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Claims for Patent: 8,119,158

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Claims for Patent: 8,119,158

Title:Effervescent oral fentanyl dosage form and methods of administering fentanyl
Abstract: Fentanyl-containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than known oral formulation and have advantages in terms of reduced cost and reduced side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
Inventor(s): Moe; Derek (Maple Grove, MN), Agarwal; Vikas (Plymouth, MN), Habib; Walib (Crystal, MN)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:12/955,346
Patent Claims: 1. A dosage form comprising: from about 200 micrograms to about 800 micrograms of fentanyl, a salt form of fentanyl, or combinations thereof, calculated as fentanyl free base; an effervescent material in an amount of about 15% to no more than about 60% by weight of the dosage form; a pH adjusting substance in an amount of about 0.5 to about 25% by weight of the dosage form, wherein said pH adjusting substance is not a component of said effervescent material; mannitol in an amount of between about 10 and about 80% by weight of the dosage form; a starch glycolate in an amount of about 0.25 to about 20% by weight of the dosage form; wherein said dosage form is suitable for delivery of said fentanyl across the oral mucosa of a patient by buccal, gingival or sublingual administration.

2. The dosage form of claim 1 wherein said pH adjusting substance is selected and provided in an amount capable of providing a change in localized pH of at least 0.5 pH units.

3. The dosage form of claim 2 wherein said pH adjusting substance is a carbonate, phosphate or bicarbonate.

4. The dosage form of claim 1 being a compressed tablet.

5. A dosage form comprising: from about 200 micrograms to about 800 micrograms of fentanyl, a salt form of fentanyl, or combinations thereof, calculated as fentanyl free base; an effervescent material in an amount of about 15% to no more than about 60% by weight of the dosage form; a pH adjusting substance, said adjusting substance selected and provided in an amount capable of providing a change in localized pH of at least 0.5 pH units, wherein said pH adjusting substance is not a component of said effervescent material; mannitol in an amount of between about 10 and about 80% by weight of the dosage form and; a starch glycolate; wherein said dosage form is adapted for delivery of said fentanyl across the oral mucosa of a patient by buccal, gingival or sublingual administration.

6. The dosage form of claim 5 wherein said pH adjusting substance is present in an amount of about 0.5 to about 25% by weight of said dosage form, and said starch glycolate is present in an amount of about 0.25 to about 20% by weight of the dosage form.

7. The dosage form of claim 6 wherein said pH adjusting substance is present in an amount of about 2 to about 20% by weight of said dosage form, and said starch glycolate is present in an amount of about 0.5 to about 15% by weight of the dosage form.

8. A method of treating pain in a patient in need thereof comprising the steps of: placing a dosage form according to claim 7 into the mouth of a patient in contact with said patient's oral mucosa, and maintaining said dosage form in intimate contact with said oral mucosa for a time sufficient to deliver a therapeutically effective amount of said fentanyl across said oral mucosa.

9. The method of claim 8 wherein said dosage form is held in contact with said oral mucosa for a period of between about 10 and about 30 minutes.

10. The method of claim 9 wherein said dosage form is held in contact with said oral mucosa for a period of time sufficient to provide absorption of at least about 75% of said fentanyl dose into the blood stream of said patient.

11. The method of claim 8, wherein said pain is selected from the group consisting of back pain, breakthrough cancer pain, neuropathic pain, surgical pain and postoperative pain.

12. A method of making a dosage form according to claim 7 in the form of a tablet for buccal, gingival or sublingual administration of fentanyl comprising the steps of: providing said fentanyl or a salt thereof in an amount of about 200 micrograms to about 800 micrograms per dose measured as fentanyl base, or an equivalent amount of a salt thereof, providing said effervescent couple in an amount of about 5 to about 85% by weight of the dosage form, said pH adjusting substance in an amount of about 0.5 to about 25% by weight of the dosage form, and said starch glycolate in an amount of about 0.25 to about 20% by weight of the dosage, blending said fentanyl, effervescent couple, pH adjusting substance and said starch glycolate, and compressing the resulting blend into at least one tablet.

13. The method of claim 12 further comprising the step of packaging said tablet in an F1 package.

14. The method of claim 12 further comprising the step of providing a filler in an amount of about 10 and about 80% by weight of the dosage form and blending same with said fentanyl, effervescent couple, pH adjusting substance and said starch glycolate prior to compressing the resulting blend into at least one tablet.

15. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 200 micrograms.

16. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 300 micrograms.

17. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 400 micrograms.

18. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 500 micrograms.

19. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 600 micrograms.

20. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 700 micrograms.

21. The dosage form of claim 1, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 800 micrograms.

22. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 200 micrograms.

23. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 300 micrograms.

24. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 400 micrograms.

25. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 500 micrograms.

26. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 600 micrograms.

27. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 700 micrograms.

28. The dosage form of claim 5, wherein the fentanyl, salt form of fentanyl, or combinations thereof, calculated as a fentanyl free base is about 800 micrograms.
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