A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.

The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.

开始日期2013-11-01

申办/合作机构

Currax Pharmaceuticals LLC初创企业

100 项与安替比林相关的临床结果

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100 项与安替比林相关的转化医学

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100 项与安替比林相关的专利（医药）

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2,765

项与安替比林相关的文献（医药）

2024-05-01·Journal of pharmaceutical sciences

Design of Ionic Liquid Formulations with Azone-Mimic Structures for Enhanced Drug Skin Permeation

Article

作者: Yamamoto, Aki ; Oshizaka, Takeshi ; Takeuchi, Issei ; Mori, Kenji ; Tanaka, Hikaru ; Sugibayashi, Kenji

Although laurocapram (Azone) significantly enhances the skin permeation of drugs, its development was hindered by its skin irritation. We then developed an Azone-mimic ionic liquid (IL-Azone), composed of less irritating cationic ε-caprolactam and anionic myristic acid. IL-Azone dissociates to the original cation and anion in the presence of water in the formulation. We tried to select a formulation suitable for IL-Azone in the present study. Each formulation contained 5 % of either Azone or IL-Azone along with the model drug antipyrine, and skin permeation experiments of the drug were conducted. The results revealed that IL-Azone did not enhance skin permeation when combined with most formulations tested. However, a notable and rapid enhancement in skin permeation was observed when combined with white petrolatum. This effect could be attributed to the minimal water content in white petrolatum, which prevented IL-Azone degradation. Furthermore, its permeation-enhancing effects from IL-Azone in white petrolatum were more pronounced and rapid than Azone. The rapid onset observed with IL-Azone can be attributed to its degradation into its original components at the interface between the stratum corneum and the living epidermis, which results in a shorter lag time before achieving a steady-state concentration in the SC compared to Azone.

2024-01-01·Current research in toxicology

Placental transfer of tofacitinib in the ex vivo dual-side human placenta perfusion model

Article

作者: van den Broek, Petra H H ; Greupink, Rick ; Eliesen, Gaby A M ; Fransen, Milou ; van Hove, Hedwig

Tofacitinib is a small molecule Janus kinase (JAK) inhibitor, introduced to the European market in 2017, for the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. In the treatment of women with autoimmune diseases, pregnancy is a relevant issue, as such diseases typically affect women in their reproductive years. Currently, there is limited data on the use of tofacitinib during pregnancy. To estimate the extent of placental transfer in the absence of clinical data, we conducted ex vivo dual-side perfused human placental cotyledon perfusions. Term placentas were perfused for 180 min with tofacitinib (100 nM, added to the maternal circuit) in a closed-closed configuration. At the end of the perfusions, drug concentrations in the maternal and fetal reservoirs were near equilibrium, at 35.6 ± 5.5 and 24.8 ± 4.7 nM, respectively. Transfer of tofacitinib was similar to that observed for the passive diffusion marker antipyrine (100 µg/mL, added to the maternal reservoir). Final antipyrine maternal and fetal concentrations amounted to 36.9 ± 3.0 and 36.7 ± 1.3 µg/mL, respectively. In conclusion, in the ex vivo perfused placenta tofacitinib traverses the placental barrier rapidly and extensively. This suggests that substantial fetal tofacitinib exposure will take place after maternal drug dosing.

2024-01-01·Biological & pharmaceutical bulletin

Magnitude of Fruit Juice–Drug Interactions Due to Osmolality-Dependent Fluid Secretion: Differences among Apple, Orange, and Grapefruit Juices

Article

作者: Inoue, Katsuhisa ; Shirasaka, Yoshiyuki ; Tamai, Ikumi ; Takemura, Miyuki

We recently reported that the gastrointestinal (GI) fluid volume is influenced by the solution osmolality, and proposed that this effect may play a role in beverage-drug interactions. Here, we investigated whether osmolality-dependent fluid secretion can explain the difference in the magnitudes of fruit juice-drug interactions depending on the type of fruit juice (grapefruit juice (GFJ), orange juice (OJ), and apple juice (AJ)). The osmolality of GFJ, OJ, and AJ used in this study was found to be 552, 686, and 749 mOsm/kg, respectively. Measurements of intestinal fluid movement following beverage administration by the in situ closed-loop technique revealed the following rank order for fluid volume in rat ileum: AJ > OJ > GFJ > purified water, suggesting that water movement is dependent on the osmolality of these beverages. Such changes in GI fluid volume are expected to alter the luminal drug concentration, potentially contributing to the magnitude of beverage-drug interactions. Indeed, in vivo pharmacokinetic study in rats revealed that the plasma concentration of atenolol, a low-permeability drug, was the highest after oral administration in purified water, followed by GFJ and OJ, and was the lowest after administration in AJ. In contrast, antipyrine, a high-permeability drug, showed no significant difference in plasma concentration after administration in purified water and fruit juices, suggesting that the absorption of high-permeability drugs is less affected by solution osmolality. Our findings indicate that differences in the magnitude of beverage-drug interactions can be at least partly explained by differences in the osmolality of the beverages ingested.

