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Claims for Patent: 8,618,142

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Claims for Patent: 8,618,142

Title:Process for the preparation of roflumilast
Abstract: A composition comprising: 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:13/860,264
Patent Claims: 1. A composition comprising: 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 composition of claim 1, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

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

6. The pharmaceutical composition 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 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 pharmaceutical dosage form of claim 7, wherein said roflumilast has a purity of greater than or equal to 99.8% by weight.

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

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

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

13. The oral dosage form of claim 12, containing from 0.05 mg to 2.5 mg of roflumilast.

14. The oral dosage form of claim 13, containing from 0.1 to 0.5 mg of roflumilast.

15. The oral dosage form of claim 14, containing 0.25 mg of roflumilast.

16. The oral dosage form of claim 14, containing 0.5 mg of roflumilast.

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

19. The pharmaceutical tablet 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.
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