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1. WO2013055302 - EFFERVESCENT COMPOSITION COMPRISING N-ACETYLCYSTEINE AND DOXOPHYLLINE OR THEOPHYLLINE

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[ EN ]

CLAIMS

1. An effervescent pharmaceutical composition comprising doxophylline or theophylline together with N- Acetylcysteine as active agents.

2. The pharmaceutical composition according to claim 1 characterized in that the active agents composing the composition is in free form or in the form of pharmaceutically acceptable salts, enantiomers, racemates, solvates, hydrates, different polymorphic forms and amorphous forms of related active agents.

3. The pharmaceutical composition according to claim 1 characterized in that said composition comprises NAC in the range of 1-50% by weight and doxophylline and/or theophylline in the range of 1-40% by weight.

4. The pharmaceutical composition according to claims 1-3 characterized in that said composition comprises at least one pharmaceutically acceptable sweetener, at least one flavouring agent, at least one binder, at least one solvent, at least one effervescent acid- base couple, at least one lubricant and optionally at least one other pharmaceutically acceptable excipient together with the active agents.

5. The pharmaceutical composition according to claim 4 characterized in that the ratio of effervescent acid to effervescent base in said compositions is in the range of 0.1 to 5 by weight.

6. The pharmaceutical composition according to claim 5 characterized in that the ratio of effervescent acid to effervescent base in said compositions is in the range of 0.1 to 4 by weight.

7. The pharmaceutical composition according to claim 6 characterized in that the ratio of effervescent acid to effervescent base in said compositions is in the range of 0.1 to 3 by weight.

8. A method for the production of the pharmaceutical composition according to any preceding claims characterized in that said method is wet-granulation method.

9. The method according to claim 8 characterized in that the mixture is wet-granulated after doxophylline or theophylline is mixed with at least one pharmaceutically acceptable effervescent acid and at least one effervescent base.

10. The method according to claim 9 characterized in that the mixture is wet-granulated after doxophylline or theophylline is mixed with at least one pharmaceutically acceptable effervescent acid and at least one effervescent base; and a pharmaceutically effective amount of NAC and optionally at least one pharmaceutically acceptable sweetener,

lubricant and flavouring agent are added to the obtained granules so as to obtain the final granules.

1 1. The method according to claims 8-10 characterized in that the pharmaceutically acceptable effervescent acid is citric acid or pharmaceutically acceptable derivative thereof; and effervescent base is sodium hydrogen carbonate.

12. The pharmaceutical composition according to claim 1 characterized in that said composition is used for expectorating and decreasing phlegm in respiratory tract diseases; chronic obstructive pulmonary disease (COPD), allergic rhinitis, acute or chronic bronchitis, catarrh and cold; in the cases that expectoration must be eased; and in treatment of pulmonary diseases, bronchopulmonary diseases, bronchial secretion disorders.