主要目的：以持证商为Institut Biochimique SA的双氯芬酸依泊胺贴（规格：1.3%，10cm×14cm；商品名为：Flector）为参比制剂，以杭州端本医药科技有限公司研制的双氯芬酸依泊胺贴 [规格：每贴（14cm×10cm）含双氯芬酸依泊胺180mg，1.3%（每100g膏体中含双氯芬酸依泊胺1.3g）] 为受试制剂，评价两种制剂在中国健康受试者中外用条件下的生物等效性。次要目的： 1）评价受试制剂与参比制剂在中国健康受试者中的安全性； 2）评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性； 3）评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。

开始日期2024-05-06

申办/合作机构

杭州端本医药科技有限公司

CTR20232884 / Completed临床3期

双氯芬酸依泊胺贴治疗局部软组织损伤（拉伤、扭伤、挫伤）引起的疼痛的有效性和安全性多中心、随机、双盲、阳性药、安慰剂平行对照临床试验

以氟比洛芬凝胶贴膏和安慰剂为对照，评价双氯芬酸依泊胺贴治疗局部软组织损伤（拉伤、扭伤、挫伤）引起的疼痛的有效性和安全性。

开始日期2023-11-15

申办/合作机构

南京海纳医药科技股份有限公司

[+1]

ISRCTN59179622 / Completed临床1期

Bioavailability, adhesion and tolerability study for the evaluation of Flector Unidie® medicated plaster applied once a day for 5 consecutive days to healthy volunteers

开始日期2023-10-24

申办/合作机构

IBSA Institut Biochimique SA

100 项与双氯芬酸依泊胺相关的临床结果

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100 项与双氯芬酸依泊胺相关的转化医学

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100 项与双氯芬酸依泊胺相关的专利（医药）

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项与双氯芬酸依泊胺相关的文献（医药）

2023-10-01·Pain and therapy

Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study.

Article

作者: Trevisan, Carlo L M ; Carraro, Andrea ; Baldari, Gemma L A

INTRODUCTION:

The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain.

METHODS:

A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner's clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator's satisfaction with the treatment was also assessed. Subjects initially took 1-2 capsules of the study treatment and then one or two soft capsules every 4-6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period.

RESULTS:

A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated.

CONCLUSIONS:

The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects' overall satisfaction with treatment more than 90%.

TRIAL REGISTRATION:

EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.

2022-10-01·Pharmaceutical research

Effect of Salt Form on Gelation and Drug Delivery Properties of Diclofenac-Loaded Poloxamer Gels for Delivery to Impaired Skin

Article

作者: Fiegel, Jennifer ; Brogden, Nicole K ; Russo, Jackson

PURPOSE:

Treating chronic wounds is a significant clinical challenge, and a topical product would be ideal for pain management. Poloxamer 407, a thermosensitive polymer, would allow an analgesic drug to be topically applied to a wound as a liquid that transitions to a gel at physiologic temperature. Using diclofenac as a model analgesic drug, our goal was to determine effects of salt form on poloxamer gelation and drug delivery from poloxamer gels applied to excised skin with impaired barrier function.

METHODS:

Gelation properties of 17% and 20% poloxamer gels loaded with 0.4 to 1.7% diclofenac sodium, potassium, epolamine, or diethylamine were evaluated rheologically. Drug release and delivery were quantified using cellulose membranes, porcine skin, and tape-stripped porcine skin.

RESULTS:

Poloxamer gelation temperature increased with higher diclofenac concentration, regardless of salt form; the magnitude of increase varied in the following order: sodium>potassium>diethylamine>epolamine. Gelation temperature differences resulting from the various counterions generally matched previously observed trends of ion-specific effects on macromolecule solubility (the Hofmeister series). Despite changes in gelation behavior, we observed minimal corresponding effects on drug release or delivery. There were no significant differences in diclofenac released or delivered through intact porcine skin over 48 h. However, in studies with impaired (tape-stripped) skin, diclofenac delivery was slowest overall with the epolamine salt.

CONCLUSION:

Varying the salt form of a model analgesic drug can impact gelation and drug delivery characteristics of poloxamer systems. Further study of the mechanisms of these changes will be important for continued development of topical poloxamer products for clinical wound care.