项与安替比林相关的新闻（医药）

2023-03-20

·E药经理人

E周要闻｜多家Biotech终止或暂停HER2 ADC。巨额并购重启，行业春天要来了？

这一周，行业开始呈现“破”与“立”的生机。春天已经悄然到来了！辉瑞以428亿元收购seagen打破了并购交易的“冰河期”。依生生物以SPAC方式成功登陆纳斯达克市场，打破了中概股在美上市的漫长寒冬。另一方面，以康方生物为代表的biopharma交出喜人的成绩单。不过复苏当中，仍会有冬天余存的“寒毒”。火热的ADC在上一周接连遇挫，国内东曜药业决定终止HER2 ADC临床，国外Mersana暂停一项HER2 ADC的临床试验。接下来看看，上一周E药经理人精选的行业重磅新闻有哪些呢？政策动态医保局召集医院，要开国谈药物“药事会”业界流出某省医保局于3月16日开会的消息---召集各地设区市的医保局、部分三级医院，以及相关企业召开三方沟通会，以此来落实和推动国谈药物进院。医院方的参会成员包括分管采购的副院长及药剂科主任各一名。沟通会开一天。会上，将由部分医院介绍国谈药物进院的经验和做法，企业介绍创新药的特点。135家三级医院采购联盟组建，采购神经介入、外周介入耗材3月13日，河南下发《关于成立河南省公立医疗机构医用耗材采购联盟的通知》，该联盟由郑州大学第一附属医院、河南省人民医院牵头成立，按照临床需求为导向的原则，经专家论证，本次医院联盟采购选取神经介入类、外周介入类医用耗材。大型制药礼来、诺和诺德、赛诺菲胰岛素纷纷加入降价大军在美国国会议员的督促之下，礼来、诺和诺德、赛诺菲胰岛素纷纷加入降价大军。3月16日，赛诺菲宣布来得时（甘精胰岛素）在美国降价78%，对于所有患者自费部分将不超过35美元，无论是否有商业保险。同时，赖谷胰岛素也将降价70%。新的价格将于2024年1月1日生效。3月14日，诺和诺德宣布在美国大幅降低胰岛素类药物的价格，其中门冬胰岛素降价75%，人胰岛素和地特胰岛素降价65%，新价格将从2024年1月起执行。3月1日，礼来制药刚刚宣布将其胰岛素类药物降价70%，患者自费部分每个月不超过35美元。具体而言，非品牌赖脯胰岛素100U/ml的价格降到25美元，2023年5月1日起生效。最主要品种Humalog（赖脯胰岛素品牌药）和二代人胰岛素Humulin降价70%，2023年四季度生效。参考文章：诺和诺德、赛诺菲胰岛素也降价，降幅最高达78%！强生决定暂停西达基奥仑赛在英国的报批程序3月13日，有外媒发布新闻稿，强生已经决定暂停推进与南京传奇合作的BCMA CAR-T西达基奥仑赛用于多发性骨髓瘤在英国的报批程序，原因是暂时无法生产出充足供给支持英国患者所需的产品，但目前正在进行的临床试验仍会继续。参考文章：强生/传奇暂停CAR-T英国报批！国内患者难觅，海外却供不应求，谁卡了产能的脖子？生物科技HER2 ADC临床接连受挫！3月17日，东曜药业发布公告，称针对公司自主研发的HER2靶向抗体偶联药物（ADC）TAA013，基于对该药物未来的商业价值和市场销售情况进行之全面、谨慎的分析及评估，并结合公司战略规划，已决定终止TAA013于中国的III期临床试验研究及开发。而在此之前，2021年2月，百奥泰终止开发HER2 ADC药物BAT8001，因为三期临床未达到相比对照组（拉帕替尼联合卡培他滨）的预设优效目标。海外HER2 ADC也在近日遇挫。3 月 13 日，Mersana Therapeutics 宣布 XMT-2056 （靶向 HER2 新表位的免疫合成 ADC） I 期临床试验暂停。Mersana 表示目前已向 FDA 报告 I 期临床出现与 XMT-2056 治疗相关的 5 级（致命）严重不良事件（SAE），并自愿暂停了该项临床试验。SAE 发生在第二例患者中，具体原因仍在调查中。财报季！Biotech接连公布财报康方生物2022年收入8.33亿元3月16日，康方生物发布2022年财报。报告期内，公司营业收入8.33亿元，研发投入13.23亿元，销售费用5.22亿元。基石药业2022年收入4.81亿元3月15日，基石药业发布2022年财报。报告期内，公司营收4.81亿元，2021年同期为2.43亿元；销售费用为3.27亿元，2021年同期为3.63亿元。云顶新耀依拉环素获批上市3月16日，据NMPA官网，云顶新耀依拉环素获批上市，适应症为成人复杂性腹腔内感染。资本市场IPO：又一Biotech敲开纳斯达克大门！继硕迪生物以IPO首日暴涨73.33%在纳斯达克上市后，又一Biotech通过SPAC机制敲开了纳斯达克的上市大门。2023年3月16日，依生生物宣布与纳斯达克上市SPAC公司Summit Healthcare Acquisition Corp. 正式完成合并。依生生物预计将于2023年3月17日晚间正式在美国纳斯达克市场开始交易，股票及认股权证代码分别为“YS”和“YSBPW”。依生生物也成为了首家通过SPAC机制登陆美国纳斯达克市场的中概Biotech公司。海森药业创业板IPO过会，拟募资6亿元。海森药业是一家专业从事化学药品原料药及中间体研发、生产和销售的高新技术企业，是目前国内阿托伐他汀钙、硫糖铝、安乃近、安替比林等产品主要生产商之一。海森药业经过在原料药领域20余年的深耕，在技术研发、生产制造、工艺设计、质量控制、客户开发等方面积累了丰富的经验，树立了良好的业界口碑。并购：辉瑞收购seagen，结束大并购“冰河期”3月13日，生物科技公司Seagen发布公告表示，辉瑞拟以428亿美元将其收购。这将是ADC领域最大的收购案，也是这两年来金额最大的并购案。“此次收购Seagen”给了一个切入ADC领域的切口。虽然此前辉瑞有两款ADC上市，分别为吉妥珠单抗奥唑米星以及与Celltech合作开发的奥加伊妥珠单抗，但是辉瑞管线中其他在研ADC产品大多处于I/II期或临床前阶段。借此，辉瑞或正式进入全球ADC第一梯队。同一天，赛诺菲宣布，将以总金额近29亿美元的价格收购Provention Bio，从而获得用于延缓1型糖尿病发病的药物Teplizumab。参考文章：宇宙大药厂看中ADC龙头，意在何为？登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

