FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN
La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus s...
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| creator | PARRY, MARK WARD, DAVID RICHTER, ANNETT MUNDRY, TOBIAS BOTHE, CLEMENS OLENIK, BRITTA FABER, HELENE NAGELSCHMITZ, JOHANNES BECKER, GUIDO BECKER-PELSTER, EVA MARIA RSLER, BERND EGGER, JULIAN HAHN, MICHAEL FEY, PETER SCHIRMER, HEIKO KEIL, BIRGIT TEREBESI, ILDIKO LANG, DIETER JUNG, DAVID VITRE, CECILE TINEL, HANNA WEIMANN, GERRIT SALEH, SOUNDOS DIETZ, LISA |
| description | La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus sales o solvatos o hidratos, preferiblemente ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato I de fórmula (1-M-I) o ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato II de fórmula (1-M-II) en combinación con un portador de lactosa, que comprende lactosa monohidrato como mezcla de lactosa gruesa y lactosa fina, y al proceso de manufactura de dichas formulaciones farmacéuticas de polvo seco y su aplicación para usar en el tratamiento de trastornos cardiopulmonares, tales como hipertensión arterial pulmonar (PAH), hipertensión pulmonar tromboembólica crónica (CTEPH) e hipertensión pulmonar (PH) asociada con enfermedad pulmonar crónica (PH grupo 3) tal como hipertensión pulmonar en la enfermedad pulmonar obstructiva crónica (PH-EPOC) e hipertensión pulmonar con neumonía intersticial idiopática (PH-IIP).
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 di |
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| fullrecord | <record><control><sourceid>epo_EVB</sourceid><recordid>TN_cdi_epo_espacenet_AR128145A1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>AR128145A1</sourcerecordid><originalsourceid>FETCH-epo_espacenet_AR128145A13</originalsourceid><addsrcrecordid>eNrjZAh28w_yDfVxdPY8PNlPwc0xyNfR-XBnaIins6OCi6tCgL9PmL9CsKuzv0KAY5CjgqefhyNMcaRCQJC_s2uwP1hhkCtIAViGh4E1LTGnOJUXSnMzyLu5hjh76KYW5MenFhckJqfmpZbEOwYZGlkYmpg6GhoTVgEArUox1A</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>patent</recordtype></control><display><type>patent</type><title>FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN</title><source>esp@cenet</source><creator>PARRY, MARK ; WARD, DAVID ; RICHTER, ANNETT ; MUNDRY, TOBIAS ; BOTHE, CLEMENS ; OLENIK, BRITTA ; FABER, HELENE ; NAGELSCHMITZ, JOHANNES ; BECKER, GUIDO ; BECKER-PELSTER, EVA MARIA ; RSLER, BERND ; EGGER, JULIAN ; HAHN, MICHAEL ; FEY, PETER ; SCHIRMER, HEIKO ; KEIL, BIRGIT ; TEREBESI, ILDIKO ; LANG, DIETER ; JUNG, DAVID ; VITRE, CECILE ; TINEL, HANNA ; WEIMANN, GERRIT ; SALEH, SOUNDOS ; DIETZ, LISA</creator><creatorcontrib>PARRY, MARK ; WARD, DAVID ; RICHTER, ANNETT ; MUNDRY, TOBIAS ; BOTHE, CLEMENS ; OLENIK, BRITTA ; FABER, HELENE ; NAGELSCHMITZ, JOHANNES ; BECKER, GUIDO ; BECKER-PELSTER, EVA MARIA ; RSLER, BERND ; EGGER, JULIAN ; HAHN, MICHAEL ; FEY, PETER ; SCHIRMER, HEIKO ; KEIL, BIRGIT ; TEREBESI, ILDIKO ; LANG, DIETER ; JUNG, DAVID ; VITRE, CECILE ; TINEL, HANNA ; WEIMANN, GERRIT ; SALEH, SOUNDOS ; DIETZ, LISA</creatorcontrib><description>La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus sales o solvatos o hidratos, preferiblemente ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato I de fórmula (1-M-I) o ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato II de fórmula (1-M-II) en combinación con un portador de lactosa, que comprende lactosa monohidrato como mezcla de lactosa gruesa y lactosa fina, y al proceso de manufactura de dichas formulaciones farmacéuticas de polvo seco y su aplicación para usar en el tratamiento de trastornos cardiopulmonares, tales como hipertensión arterial pulmonar (PAH), hipertensión pulmonar tromboembólica crónica (CTEPH) e hipertensión pulmonar (PH) asociada con enfermedad pulmonar crónica (PH grupo 3) tal como hipertensión pulmonar en la enfermedad pulmonar obstructiva crónica (PH-EPOC) e hipertensión pulmonar con neumonía intersticial idiopática (PH-IIP).
