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1. 发明申请

WO2023285532A1 PHARMACEUTICAL COMPOSITION FOR THE ORAL ADMINISTRATION OF POORLY SOLUBLE DRUGS COMPRISING AN AMORPHOUS SOLID DISPERSION 审中-公开
公开(公告)号：WO2023285532A1
公开(公告)日：2023-01-19
申请号：PCT/EP2022/069604
申请日：2022-07-13
申请人： DR. FALK PHARMA GMBH
发明人： STIESS, Michael , TEWES, Bernhard , WILHELM, Rudolph , PROELS, Markus
IPC分类号： A61K9/14 , A61K9/50 , A61K9/16 , A61K31/5025 , A61P29/00
摘要： The invention describes the provision of an amorphous solid dispersion of RhuDex® choline salt. The oral, gastro-resistant formulation is provided with a specific release characteristic. Release is realized at pH values from 6 to 7 in the region of the upper intestine. This region is specifically advantageous if pharmaceutical formulations aim to reach the liver as the primary target organ.

2. 发明申请

WO2021214337A1 SYSTEMIC FORMULATION OF A PYRIDINONE DERIVATE FOR COELIAC DISEASE 审中-公开
公开(公告)号：WO2021214337A1
公开(公告)日：2021-10-28
申请号：PCT/EP2021/060763
申请日：2021-04-24
申请人： DR. FALK PHARMA GMBH
发明人： GREINWALD, Roland , MOHR, Wolfgang , TEWES, Bernhard , WILHELM, Rudolf , MOHRBACHER, Ralf
IPC分类号： A61K9/16 , A61K9/20 , A61K9/28 , A61K9/48 , A61P1/00 , A61P37/06 , A61P43/00 , A61K31/4439 , C07D401/12
摘要： The present invention relates to a systemic formulation, in particular an oral formulation, for the prophylaxis and/or treatment of coeliac disease, i.e. for use in the prophylaxis and/or treatment of coeliac disease.

3. 发明申请

WO2023072368A1 ORAL FORMULATION OF A PYRIDINONE DERIVATE AND USE THEREOF IN PROPHYLAXIS AND/OR TREATMENT OF INTESTINAL FIBROSIS 审中-公开
公开(公告)号：WO2023072368A1
公开(公告)日：2023-05-04
申请号：PCT/EP2021/079584
申请日：2021-10-25
申请人： DR. FALK PHARMA GMBH
发明人： WILHELM, Rudolf , TEWES, Bernhard , GREINWALD, Roland
IPC分类号： A61K9/20 , A61K9/28 , A61K9/50 , A61K31/4439 , A61P13/12 , A61P37/06 , A61P1/00
摘要： The present invention relates to an oral formulation adapted for selective delivery of a drug to the small intestine of a mammal comprising or consisting of: a plurality of particles in form of coated granules, coated pellets, coated beads, coated minicapsules, or coated minitablets, each particle containing (S,E)-methyl-7-(1-(2- (2-ethylbutylamino)-2-oxoethyl)-2-oxo-1,2-dihydro-pyridin-3-ylamino)-6-(1-methyl- 1H-imidazole-5-carboxamido)-7-oxohept-2-enoate of formula (I), or an enantiomer, a solvate, a hydrate or a pharmaceutically acceptable salt thereof as the drug, a core material, and an enteric coating polymer, wherein each particle is coated with at least one coating layer containing or consisting of the enteric coating polymer; a preparation method of said oral formulation; and a medical use of said oral formulation in prophylaxis or treatment of intestinal fibrosis, in particular, fibrostenotic Crohn's disease.

4. 发明申请

WO2021214338A1 SYSTEMIC FORMULATION OF A PYRIDINONE DERIVATE FOR TG2-RELATED DISEASES 审中-公开
公开(公告)号：WO2021214338A1
公开(公告)日：2021-10-28
申请号：PCT/EP2021/060764
申请日：2021-04-24
申请人： DR. FALK PHARMA GMBH , ZEDIRA GMBH
发明人： GREINWALD, Roland , HILS, Martin , MOHR, Wolfgang , PASTERNACK, Ralf , TEWES, Bernhard , WILHELM, Rudolf
IPC分类号： A61K9/16 , A61K9/48 , A61P37/06 , A61K31/4439 , C07D401/12 , A61P1/16 , A61P13/10 , A61P13/12 , A61K9/20
摘要： The present invention relates to a formulation in particular an oral formulation for the prophylaxis and treatment of TG2-related disorders like fibrosis in particular diabetic nephropathy and/or diabetic associated non-alcoholic steatohepatitis (NASH) and/or non-alcoholic steatohepatitis, and its use in the prophylaxis and/or treatment of fibrosis in particular nephropathy, NASH, idiopathic pulmonary fibrosis, and cystic fibrosis. Further, the present application relates also to the use of (S,E)-methyl-7-(1-(2-(2- ethylbutylamino)-2-oxoethyl)-2-oxo-1,2-dihydro-pyridin-3-ylamino)-6-(1-methyl-1H- imidazole-5-carboxamido)-7-oxohept-2-enoate as hepatoprotectant, i.e. as hepatoprotective agent. In addition the present invention relates to a pharmaceutical composition comprising (S,E)-methyl-7-(1-(2-(2-ethylbutylamino)-2-oxoethyl)-2-oxo-1,2- dihydro-pyridin-3-ylamino)-6-(1-methyl-1H-imidazole-5-carboxamido)-7-oxohept-2- enoate for use as hepatoprotective agent and for use in the protection of the liver against liver toxicity, the improvement of liver function, and/or in the prophylaxis or treatment of a liver disease or liver disorder.