并购带量采购抗体药物偶联物

100 项与安替比林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01776	安替比林	S02DA03 N02BB01	DB01435

研发状态

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适应症	国家/地区	公司	日期
中耳炎	-	-	-
疼痛	-	-	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02037893 (CTgov)	临床2期	疼痛 \| 急性中耳炎	112	Placebo Otic solution+Benzocaine otic solution+Antipyrine (Antipyrine and Benzocaine Otic Solution)	鏇積選遞鑰遞糧鹹範鏇(鑰艱齋糧壓構糧獵鏇廠) = 膚憲壓築蓋衊淵醖鏇範壓獵糧醖積遞製觸範鹹 (築繭廠積鬱範壓壓範選, 簾窪鹽獵鏇壓衊鏇壓願 ~ 膚遞膚築壓築艱繭衊範) 更多	-	2018-08-31
				Placebo Otic solution+Antipyrine Otic Solution (Antipyrine Otic Solution)	鏇積選遞鑰遞糧鹹範鏇(鑰艱齋糧壓構糧獵鏇廠) = 艱襯鏇鬱遞簾願襯繭窪壓獵糧醖積遞製觸範鹹 (築繭廠積鬱範壓壓範選, 製獵鑰餘襯顧糧淵淵淵 ~ 衊廠製衊遞淵鏇鏇遞鬱) 更多