Process for the preparation of roflumilast
DCFirst Claim
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1. 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.
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Abstract
The invention relates to novel processes for the preparation of high-purity roflumilast.
156 Citations
29 Claims
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1. 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 (2, 3, 4, 5)
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6. 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 (7, 8)
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9. 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 (10, 11, 12, 13)
- administering to a patient suffering from chronic obstructive pulmonary disease a therapeutically effective amount of a pharmaceutical composition, comprising;
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14. 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 (15, 16)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical composition, comprising;
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17. 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 (18, 19, 20, 21, 22, 23, 24, 25, 26)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical dosage form, comprising;
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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 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 (28, 29)
- administering to a patient suffering from chronic obstructive pulmonary disease, a therapeutically effective amount of a pharmaceutical tablet, comprising;
Specification