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1. 发明授权

US11590205B2 Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents 有权
公开(公告)号：US11590205B2
公开(公告)日：2023-02-28
申请号：US15763050
申请日：2016-09-25
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven Prestrelski , Martin Donovan , Michael Sandoval
IPC分类号： A61K38/26 , A61K47/02 , A61K47/20 , A61K9/00 , A61K47/26 , A61K47/10
摘要： Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

2. 发明授权

US11576951B2 Stable therapeutic compositions in aprotic polar solvents and methods of manufacturing the same 有权
公开(公告)号：US11576951B2
公开(公告)日：2023-02-14
申请号：US16888028
申请日：2020-05-29
申请人： XERIS PHARMACEUTICALS, INC.
发明人： Martin Donovan , Wendy Hu
IPC分类号： A61K38/26 , A61K47/02 , A61K47/10 , A61K47/26 , A61P3/10 , A61K45/06 , A61K9/08 , A61K47/20 , A61K9/00
摘要： The present invention concerns the use of aprotic polar solvents, water, and an ionization stabilizing agent to prepare device compatible stable therapeutic formulations by dissolving a therapeutic agent (active ingredient) in an aprotic polar solvent system that can then be used with various devices (e.g., pumps, infusion sets) for administration of the formulation. In certain embodiments, the invention is directed to formulations comprising one or more therapeutic agents, as well as methods of making such formulations, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system, such as a DMSO/water admixture, comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

3. 发明授权

US11446310B2 Stable formulations for parenteral injection of small molecule drugs 有权
公开(公告)号：US11446310B2
公开(公告)日：2022-09-20
申请号：US16945598
申请日：2020-07-31
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven J. Prestrelski , Nancy Scott
IPC分类号： A61K31/5513 , A61K9/00 , A61K47/22 , A61K47/20 , A61K47/14 , A61K47/10 , A61K31/137 , A61K31/167 , A61K31/352 , A61K31/4045 , A61K31/4196 , A61K31/496 , A61K31/55 , A61K31/675 , A61K31/7036 , A61K9/08 , A61P25/00
摘要： Disclosed is a stable liquid formulation for parenteral injection comprising a biocompatible non-aqueous solvent and a small molecule drug, or a salt thereof, solubilized within the non-aqueous solvent, wherein the liquid formulation comprises less than 10% by weight residual water, and wherein the volume of the liquid formulation to be parenterally injected is from 0.1 μl to 3 ml.

4. 发明申请

US20210030847A1 TREATMENT OF POST-BARIATRIC HYPOGLYCEMIA USING MINI-DOSE STABLE GLUCAGON 有权
公开(公告)号：US20210030847A1
公开(公告)日：2021-02-04
申请号：US16964124
申请日：2019-01-23
申请人： XERIS PHARMACEUTICALS, INC. , Joslin Diabetes Center, Inc.
发明人： Brett NEWSWANGER , Steven J. PRESTRELSKI , Mary-Elizabeth PATTI
IPC分类号： A61K38/26 , A61P3/08
摘要： Post-bariatric hypoglycemia (PBH) is an increasingly-recognized complication of gastric bypass surgery. Current therapeutic options have suboptimal efficacy. Small doses of stable liquid glucagon can be used to treat or prevent post-bariatric hypoglycemia.

5. 发明申请

US20180271948A1 Methods for Producing Stable Therapeutic Glucagon Formulations in Aprotic Polar Solvents 审中-公开
公开(公告)号：US20180271948A1
公开(公告)日：2018-09-27
申请号：US15763050
申请日：2016-09-25
申请人： Xeris Pharmaceuticals, inc.
发明人： Steven PRESTRELSKI , Martin DONOVAN , Michael SANDOVAL
IPC分类号： A61K38/26 , A61K47/02 , A61K47/20 , A61K47/10 , A61K47/26 , A61K9/00
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/0029 , A61K47/02 , A61K47/10 , A61K47/20 , A61K47/26
摘要： Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

