公开(公告)号：US11344517B2

公开(公告)日：2022-05-31

申请号：US14411532

申请日：2013-06-27

申请人： Sintetica S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/167 ,  A61K31/245 ,  A61K9/00 ,  A61K31/445 ,  A61K31/381 ,  A61K31/47 ,  A61K9/08

摘要： The present invention relates to an acetaminophen injectable aqueous solution for use in the treatment or in the prevention of pain by spinal administration, wherein said acetaminophen injectable solution is supersaturated. In certain embodiments, the acetaminophen injectable aqueous solution is administered simultaneously, separately or sequentially with a local anaesthetic by spinal administration.

公开(公告)号：US20220117843A1

公开(公告)日：2022-04-21

申请号：US17489363

申请日：2021-09-29

申请人： Sintetica S.A.

发明人： Nicola Caronzolo ,  Elizabetta Donati ,  Clara Bianchi

IPC分类号： A61J1/14 ,  A61K31/137 ,  A61J1/10 ,  A61K47/02

摘要： Provided are ready to use drip bags of dilute noradrenaline having improved stability in terms of subvisible particle formation.

公开(公告)号：USRE49422E1

公开(公告)日：2023-02-21

申请号：US17006840

申请日：2020-08-30

申请人： Sintetica S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/137 ,  A61K9/00 ,  A61K9/08 ,  A61K47/02 ,  A61L2/00

摘要： In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.

公开(公告)号：US10251848B2

公开(公告)日：2019-04-09

申请号：US15118864

申请日：2015-02-26

申请人： SINTETICA S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/137 ,  A61K9/00 ,  A61K47/02 ,  A61K9/08 ,  A61L2/00

摘要： In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.

公开(公告)号：US09504666B2

公开(公告)日：2016-11-29

申请号：US14650583

申请日：2013-12-11

申请人： SINTETICA S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/245 ,  A61K31/573 ,  A61K31/167 ,  A61K9/00

CPC分类号： A61K31/245 ,  A61K9/0085 ,  A61K31/167 ,  A61K31/573

摘要： This invention relates to an injectable pharmaceutical composition based on chloroprocaine or salts and/or derivatives thereof for use in central loco-regional anesthesia by intrathecal administration in repeated doses. Unexpectedly, the intrathecal administration in repeated doses of chloroprocaine does not increase the neurotoxicity of this drug in statistically significant manner.

摘要翻译： 本发明涉及基于氯普鲁卡因或其盐和/或其衍生物的可注射药物组合物，其用于通过鞘内施用重复剂量的中心局部麻醉。 意外的是，重复剂量的氯普鲁卡因的鞘内给药不会以统计学显着的方式增加该药物的神经毒性。

公开(公告)号：US20220257537A1

公开(公告)日：2022-08-18

申请号：US17670620

申请日：2022-02-14

申请人： Sintetica S.A.

发明人： Nicola Caronzolo ,  Elisabetta Donati ,  Clara Bianchi

IPC分类号： A61K31/137 ,  A61M5/14 ,  A61K47/54

摘要： Ready to use large volume containers of dilute solutions of phenylephrine having excellent shelf stability.

公开(公告)号：US20150148379A1

公开(公告)日：2015-05-28

申请号：US14411532

申请日：2013-06-27

申请人： Sintetica S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/167 ,  A61K31/445 ,  A61K9/00 ,  A61K31/245

CPC分类号： A61K31/167 ,  A61K9/0085 ,  A61K9/08 ,  A61K31/245 ,  A61K31/381 ,  A61K31/445 ,  A61K31/47 ,  A61K2300/00

摘要： The present invention relates to an acetaminophen injectable aqueous solution for use in the treatment or in the prevention of pain by spinal administration, wherein said acetaminophen injectable solution is supersaturated. In certain embodiments, the acetaminophen injectable aqueous solution is administered simultaneously, separately or sequentially with a local anaesthetic by spinal administration.

摘要翻译： 本发明涉及用于治疗或通过脊柱给药预防疼痛的对乙酰氨基酚注射用水溶液，其中所述对乙酰氨基酚注射液过饱和。 在某些实施方案中，对乙酰氨基酚可注射水溶液通过脊髓给药与局部麻醉剂同时，分开或依次给药。

公开(公告)号：USRE49443E1

公开(公告)日：2023-03-07

申请号：US17006838

申请日：2020-08-30

申请人： Sintetica S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/137 ,  A61K9/00 ,  A61K9/08 ,  A61K47/02 ,  A61L2/00

摘要： In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.

公开(公告)号：US20170049720A1

公开(公告)日：2017-02-23

申请号：US15118864

申请日：2015-02-26

申请人： SINTETICA S.A.

发明人： Augusto Mitidieri ,  Elisabetta Donati ,  Nicola Caronzolo

IPC分类号： A61K31/137 ,  A61L2/00 ,  A61K47/02 ,  A61K9/00 ,  A61K9/08

CPC分类号： A61K31/137 ,  A61K9/0019 ,  A61K9/08 ,  A61K47/02 ,  A61L2/0023

摘要： In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.

摘要翻译： 在第一方面，本发明涉及一种制备具有低含量去甲肾上腺素的稳定的可注射溶液的方法，其包括将去甲肾上腺素和任选的赋形剂溶解在脱氧或脱气的水中，在氮气流中过滤所得的去甲肾上腺素溶液，分布 在氮气流中的溶液，并灭菌，最好是热。 本发明还提供了一种稳定的可注射溶液，其具有低含量的去甲肾上腺素，基本上不含抗氧化和防腐剂，以及其在医药领域中的用途。

公开(公告)号：US20230398070A1

公开(公告)日：2023-12-14

申请号：US18032188

申请日：2021-09-29

申请人： SINTETICA S.A.

发明人： Nicola Caronzolo ,  Elisabetta Donati ,  Clara Bianchi

IPC分类号： A61K9/08 ,  A61K31/137 ,  A61K9/00 ,  A61K47/02

CPC分类号： A61K9/08 ,  A61K31/137 ,  A61K9/0019 ,  A61K47/02

摘要： The invention concerns a process for producing a stable, injectable solution containing noradrenaline, comprising the following steps: (a) dissolving noradrenaline and optionally one or more excipients in deoxygenated or degassed water, in order to produce a solution containing noradrenaline; (b) distributing the noradrenaline solution in an inert gas current into a container; (c) sterilizing the solution containing, before step (b) and/or after step (d); (d) hermetically sealing the container; (e) wherein the oxygen concentration in the solution containing noradrenaline is less than 300 ppbw immediately after sealing the container; and (f) wherein the oxygen concentration in the headspace immediately after sealing the container is at most 1.0 percent v/v. It also concerns a drug product obtainable in particular by the above process, and the use of a gas atmosphere comprising an oxygen concentration of less than 1.0 percent v/v, as a headspace in a container comprising a solution containing noradrenaline. Finally, it concerns a process for reducing the number of subvisible particles in a solution containing noradrenaline.