

8. The solid oral dosage form of claim 1, wherein said first or second active ingredient-containing immediate release coating comprises about 10 mg of said pyridoxine or pharmaceutically acceptable salt thereof.

9. The solid oral dosage form of claim 1, wherein said first or second active ingredient-containing immediate release coating comprises pyridoxine hydrochloride.

10. The solid oral dosage form of claim 1, wherein said first and/or second active ingredient-containing immediate release coating comprises an immediate release film coating system.

11. The solid oral dosage form of claim 1, wherein said core is present in an amount of about 50% to about 70% (w/w) of said solid oral dosage form.

12. The solid oral dosage form of claim 1, wherein said enteric coating is present in an amount of about 2% to about 15% (w/w) of said solid oral dosage form.

13. The solid oral dosage form of claim 1, wherein said enteric coating comprises an acrylic polymer or co-polymer.

14. The solid oral dosage form of claim 13, wherein said acrylic polymer or co-polymer is a copolymer based on methacrylic acid and ethyl acrylate.

15. The solid oral dosage form of claim 1, wherein said first active ingredient-containing immediate release coating is present in an amount of about 4% to about 12% (w/w) in said solid oral dosage form.

16. The solid oral dosage form of claim 1, further comprising a first intermediate coating surrounding said first active ingredient-containing immediate release coating.

17. The solid oral dosage form of claim 16, wherein said first intermediate coating is present in an amount of about 1% to about 4% (w/w) in said solid oral dosage form.

18. The solid oral dosage form of claim 16, wherein said first intermediate coating comprises a film coating system.

19. The solid oral dosage form of claim 1, wherein said second active ingredient-containing immediate release coating is present in an amount of about 5% to about 15% (w/w) of said solid oral dosage form.

20. The solid oral dosage form of claim 1, further comprising a second intermediate coating between said core and said enteric coating.

21. The solid oral dosage form of claim 1, further comprising a third intermediate coating between said enteric coating and said first active ingredient-containing immediate release coating.

22. The solid oral dosage form of claim 1, further comprising a seal coating surrounding said second active ingredient-containing immediate release coating.

23. The solid oral dosage form of claim 22, wherein said seal coating is present in an amount of about 2% to about 10% (w/w) of said solid oral dosage form.

24. The solid oral dosage form of claim 22, wherein said seal coating comprises a film coating system.

25. The solid oral dosage form of claim 22, further comprising a solid oral dosage form-coating agent surrounding said seal coating.

26. The solid oral dosage form of claim 25, wherein said solid oral dosage form-coating agent is present in an amount of about 0.005% to about 0.5% (w/w) of said solid oral dosage form.

27. The solid oral dosage form of claim 25, wherein said solid oral dosage form-coating agent comprises wax.

28. The solid oral dosage form of claim 1, wherein said solid oral dosage form is a tablet.

29. A solid oral dosage form comprising: (I) a delayed release component comprising: (a) a core comprising about 10 mg of doxylamine succinate and about 10 mg of pyridoxine hydrochloride; (b) a second intermediate coating surrounding said core; (c) an enteric coating surrounding said second intermediate coating; and (d) a third intermediate coating surrounding said enteric coating; and (II) an immediate release component comprising: (e) a first active ingredient-containing immediate release coating surrounding said third intermediate coating and comprising about 10 mg of pyridoxine hydrochloride; (f) a first intermediate coating surrounding said first active ingredient-containing immediate release coating; (g) a second active ingredient-containing immediate release coating surrounding said first intermediate coating and comprising about 10 mg of doxylamine succinate; (h) a seal coating surrounding said second active ingredient-containing immediate release coating; and (i) a solid oral dosage form-coating agent surrounding said seal coating.

30. A method for alleviating the symptoms of nausea and vomiting of human pregnancy, said method comprising administering the solid oral dosage form of claim 1 to a pregnant human female in need thereof.

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