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Claims for Patent: 6,106,864

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Claims for Patent: 6,106,864

Title: Pharmaceutical formulations containing darifenacin
Abstract:There is provided a pharmaceutical dosage form adapted for administration to the gastrointestinal tract of a patient, comprising darifenacin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable adjuvant, diluent or carrier, characterized in that the dosage form is adapted to deliver at least 10% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, to the lower gastrointestinal tract of the patient. The formulation minimizes unwanted side-effects and increases the bioavailability of darifenacin.
Inventor(s): Dolan; Thomas Francis (Sandwich, GB), Humphrey; Michael John (Sandwich, GB), Nichols; Donald John (Sandwich, GB)
Assignee: Pfizer Inc. (New York, NY)
Application Number:09/029,072
Patent Claims: 1. A pharmaceutical dosage form adapted for administration to the gastrointestinal tract of a patient, comprising darifenacin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable adjuvant, diluent, or carrier; characterized in that the dosage form is adapted to release in the lower gastrointestinal tract at least 10% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof.

2. A dosage form as claimed in claim 1, which is adapted to release at least 50% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, to the lower gastrointestinal tract.

3. A dosage form as claimed in claim 1, which is adapted to release the darifenacin, or the pharmaceutically acceptable salt thereof, to the gastrointestinal tract of the patient over or after a sustained period of time following administration of the dosage form to the patient.

4. A dosage form as claimed in claim 3, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released 4 hours after dosing.

5. A dosage form as claimed in claim 4, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released 8 hours after dosing.

6. A dosage form as claimed in claim 5, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released 16 hours after dosing.

7. A dosage form as claimed in claim 1, wherein the darifenacin is in the form of its hydrobromide salt.

8. A dosage form as claimed in claim 1, which is adapted for oral administration.

9. A dosage form as claimed in claim 1, wherein the darifenacin, or the pharmaceutically acceptable salt thereof, is embedded in a matrix from which it is released by diffusion.

10. A dosage form as claimed in claim 9, wherein the matrix material is high molecular weight hydroxypropyl methylcellulose.

11. A dosage form as claimed in claim 1, which is adapted for rectal administration.

12. A dosage form as claimed in claim 11, which is a suppository.

13. A dosage form as claimed in claim 1, which is adapted to release at least 25% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, to the lower gastrointestinal tract.

14. A dosage form as defined in claim 1, comprising darifenacin hydrobromide, anhydrous dibasic calcium phosphate, hydroxypropyl methylcellulose, and magnesium stearate.

15. A dosage form as defined in claim 14, wherein said hydroxypropyl methycellulose has a number average molecular weight of 89,000, a methoxy content of 19-24%, and a hydroxypropoxy content of 7-12%.

16. A pharmaceutical dosage form adapted for administration to the gastrointestinal tract of a patient, comprising darifenacin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable adjuvant, diluent or carrier; characterized in that the dosage form is adapted to release the darifenacin, or the pharmaceutically acceptable salt thereof, in Apparatus 1 described in USP XXII at page 1578, having baskets of 40 mesh (381 .mu.m apertures), a rotation speed of 100 rpm and a dissolution medium of water 37.degree. C., over a sustained period of time.

17. A dosage form as claimed in claim 16, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released after 4 hours.

18. A dosage form as claimed in claim 16, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released after 8 hours.

19. A dosage form as claimed in claim 16, wherein no more than 90% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, is released after 16 hours.

20. A dosage form as claimed in claim 16, wherein the darifenacin is in the form of its hydrobromide salt.

21. A dosage form as claimed in claim 16, which is adapted for oral administration.

22. A dosage form as claimed in claim 16, wherein the darifenacin, or the pharmaceutically acceptable salt thereof, is embedded in a matrix from which it is released by diffusion.

23. A dosage form as claimed in claim 22, wherein the matrix material is high molecular weight hydroxypropyl methylcellulose.

24. A dosage form as claimed in claim 16, which is adapted for rectal administration.

25. A dosage form as claimed in claim 24, which is a suppository.

26. A method of treatment of irritable bowel syndrome or urinary incontinence, which comprises administering darifenacin, or a pharmaceutically acceptable salt thereof, to the lower gastrointestinal tract of a patient in need of such treatment.

27. A method as claimed in claim 26, which comprises administering a dosage form as defined in claim 1 to the gastrointestinal tract of a patient in need of such treatment.

28. A method as claimed in claim 26, which comprises administering a dosage form as defined in claim 16 to the gastrointestinal tract of a patient in need of such treatment.
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