NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST
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Abstract
The invention relates to novel processes for the preparation of high-purity roflumilast.
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50 Claims
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1-21. -21. (canceled)
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22. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide and a therapeutically effective amount of roflumilast.
- View Dependent Claims (23, 24, 25, 26)
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27. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease, 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.
- View Dependent Claims (28, 29)
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30. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease a therapeutically effective amount of a pharmaceutical composition, comprising;
roflumilast;
N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide; and
pharmaceutically acceptable auxiliaries and/or excipients. - View Dependent Claims (31, 32, 33, 34)
- administering to a patient suffering from chronic obstructive pulmonary disease a therapeutically effective amount of a pharmaceutical composition, comprising;
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35. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease, 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. - View Dependent Claims (36, 37)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical composition, comprising;
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38. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease, 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. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical dosage form, comprising;
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48. A method for the treatment of chronic obstructive pulmonary disease, comprising:
- administering to a patient suffering from chronic obstructive pulmonary disease, 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. - View Dependent Claims (49, 50)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical tablet, comprising;
Specification