6. 发明授权

US09125805B2 Stable formulations for parenteral injection of small molecule drugs 有权
标题翻译：用于肠胃外注射小分子药物的稳定制剂
公开(公告)号：US09125805B2
公开(公告)日：2015-09-08
申请号：US13829937
申请日：2013-03-14
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven J. Prestrelski , Nancy Scott
IPC分类号： A61K9/00 , A61K31/5513 , A61K47/14 , A61K47/10 , A61K47/22 , A61K47/20 , A61K9/08 , A61K31/137 , A61K31/167 , A61K31/352 , A61K31/4045 , A61K31/4196 , A61K31/496 , A61K31/55 , A61K31/675 , A61K31/7036
CPC分类号： A61K31/5513 , A61K9/0019 , A61K9/08 , A61K31/137 , A61K31/167 , A61K31/352 , A61K31/4045 , A61K31/4196 , A61K31/496 , A61K31/55 , A61K31/675 , A61K31/7036 , A61K47/10 , A61K47/14 , A61K47/20 , A61K47/22
摘要： Disclosed is a stable liquid formulation for parenteral injection comprising a biocompatible non-aqueous solvent and a small molecule drug, or a salt thereof, solubilized within the non-aqueous solvent, wherein the liquid formulation comprises less than 10% by weight residual water, and wherein the volume of the liquid formulation to be parenterally injected is from 0.1 μl to 3 ml.
摘要翻译：公开了用于肠胃外注射的稳定的液体制剂，其包含溶解在非水溶剂中的生物相容性非水溶剂和小分子药物或其盐，其中所述液体制剂包含小于10重量％的残留水，以及其中待肠胃外注射的液体制剂的体积为0.1μl至3ml。

7. 发明申请

US20140363492A1 INTRACUTANEOUS INJECTION 审中-公开
标题翻译：异位注射
公开(公告)号：US20140363492A1
公开(公告)日：2014-12-11
申请号：US14289448
申请日：2014-05-28
申请人： XERIS PHARMACEUTICALS, INC.
发明人： Steven PRESTRELSKI , Kevin BRODBECK
IPC分类号： A61K9/00 , A61K38/26 , A61K47/14 , A61K9/19 , A61K9/16 , A61K47/22 , A61K38/27 , A61K9/127
CPC分类号： A61K9/0021 , A61K9/0014 , A61K9/127 , A61K9/16 , A61K9/1647 , A61K9/19 , A61K38/26 , A61K38/27 , A61K47/14 , A61K47/22 , A61M5/1782 , A61M5/19 , A61M5/2033 , A61M5/2053 , A61M5/31513 , A61M5/31531 , A61M5/31548 , A61M5/31563 , A61M5/3234 , A61M5/326 , A61M5/3286 , A61M5/329 , A61M5/42 , A61M5/46 , A61M5/5086 , A61M37/00 , A61M37/0069 , A61M2005/2013 , A61M2005/206 , A61M2005/2073 , A61M2205/59
摘要： The delivery of biopharmaceutical and other therapeutic agents parenterally to an animal via a minimally invasive, low pain administration is provided. The agents are delivered to the patient via, e.g., the epidermal, dermal, or subcutaneous layer of the skin in a concentrated fours of injectable paste of slurry.
摘要翻译：提供生物药物和其它治疗剂通过微创低剂量给药向肠胃外输送给动物。药剂通过例如皮肤的表皮，皮肤或皮下层以浓缩的四种可注射的浆料浆剂递送至患者。