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).</description><language>spa</language><subject>HUMAN NECESSITIES ; HYGIENE ; MEDICAL OR VETERINARY SCIENCE ; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES ; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS</subject><creationdate>2024</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20240327&DB=EPODOC&CC=AR&NR=128145A1$$EHTML$$P50$$Gepo$$Hfree_for_read</linktohtml><link.rule.ids>230,308,780,885,25562,76317</link.rule.ids><linktorsrc>$$Uhttps://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20240327&DB=EPODOC&CC=AR&NR=128145A1$$EView_record_in_European_Patent_Office$$FView_record_in_$$GEuropean_Patent_Office$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>PARRY, MARK</creatorcontrib><creatorcontrib>WARD, DAVID</creatorcontrib><creatorcontrib>RICHTER, ANNETT</creatorcontrib><creatorcontrib>MUNDRY, TOBIAS</creatorcontrib><creatorcontrib>BOTHE, CLEMENS</creatorcontrib><creatorcontrib>OLENIK, BRITTA</creatorcontrib><creatorcontrib>FABER, HELENE</creatorcontrib><creatorcontrib>NAGELSCHMITZ, JOHANNES</creatorcontrib><creatorcontrib>BECKER, GUIDO</creatorcontrib><creatorcontrib>BECKER-PELSTER, EVA MARIA</creatorcontrib><creatorcontrib>RSLER, BERND</creatorcontrib><creatorcontrib>EGGER, JULIAN</creatorcontrib><creatorcontrib>HAHN, MICHAEL</creatorcontrib><creatorcontrib>FEY, PETER</creatorcontrib><creatorcontrib>SCHIRMER, HEIKO</creatorcontrib><creatorcontrib>KEIL, BIRGIT</creatorcontrib><creatorcontrib>TEREBESI, ILDIKO</creatorcontrib><creatorcontrib>LANG, DIETER</creatorcontrib><creatorcontrib>JUNG, DAVID</creatorcontrib><creatorcontrib>VITRE, CECILE</creatorcontrib><creatorcontrib>TINEL, HANNA</creatorcontrib><creatorcontrib>WEIMANN, GERRIT</creatorcontrib><creatorcontrib>SALEH, SOUNDOS</creatorcontrib><creatorcontrib>DIETZ, LISA</creatorcontrib><title>FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN</title><description>La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus sales o solvatos o hidratos, preferiblemente ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato I de fórmula (1-M-I) o ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato II de fórmula (1-M-II) en combinación con un portador de lactosa, que comprende lactosa monohidrato como mezcla de lactosa gruesa y lactosa fina, y al proceso de manufactura de dichas formulaciones farmacéuticas de polvo seco y su aplicación para usar en el tratamiento de trastornos cardiopulmonares, tales como hipertensión arterial pulmonar (PAH), hipertensión pulmonar tromboembólica crónica (CTEPH) e hipertensión pulmonar (PH) asociada con enfermedad pulmonar crónica (PH grupo 3) tal como hipertensión pulmonar en la enfermedad pulmonar obstructiva crónica (PH-EPOC) e hipertensión pulmonar con neumonía intersticial idiopática (PH-IIP).
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).</description><subject>HUMAN NECESSITIES</subject><subject>HYGIENE</subject><subject>MEDICAL OR VETERINARY SCIENCE</subject><subject>PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES</subject><subject>SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS</subject><fulltext>true</fulltext><rsrctype>patent</rsrctype><creationdate>2024</creationdate><recordtype>patent</recordtype><sourceid>EVB</sourceid><recordid>eNrjZAh28w_yDfVxdPY8PNlPwc0xyNfR-XBnaIins6OCi6tCgL9PmL9CsKuzv0KAY5CjgqefhyNMcaRCQJC_s2uwP1hhkCtIAViGh4E1LTGnOJUXSnMzyLu5hjh76KYW5MenFhckJqfmpZbEOwYZGlkYmpg6GhoTVgEArUox1A</recordid><startdate>20240327</startdate><enddate>20240327</enddate><creator>PARRY, MARK</creator><creator>WARD, DAVID</creator><creator>RICHTER, ANNETT</creator><creator>MUNDRY, TOBIAS</creator><creator>BOTHE, CLEMENS</creator><creator>OLENIK, BRITTA</creator><creator>FABER, HELENE</creator><creator>NAGELSCHMITZ, JOHANNES</creator><creator>BECKER, GUIDO</creator><creator>BECKER-PELSTER, EVA MARIA</creator><creator>RSLER, BERND</creator><creator>EGGER, JULIAN</creator><creator>HAHN, MICHAEL</creator><creator>FEY, PETER</creator><creator>SCHIRMER, HEIKO</creator><creator>KEIL, BIRGIT</creator><creator>TEREBESI, ILDIKO</creator><creator>LANG, DIETER</creator><creator>JUNG, DAVID</creator><creator>VITRE, CECILE</creator><creator>TINEL, HANNA</creator><creator>WEIMANN, GERRIT</creator><creator>SALEH, SOUNDOS</creator><creator>DIETZ, LISA</creator><scope>EVB</scope></search><sort><creationdate>20240327</creationdate><title>FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN</title><author>PARRY, MARK ; WARD, DAVID ; RICHTER, ANNETT ; MUNDRY, TOBIAS ; BOTHE, CLEMENS ; OLENIK, BRITTA ; FABER, HELENE ; NAGELSCHMITZ, JOHANNES ; BECKER, GUIDO ; BECKER-PELSTER, EVA MARIA ; RSLER, BERND ; EGGER, JULIAN ; HAHN, MICHAEL ; FEY, PETER ; SCHIRMER, HEIKO ; KEIL, BIRGIT ; TEREBESI, ILDIKO ; LANG, DIETER ; JUNG, DAVID ; VITRE, CECILE ; TINEL, HANNA ; WEIMANN, GERRIT ; SALEH, SOUNDOS ; DIETZ, LISA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-epo_espacenet_AR128145A13</frbrgroupid><rsrctype>patents</rsrctype><prefilter>patents</prefilter><language>spa</language><creationdate>2024</creationdate><topic>HUMAN NECESSITIES</topic><topic>HYGIENE</topic><topic>MEDICAL OR VETERINARY SCIENCE</topic><topic>PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES</topic><topic>SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS</topic><toplevel>online_resources</toplevel><creatorcontrib>PARRY, MARK</creatorcontrib><creatorcontrib>WARD, DAVID</creatorcontrib><creatorcontrib>RICHTER, ANNETT</creatorcontrib><creatorcontrib>MUNDRY, TOBIAS</creatorcontrib><creatorcontrib>BOTHE, CLEMENS</creatorcontrib><creatorcontrib>OLENIK, BRITTA</creatorcontrib><creatorcontrib>FABER, HELENE</creatorcontrib><creatorcontrib>NAGELSCHMITZ, JOHANNES</creatorcontrib><creatorcontrib>BECKER, GUIDO</creatorcontrib><creatorcontrib>BECKER-PELSTER, EVA MARIA</creatorcontrib><creatorcontrib>RSLER, BERND</creatorcontrib><creatorcontrib>EGGER, JULIAN</creatorcontrib><creatorcontrib>HAHN, MICHAEL</creatorcontrib><creatorcontrib>FEY, PETER</creatorcontrib><creatorcontrib>SCHIRMER, HEIKO</creatorcontrib><creatorcontrib>KEIL, BIRGIT</creatorcontrib><creatorcontrib>TEREBESI, ILDIKO</creatorcontrib><creatorcontrib>LANG, DIETER</creatorcontrib><creatorcontrib>JUNG, DAVID</creatorcontrib><creatorcontrib>VITRE, CECILE</creatorcontrib><creatorcontrib>TINEL, HANNA</creatorcontrib><creatorcontrib>WEIMANN, GERRIT</creatorcontrib><creatorcontrib>SALEH, SOUNDOS</creatorcontrib><creatorcontrib>DIETZ, LISA</creatorcontrib><collection>esp@cenet</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>PARRY, MARK</au><au>WARD, DAVID</au><au>RICHTER, ANNETT</au><au>MUNDRY, TOBIAS</au><au>BOTHE, CLEMENS</au><au>OLENIK, BRITTA</au><au>FABER, HELENE</au><au>NAGELSCHMITZ, JOHANNES</au><au>BECKER, GUIDO</au><au>BECKER-PELSTER, EVA MARIA</au><au>RSLER, BERND</au><au>EGGER, JULIAN</au><au>HAHN, MICHAEL</au><au>FEY, PETER</au><au>SCHIRMER, HEIKO</au><au>KEIL, BIRGIT</au><au>TEREBESI, ILDIKO</au><au>LANG, DIETER</au><au>JUNG, DAVID</au><au>VITRE, CECILE</au><au>TINEL, HANNA</au><au>WEIMANN, GERRIT</au><au>SALEH, SOUNDOS</au><au>DIETZ, LISA</au><format>patent</format><genre>patent</genre><ristype>GEN</ristype><title>FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN</title><date>2024-03-27</date><risdate>2024</risdate><abstract>La presente invención se refiere a formulaciones farmacéuticas de polvo seco, que comprenden ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico de fórmula (1), preferiblemente en forma de una de sus sales o solvatos o hidratos, preferiblemente ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato I de fórmula (1-M-I) o ácido (5S)-{[2-(4-carboxifenil)etil][2-(2-{[3-cloro-4-(trifluorometil)bifenil-4-il]metoxi}fenil)etil]-amino}-5,6,7,8-tetrahidroquinolin-2-carboxílico monohidrato II de fórmula (1-M-II) en combinación con un portador de lactosa, que comprende lactosa monohidrato como mezcla de lactosa gruesa y lactosa fina, y al proceso de manufactura de dichas formulaciones farmacéuticas de polvo seco y su aplicación para usar en el tratamiento de trastornos cardiopulmonares, tales como hipertensión arterial pulmonar (PAH), hipertensión pulmonar tromboembólica crónica (CTEPH) e hipertensión pulmonar (PH) asociada con enfermedad pulmonar crónica (PH grupo 3) tal como hipertensión pulmonar en la enfermedad pulmonar obstructiva crónica (PH-EPOC) e hipertensión pulmonar con neumonía intersticial idiopática (PH-IIP).
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).</abstract><oa>free_for_read</oa></addata></record> |
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| title | FORMULACIÓN FARMACÉUTICA DE POLVO SECO PARA INHALACIÓN Y PROCESO DE PREPARACIÓN |
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