PHARMACEUTICAL DRY POWDER INHALATION FORMULATION
The present invention relates to pharmaceutical dry powder formulations, comprising (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid of formula (I), preferably in form of one of its salt...
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Format | Patent |
Language | English French |
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06.07.2023
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Abstract | The present invention relates to pharmaceutical dry powder formulations, comprising (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid of formula (I), preferably in form of one of its salts or solvates or hydrates, preferably (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (I) of formula (I-M-I) or (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (II) of formula (I-M-II) in combination with a lactose carrier, comprising lactose monohydrate as a mixture of coarse lactose and fine lactose, and to the process of manufacturing such pharmaceutical dry powder formulations and its application for use in the treatment of cardiopulmonary disorders, such as pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary hypertension (PH) associated with chronic lung disease (PH group 3) such as pulmonary hypertension in chronic obstructive pulmonary disease (PH-COPD) and pulmonary hypertension with idiopathic interstitial pneumonia (PH-IIP).
La présente invention concerne des formulations pharmaceutiques de poudre sèche comprenant un acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7,8-tétrahydroquinoline-2-carboxylique de formule (I), de préférence sous la forme d'un de ses sels, solvates ou hydrates, de préférence un monohydrate d'acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7, 8-tétrahydroquinoline-2-carboxylique de formule (I-M-I) ou un monohydrate d'acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7, 8-tétrahydroquinoline-2-carboxylique de formule (I-M-II) en combinaison avec un support de lactose, comprenant un monohydrate de lactose en tant que mélange de lactose grossier et de lactose fin, ainsi que le procédé de fabrication de telles formulations pharmaceutiques de poudre sèche et leur application destinée à être utilisée dans le traitement des troubles cardio-pulmonaires, tels que l'hypertension artérielle pulmonaire (HTAP), l'hypertension pulmonaire thromboembolique chronique (HTPC) et l'hypertension pulmonaire (PH) associée à une maladie pulmonaire chronique (groupe 3) telle que l'hypertension pulmonaire dans la maladie pulmonaire obstructive chronique (PH-COPD) et l'hypertension pulmonaire dans la pneumonie interstitielle idiopathique (PH-IIP). |
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AbstractList | The present invention relates to pharmaceutical dry powder formulations, comprising (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid of formula (I), preferably in form of one of its salts or solvates or hydrates, preferably (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (I) of formula (I-M-I) or (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (II) of formula (I-M-II) in combination with a lactose carrier, comprising lactose monohydrate as a mixture of coarse lactose and fine lactose, and to the process of manufacturing such pharmaceutical dry powder formulations and its application for use in the treatment of cardiopulmonary disorders, such as pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary hypertension (PH) associated with chronic lung disease (PH group 3) such as pulmonary hypertension in chronic obstructive pulmonary disease (PH-COPD) and pulmonary hypertension with idiopathic interstitial pneumonia (PH-IIP).
La présente invention concerne des formulations pharmaceutiques de poudre sèche comprenant un acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7,8-tétrahydroquinoline-2-carboxylique de formule (I), de préférence sous la forme d'un de ses sels, solvates ou hydrates, de préférence un monohydrate d'acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7, 8-tétrahydroquinoline-2-carboxylique de formule (I-M-I) ou un monohydrate d'acide (5S)-{[2-(4-carboxyphényl)éthyl][2-(2-{[3-chloro-4'-(trifluorométhyl)biphényl-4-yl]méthoxy}phényl)éthyl]-amino}-5,6,7, 8-tétrahydroquinoline-2-carboxylique de formule (I-M-II) en combinaison avec un support de lactose, comprenant un monohydrate de lactose en tant que mélange de lactose grossier et de lactose fin, ainsi que le procédé de fabrication de telles formulations pharmaceutiques de poudre sèche et leur application destinée à être utilisée dans le traitement des troubles cardio-pulmonaires, tels que l'hypertension artérielle pulmonaire (HTAP), l'hypertension pulmonaire thromboembolique chronique (HTPC) et l'hypertension pulmonaire (PH) associée à une maladie pulmonaire chronique (groupe 3) telle que l'hypertension pulmonaire dans la maladie pulmonaire obstructive chronique (PH-COPD) et l'hypertension pulmonaire dans la pneumonie interstitielle idiopathique (PH-IIP). |
Author | FABER, Helene EGGER, Julian LANG, Dieter MUNDRY, Tobias TINEL, Hanna RICHTER, Annett SCHIRMER, Heiko SALEH, Soundos FEY, Peter TEREBESI, Ildiko KEIL, Birgit OLENIK, Britta BECKER-PELSTER, Eva Maria HAHN, Michael VITRE, Cecile DIETZ, Lisa WARD, David NAGELSCHMITZ, Johannes JUNG, David PARRY, Mark RÖSLER, Bernd WEIMANN, Gerrit BECKER, Guido BOTHE, Clemens |
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Title | PHARMACEUTICAL DRY POWDER INHALATION FORMULATION |
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