8. 发明申请

US20140221288A1 METHODS FOR RAPIDLY TREATING SEVERE HYPOGLYCEMIA 有权
标题翻译：快速治疗严重高血压的方法
公开(公告)号：US20140221288A1
公开(公告)日：2014-08-07
申请号：US13826662
申请日：2013-03-14
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven J. Prestrelski , Brett Newswanger
IPC分类号： A61K38/26
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/19
摘要： Disclosed is a method for treating or preventing hypoglycemia in a patient comprising administering an effective amount of a composition comprising a glucagon peptide which has been dried in a non-volatile buffer, and wherein the glucagon peptide has a pH memory that is about equal to the pH of the glucagon peptide in the non-volatile buffer, and an aprotic polar solvent, wherein the moisture content of the formulation is less than 5%, and wherein the dried glucagon peptide maintains the pH memory that is about equal to the pH of the glucagon peptide in the non-volatile buffer when the dried glucagon peptide is reconstituted in the aprotic polar solvent, wherein the patient has been diagnosed as having a blood glucose level between 0 mg/dL and less than 50 mg/dL or has an indication of impending hypoglycemia based on a blood glucose monitoring device before administration of the composition, and wherein the patient has a blood glucose level greater than 50 mg/dL to 180 mg/dL within 1 to 20 minutes after administration of the composition.
摘要翻译：公开了一种用于治疗或预防患者中的低血糖的方法，包括给予有效量的包含已在非挥发性缓冲液中干燥的胰高血糖素肽的组合物，并且其中所述胰高血糖素肽具有约等于胰高血糖素肽在非挥发性缓冲液中的pH以及非质子极性溶剂，其中制剂的水分含量小于5％，并且其中干燥的胰高血糖素肽保持pH记忆大约等于当干性胰高血糖素肽在非质子极性溶剂中重构时，在非挥发性缓冲液中的胰高血糖素肽，其中所述患者被诊断为具有0mg / dL至小于50mg / dL的血糖水平或具有在施用组合物之前基于血糖监测装置的即将发生的低血糖，并且其中所述患者的血糖水平在1t以内大于50mg / dL至180mg / dL ○给予组合物20分钟。

9. 发明申请

US20140179600A1 STABLE FORMULATIONS FOR PARENTERAL INJECTION OF PEPTIDE DRUGS 有权
标题翻译：用于子宫内膜注射剂的稳定制剂
公开(公告)号：US20140179600A1
公开(公告)日：2014-06-26
申请号：US14192697
申请日：2014-02-27
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven Prestrelski , John Kinzell
IPC分类号： A61K47/22 , A61K47/20 , A61K38/26
CPC分类号： A61K38/28 , A61K9/0019 , A61K9/19 , A61K38/02 , A61K38/09 , A61K38/16 , A61K38/17 , A61K38/1709 , A61K38/1816 , A61K38/22 , A61K38/2207 , A61K38/25 , A61K38/26 , A61K38/29 , A61K38/30 , A61K38/4893 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/183 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/36
摘要： Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.
摘要翻译：提供了用于胃肠外注射肽药物的稳定制剂和使用这种稳定制剂的方法。特别地，本发明提供用于肠胃外注射胰高血糖素的稳定制剂以及使用这种胰高血糖素制剂治疗低血糖症的方法，特别是在紧急情况下严重低血糖症。

10. 发明申请

US20140171362A1 STABLE FORMULATIONS FOR PARENTERAL INJECTION OF PEPTIDE DRUGS 有权
公开(公告)号：US20140171362A1
公开(公告)日：2014-06-19
申请号：US14188464
申请日：2014-02-24
申请人： Xeris Pharmaceuticals, Inc.
发明人： Steven Prestrelski , John Kinzell
IPC分类号： A61K38/29 , A61K38/22 , A61K38/26 , A61K38/28
CPC分类号： A61K38/28 , A61K9/0019 , A61K9/19 , A61K38/02 , A61K38/09 , A61K38/16 , A61K38/17 , A61K38/1709 , A61K38/1816 , A61K38/22 , A61K38/2207 , A61K38/25 , A61K38/26 , A61K38/29 , A61K38/30 , A61K38/4893 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/183 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/36
摘要： Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.

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