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公开(公告)号：US20240148678A1
公开(公告)日：2024-05-09
申请号：US18490224
申请日：2023-10-19
IPC分类号： A61K31/195 , A61K9/00 , A61K31/145 , A61K31/5513 , A61K47/20 , A61K47/26 , A61K47/34
CPC分类号： A61K31/195 , A61K9/0019 , A61K31/145 , A61K31/5513 , A61K47/20 , A61K47/26 , A61K47/34
摘要： The present invention concerns the use of aprotic polar solvents, water, and an ionization stabilizing agent to prepare stable therapeutic formulations, particularly sustained release formulations, of a variety of active pharmaceutical ingredients (APIs), such as, e.g., levothyroxine. In particular, the invention concerns the use of aprotic polar solvents and at least one ionization stabilizing agent to prepare stable therapeutic formulations of a variety of APIs by dissolving at least one API in an aprotic polar solvent system to produce a stable sustained release therapeutic formulation useful in treating, preventing and/or diagnosing diseases or physical disorders in humans and veterinary animals. The invention also provides methods of manufacturing such formulations.
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2.发明申请公开(公告)号：US20170216529A1
公开(公告)日：2017-08-03
申请号：US15501333
申请日：2015-08-06
发明人： Martin DONOVAN
CPC分类号： A61M5/281 , A61K9/0024 , A61K47/14 , A61K47/26 , A61M5/178 , A61M5/28 , A61M5/315 , A61M5/329 , A61M5/344 , A61M2202/06
摘要： This disclosure includes syringes, kits containing the same, and related methods. Some syringes are pre-loaded with paste and have a syringe body defining a reservoir having an internal first transverse dimension, a paste disposed within the reservoir, the paste having a solids concentration of greater than 50 mg/mL, a needle defining a lumen having an internal second transverse dimension that is smaller than the first transverse dimension, the needle configured to be in fluid communication with the reservoir to allow intracutaneous delivery of the paste, and a plunger and/or piston disposed within the reservoir and configured to be moved to dispense paste from the reservoir through the lumen. Some syringes include a fitting (e.g. Luer fitting) disposed on the syringe body and in fluid communication with the reservoir and a sealing cap disposed on the Luer fitting to seal the reservoir.
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公开(公告)号：US20170007675A1
公开(公告)日：2017-01-12
申请号：US15117016
申请日：2015-02-06
发明人： Steven PRESTRELSKI , Martin DONOVAN
CPC分类号： A61K38/26 , A61K9/0019 , A61K9/19 , A61K38/09 , A61K38/22 , A61K38/25 , A61K38/28 , A61K38/30 , A61K38/4893 , A61K47/02 , A61K47/20 , A61K47/26
摘要： Disclosed is a stable formulation for parenteral injection, as well as methods for its use and preparation, that includes a peptide or a salt thereof that has been previously dried from an aqueous composition comprising a partially volatile buffer, a volatile buffer, a strong acid, or a strong base, or any combination thereof, wherein the dried peptide or salt thereof has a first ionization profile that corresponds to the peptide's optimal stability and solubility, and an aprotic polar solvent, wherein the dried peptide or salt thereof is reconstituted into an aprotic polar solvent and has a second ionization profile in the aprotic polar solvent, wherein the first and second ionization profiles are substantially the same, such as within 1 pH unit of one another.
摘要翻译： 公开了一种用于肠胃外注射的稳定制剂，以及其使用和制备方法，其包括其预先由含有部分挥发性缓冲剂，挥发性缓冲剂，强酸， 或强碱，或其任何组合，其中干燥的肽或其盐具有对应于肽的最佳稳定性和溶解度的第一离子化曲线，以及非质子极性溶剂，其中将干燥的肽或其盐重构成非质子 极性溶剂，并且在非质子极性溶剂中具有第二离子化曲线，其中第一和第二离子化曲线基本相同，例如彼此的1个pH单位内。
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4.发明公开公开(公告)号：US20240316158A1
公开(公告)日：2024-09-26
申请号：US18627095
申请日：2024-04-04
发明人： Martin DONOVAN , Wendy HU
IPC分类号： A61K38/26 , A61K9/00 , A61K9/08 , A61K45/06 , A61K47/02 , A61K47/10 , A61K47/20 , A61K47/26 , A61P3/10
CPC分类号： A61K38/26 , A61K9/08 , A61K45/06 , A61K47/02 , A61K47/10 , A61K47/20 , A61K47/26 , A61P3/10 , A61K9/0019
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.
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5.发明申请公开(公告)号：US20180271948A1
公开(公告)日：2018-09-27
申请号：US15763050
申请日：2016-09-25
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.
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公开(公告)号：US20240207365A1
公开(公告)日：2024-06-27
申请号：US18598577
申请日：2024-03-07
IPC分类号： A61K38/26 , A61K9/00 , A61K9/08 , A61K38/00 , A61K47/00 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/20 , A61K47/26 , A61M5/142 , A61M5/32
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：US20240041984A1
公开(公告)日：2024-02-08
申请号：US18180002
申请日：2023-03-07
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
CPC分类号： A61K38/26 , A61M5/142 , A61K47/12 , A61K9/08 , A61K47/186 , A61K47/183 , A61M5/32 , A61K9/0019 , 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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8.发明公开公开(公告)号：US20230346891A1
公开(公告)日：2023-11-02
申请号：US18168438
申请日：2023-02-13
发明人： Martin DONOVAN , Wendy HU
CPC分类号： A61K38/26 , A61K9/08 , A61K45/06 , A61K47/02 , A61K47/10 , A61K47/20 , A61K47/26 , A61P3/10 , A61K9/0019
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.
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9.发明申请公开(公告)号：US20200376083A1
公开(公告)日：2020-12-03
申请号：US16888028
申请日：2020-05-29
发明人： Martin DONOVAN , Wendy HU
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.
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公开(公告)号：US20240342249A1
公开(公告)日：2024-10-17
申请号：US18640676
申请日：2024-04-19
IPC分类号： A61K38/26 , A61K9/00 , A61K9/08 , A61K38/00 , A61K47/00 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/20 , A61K47/26 , A61M5/142 , A61M5/32
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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