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Claims for Patent: 8,604,064

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Claims for Patent: 8,604,064

Title:Process for the preparation of roflumilast
Abstract: A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.
Inventor(s): Kohl; Bernhard (Constance, DE), Mueller; Bernd (Constance, DE), Palosch; Walter (Rielasingen, DE)
Assignee: Takeda GmbH (Constance, DE)
Application Number:13/860,248
Patent Claims: 1. A method for the treatment of an acute or chronic airway disorder comprising: administering to a patient suffering from an acute or chronic airway disorder, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.

2. The method of claim 1, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

3. The method of claim 1, wherein said N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide is present (relative to roflumilast) in an amount greater than zero and less than 0.05% by weight.

4. A method for the treatment of an acute or chronic airway disorder comprising: administering to a patient suffering from an acute or chronic airway disorder, a therapeutically effective amount of a pharmaceutical composition, comprising: roflumilast having a purity of greater than or equal to 99% by weight; N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight; and pharmaceutically acceptable auxiliaries and/or excipients.

5. The method of claim 4, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

6. The method of claim 4, wherein said N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide is present (relative to roflumilast) in an amount greater than zero and less than 0.05% by weight.

7. A method for the treatment of an acute or chronic airway disorder comprising: administering to a patient suffering from an acute or chronic airway disorder, a therapeutically effective amount of a pharmaceutical dosage form, comprising: roflumilast having a purity of greater than or equal to 99% by weight; N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight; and pharmaceutically acceptable auxiliaries and/or excipients.

8. The method of claim 7, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

9. The method of claim 7, wherein said N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide is present (relative to roflumilast) in an amount greater than zero and less than 0.05% by weight.

10. The method of claim 7, wherein said pharmaceutical dosage form is selected from the group consisting of tablets, coated tablets, capsules, caplets, suppositories, emulsions, suspensions, gels and solutions.

11. The method of claim 7, wherein said pharmaceutical dosage form includes from between 0.1% and 95% roflumilast.

12. The method of claim 7, wherein the pharmaceutical dosage form is an oral dosage form.

13. The method of claim 7, wherein the pharmaceutical dosage form contains from 0.05 mg to 2.5 mg of roflumilast.

14. The method of claim 13, wherein the pharmaceutical dosage form contains from 0.1 to 0.5 mg of roflumilast.

15. The method of claim 14, wherein the pharmaceutical dosage form contains 0.25 mg of roflumilast.

16. The method of claim 14, wherein the pharmaceutical dosage form contains 0.5 mg of roflumilast.

17. A method for the treatment of an acute or chronic airway disorder comprising: administering to a patient suffering from an acute or chronic airway disorder, a therapeutically effective amount of a pharmaceutical tablet, comprising: 0.5 mg of roflumilast having a purity of greater than or equal to 99% by weight; N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount less than 0.1% by weight; and pharmaceutically acceptable auxiliaries and/or excipients.

18. The method of claim 17, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

19. The method of claim 17, wherein said N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide is present (relative to roflumilast) in an amount greater than zero and less than 0.05% by weight.

20. The method of claim 1, wherein said disorder is selected from the group consisting of asthma, bronchitis, allergic rhinitis, emphysema and chronic obstructive pulmonary disease.

21. The method of claim 4, wherein said disorder is selected from the group consisting of asthma, bronchitis, allergic rhinitis, emphysema and chronic obstructive pulmonary disease.

22. The method of claim 7, wherein said disorder is selected from the group consisting of asthma, bronchitis, allergic rhinitis, emphysema and chronic obstructive pulmonary disease.

23. The method of claim 17, wherein said disorder is selected from the group consisting of asthma, bronchitis, allergic rhinitis, emphysema and chronic obstructive pulmonary disease.
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