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公开(公告)号：US20200215162A1
公开(公告)日：2020-07-09
申请号：US16600722
申请日：2019-10-14
IPC分类号： A61K38/26 , A61M5/142 , A61K47/12 , A61K9/08 , A61K47/18 , A61M5/32 , A61K9/00 , A61K47/02 , A61K47/10 , A61K47/20 , A61K47/26 , A61K38/00 , A61K47/00
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.
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公开(公告)号：US20170312341A1
公开(公告)日：2017-11-02
申请号：US15594998
申请日：2017-05-15
IPC分类号： A61K38/26 , A61K47/26 , A61K47/20 , A61K47/12 , A61K47/10 , A61K47/02 , A61K47/00 , A61K38/00 , A61K9/08 , A61M5/142 , A61K9/00
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/08 , A61K38/00 , A61K47/00 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/186 , A61K47/20 , A61K47/26 , A61M5/142 , A61M5/32
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.
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公开(公告)号：US20140349926A1
公开(公告)日：2014-11-27
申请号：US14354848
申请日：2012-10-31
发明人： Steven Prestrelski , Nancy Scott
摘要： Disclosed is a formulation for parenteral administration comprising insulin that comprises a pH memory between 1 to 4 or between 6 to 8 and an aprotic polar solvent, wherein the insulin is solubilized in the aprotic polar solvent, wherein the solubilized insulin comprises stable monomeric or dimeric forms of insulin or mixtures thereof, and wherein the water content of the formulation is equal to or less than 15% w/v.
摘要翻译： 公开了一种用于肠胃外给药的制剂，其包含含有1至4或6至8之间的pH记忆和非质子极性溶剂的胰岛素，其中所述胰岛素溶解在非质子极性溶剂中，其中所述溶解的胰岛素包含稳定的单体或二聚体形式 的胰岛素或其混合物，并且其中制剂的水含量等于或小于15％w / v。
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公开(公告)号：US11590205B2
公开(公告)日：2023-02-28
申请号：US15763050
申请日：2016-09-25
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.
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公开(公告)号：US20140179600A1
公开(公告)日：2014-06-26
申请号：US14192697
申请日：2014-02-27
发明人： Steven Prestrelski , John Kinzell
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。
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公开(公告)号：US20140171362A1
公开(公告)日：2014-06-19
申请号：US14188464
申请日：2014-02-24
发明人： Steven Prestrelski , John Kinzell
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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公开(公告)号：US11964003B2
公开(公告)日：2024-04-23
申请号：US17359202
申请日：2021-06-25
摘要： The present invention relates to the use of aprotic polar solvents and an ionization stabilizing agent to prepare storage stable sustained release therapeutic formulations by dissolving a therapeutic agent (active ingredient) in an aprotic polar solvent system that can then be administered to patients suffering from or predisposed to a variety of physical conditions or disorders, notably hypoglycemia. 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 such as DMSO, comprising at least one ionization stabilizing excipient (suitably, a mineral acid) and at least one sustained release modifier (suitably, a divalent cation-donating compound such as a zinc salt and/or a polymer such as a PLGA) in concentrations sufficient to impart physical and chemical stability to the therapeutic agent and to produce a formulation that results in a sustained release of the therapeutic agent into the bloodstream of an animal to which the formulation has been administered. The invention also relates to methods of producing such storage stable sustained release therapeutic formulations and to methods of treating, preventing and diagnosing certain physical conditions and disorders, notably hypoglycemia, by administering such storage stable sustained release therapeutic formulations to a patient.
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公开(公告)号：US10987399B2
公开(公告)日：2021-04-27
申请号：US15077633
申请日：2016-03-22
发明人： Steven Prestrelski , John Kinzell
IPC分类号： A61K38/02 , A61K38/16 , A61P3/10 , A61P3/08 , A61K47/26 , A61K47/36 , A61K9/00 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/20 , A61K38/17 , A61K38/22 , A61K38/26 , A61K47/02 , A61K47/18 , A61K38/09 , A61K38/18 , A61K38/25 , A61K38/30 , A61K38/48 , A61K9/08 , A61K38/28 , A61K47/22 , A61K38/29
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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公开(公告)号：US09138479B2
公开(公告)日：2015-09-22
申请号：US14354848
申请日：2012-10-31
发明人： Steven Prestrelski
摘要： Disclosed is a formulation for parenteral administration comprising insulin that comprises a pH memory between 1 to 4 or between 6 to 8 and an aprotic polar solvent, wherein the insulin is solubilized in the aprotic polar solvent, wherein the solubilized insulin comprises stable monomeric or dimeric forms of insulin or mixtures thereof, and wherein the water content of the formulation is equal to or less than 15% w/v.
摘要翻译： 公开了一种用于肠胃外给药的制剂，其包含含有1至4或6至8之间的pH记忆和非质子极性溶剂的胰岛素，其中所述胰岛素溶解在非质子极性溶剂中，其中所述溶解的胰岛素包含稳定的单体或二聚体形式 的胰岛素或其混合物，并且其中制剂的水含量等于或小于15％w / v。
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公开(公告)号：US20170087215A1
公开(公告)日：2017-03-30
申请号：US15136650
申请日：2016-04-22
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/08 , A61K38/00 , A61K47/00 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/186 , A61K47/20 , A61K47/26 , A61M5/142
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.
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