5. 发明申请

WO2023072878A1 ORAL FORMULATION OF A PYRIDINONE DERIVATE AND USE THEREOF IN PROPHYLAXIS AND/OR TREATMENT OF INTESTINAL FIBROSIS 审中-公开
公开(公告)号：WO2023072878A1
公开(公告)日：2023-05-04
申请号：PCT/EP2022/079666
申请日：2022-10-24
申请人： DR. FALK PHARMA GMBH
发明人： WILHELM, Rudolf , TEWES, Bernhard , GREINWALD, Roland
IPC分类号： A61K9/20 , A61K9/28 , A61K9/50 , A61K31/4439 , A61P13/12 , A61P37/06 , A61P1/00
摘要： The present invention relates to an oral formulation adapted for selective delivery of a drug to the small intestine of a mammal comprising or consisting of: a plurality of particles in form of coated granules, coated pellets, coated beads, coated minicapsules, or coated minitablets, each particle containing (S,E)-methyl-7-(1-(2-(2-ethylbutylamino)-2-oxoethyl)-2-oxo-1,2-dihydro-pyridin-3-ylamino)-6-(1-methyl-1H-imidazole-5-carboxamido)-7-oxohept-2-enoate of formula (I), or an enantiomer, a solvate, a hydrate or a pharmaceutically acceptable salt thereof as the drug, a core material, and an enteric coating polymer, wherein each particle is coated with at least one coating layer containing or consisting of the enteric coating polymer; a preparation method of said oral formulation; and a medical use of said oral formulation in prophylaxis or treatment of intestinal fibrosis, in particular, fibrostenotic Crohn's disease.

6. 发明申请

WO2009156232A1 VERFAHREN ZUR CHARAKTERISIERUNG DER BIOLOGISCHEN AKTIVITÄT VON HELMINTH-EIERN, NÄMLICH VON TRICHURIS EIERN 审中-公开
标题翻译：方法为表征的寄生虫卵的生物活性，FACT卵鞭
公开(公告)号：WO2009156232A1
公开(公告)日：2009-12-30
申请号：PCT/EP2009/056106
申请日：2009-05-20
申请人： DR. FALK PHARMA GMBH , TEWES, Bernhard , WILHELM, Rudolf
发明人： TEWES, Bernhard , WILHELM, Rudolf
IPC分类号： C12Q1/68 , A01K67/033 , C12Q1/66
CPC分类号： C12Q1/6888 , C12Q1/04 , C12Q1/66 , C12Q2600/158 , G01N33/5029 , G01N2333/43526
摘要： Beschrieben wird ein Verfahren zur Bestimmung der biologischen Aktivität von embryonierten Trichuris Eiern, bei der wenigstens eine der nachfolgenden Bestimmungen durchgeführt wird: a) Bestimmung und/oder Bestätigung des Stadiums der Embryonalentwicklung von Helminth-Eiern mit Hilfe der quantitativen PCR-Analyse unter Verwendung geeigneter Marker-Sequenzen zur Ermittlung der Kopienzahl der genomischen DNA, b) Bestimmung der metabolischen Aktivität von embryonierten Helminth-Eiern mit biochemischen und/oder molekularbiologischen Methoden, c) Bestimmung der Induzierbarkeit der Genexpression in embryonierten Helminth-Eiern, d) mikroskopische Bestimmung der Motilität von im Ei befindlichen Helminth-Larven über lange Beobachtungszeiträume nach Vorinkubation bei erhöhten Temperaturen, und/oder e) Bestimmung der Schlüpfrate von Trichuris-Larven im Versuchstier, wobei die aus dem Darminhalt zurückgewonnenen intakten embryonierten Eier im Vergleich zu einem internen Standard quantifiziert werden.
摘要翻译：公开了执行用于确定含胚鸡蛋鞭，有下列规定的至少一种的生物活性的方法，其中：a）确定和/或使用利用合适的标记是定量PCR分析蠕虫卵的胚胎发育的阶段的确认序列，以确定基因组DNA的拷贝数，b）测定含胚蠕虫卵与生物化学和/或分子生物学方法，c）中确定的基因表达在含胚蠕虫卵的诱导能力，d）中，显微测定的运动性的代谢活性蛋位于蠕虫幼虫在升高的温度下预温育之后测定所述测试动物，其中，从所述肠内容物回收的完整胚卵在比较内部标准quantifiz鞭幼虫孵化率的观察长的时间，和/或e） ated是。

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