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Claims for Patent: 6,828,339

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Claims for Patent: 6,828,339

Title: Amlodipine salt forms and processes for preparing them
Abstract:Amlodipine besylate forms are described, including amlodipine besylate hydrates and novel amlodipine besylate anhydrates. A method of making various amlodipine besylate forms from an aqueous medium as well as the use of the same as a calcium channel blocker are described.
Inventor(s): Ettema; Gerrit J. B. (Nijmegen, NL), Hoorn; Hans (Nijmegen, NL), Lemmens; Jacobus M. (Nijmegen, NL)
Assignee: Synthon BV (Nijmegen, NL)
Application Number:10/300,003
Patent Claims: 1. A crystalline amlodipine besylate monohydrate.

2. The amlodipine besylate monohydrate according to claim 1, having a melting point on differential scanning calorimetry (DSC) within the range of 92-104.degree.C.

3. The amlodipine besylate monohydrate according to claim 1, having a purity of at least 99%.

4. The amlodipine besylate monohydrate according to claim 1, which exhibits an IR spetra corresponding to FIG. 6.

5. The amlodipine besylate monohydrate according to claim 1, which exhibits an x-ray powder diffraction pattern corresponding to FIG. 9C.

6. The amlodipine besylate monohydrate according to claim 1, which is in the form of particles having an average particle size of 100 microns or less.

7. The amlodipine besylate monohydrate according to claim 6, wherein said particles have an average particle size of 50 microns or less.

8. The amlodipine besylate monohydrate according to claim 7, which is in the form of particles having an average particle size of 10 microns or less.

9. A pharmaceutical composition comprising 1 to 20 mg of crystalline amlodipine besylate monohydrate, microcrystalline cellulose, sodium starch glycollate, and magnesium stearate.

10. The pharmaceutical composition according to claim 9, which is in the form of a tablet.

11. The pharmaceutical composition according to claim 10, which consists essentially of crystalline amlodipine besylate monohydrate, microcrystalline cellulose, sodium starch glycollate, and magnesium stearate.

12. The pharmaceutical composition according to claim 11, wherein said crystalline amlodipine besylate monohydrate exhibits an JR spectra corresponding to FIG. 6.

13. The pharmaceutical composition according to claim 11, wherein said crystalline amlodipine besylate monohydrate exhibits an x-ray powder diffraction pattern corresponding to FIG. 9C.

14. The pharmaceutical composition according to claim 11, wherein said crystalline amlodipine besylate monohydrate are particles having an average particle size of 50 microns or less.

15. The pharmaceutical composition according to claim 11, wherein said crystalline amlodipine besylate monohydrate are particles having an average particle size of 10 microns or less.
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