2022-01-01·Clinical drug investigation4区 · 医学

Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial

4区 · 医学

Article

作者: Ledesma, Gilbert ; Wisman, Paul P ; Jones, Clarence ; Jones, Christopher A ; Frangione, Valeria ; Hoehler, Fred K

BACKGROUND AND OBJECTIVE:

A topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions; however, its safety and efficacy have not been investigated in a pediatric population. This study assessed the safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children.

METHODS:

This was an open-label, single-arm, phase IV study at ten USA-based family medicine or pediatric practices in children aged 6-16 years with a clinically significant minor soft tissue injury sustained within the preceding 96 h and at least moderate spontaneous pain on the Wong-Baker FACES^® Pain Rating Scale. The FLECTOR topical system was applied twice daily until pain resolution or Day 14. The primary endpoint was local tolerability and systemic safety. Key secondary endpoints were diclofenac plasma concentrations and analgesic efficacy.

RESULTS:

104 patients were enrolled; 52 were 6-11 years old, and 52 were 12-16 years old (mean age 11.6 years). The maximum tolerability score experienced by any patient was 1 (faint redness). Fourteen adverse events (none serious) in nine patients (8.7%) were considered possibly treatment-related. Reduction in pain during the study was somewhat greater for patients aged 6-11 versus 12-16 years (p < 0.011). The diclofenac plasma concentration tended to be higher in the younger age group compared with older patients: 1.83 versus 1.46 ng/mL at the first assessment and 2.49 versus 1.11 ng/mL at the last assessment (p = 0.002).

CONCLUSION:

The FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT02132247.

项与双氯芬酸依泊胺相关的新闻（医药）

2024-11-22

·Business Wire

Virpax Announces Positive Results for the Swine Model Dose Range Finding Study for Probudur™

BERWYN, Pa.--( BUSINESS WIRE )-- Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”) , a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today announced results from a minipig Dose Range Finding (“DRF”) study for Probudur. Probudur is the company’s long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief. The DRF study was conducted to evaluate the tolerance of Probudur in an incisional wound healing model in minipigs. Probudur was injected locally into the tissue surrounding the incision area. All of the minipigs demonstrated positive tolerance to Probudur and no adverse effects were noted. The development program for Probudur continues to support the Company’s belief that Probudur has the potential to provide both immediate and sustained pain relief at the incisional area. “These positive study results in our pharmacokinetics and safety studies for Probudur and continue to demonstrate both immediate relief as well as sustained relief at the wound site,” stated Jatinder Dhaliwal, Chief Executive Officer of Virpax. “The completion of these studies brings us another step closer to filing our Investigational New Drug Application (IND) for Probudur.” Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In preclinical studies, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six days. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com .and follow us on Twitter, LinkedIn and YouTube. Forward-Looking Statements This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

临床结果

2024-11-21

·Business Wire

Virpax Announces Agreement with the U.S. Department of Health and Human Services for the Developmental Extension for NES100 Towards IND for Acute and Chronic Non-Cancer Pain Alternative

BERWYN, Pa.--( BUSINESS WIRE )-- Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”) , a company specializing in developing pharmaceutical products for pain management, announced that it has been granted an extension of its cooperative research and development agreement with the National Center for Advancing Translational Sciences (NCATS), an institute/center of the National Institutes of Health (NIH), U.S. Department of Health and Human Services. This collaboration is for the continued development of Virpax’s product candidate, NES100, an intranasal peptide, for the management of acute and chronic non-cancer pain. NES100 is an enkephalin drug product based on a type of nanotechnology delivery approach. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. We believe that the nanotechnology may enable and enhance the delivery of this metabolically labile peptide drug into the brain. NES100 is the first investigational product formulation delivered via the nasal route with the potential to enhance enkephalin transport to the brain. NES100 uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brain by flowing along the olfactory nerve pathway. The Molecular Envelope Technology (MET) is designed to protect and help carry the drug to the brain with the goal of promptly suppressing pain by binding to the delta opioid receptors. NES100 has demonstrated analgesic potential in animal models without the development of opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with use of opioids. Jatinder Dhaliwal, Chief Executive Officer of Virpax, commented, "We are excited that this collaboration has been extended with NCATS and the NIH Helping to End Addiction Long-term (HEAL) initiative as we believe that it may help Virpax develop an effective and safe alternative to conventional opioids used by patients to manage acute and chronic pain. We believe that the NIH/NCATS collaborative agreement will enable our team to maintain momentum in both our pre-clinical and clinical development strategies." About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com .and follow us on Twitter, LinkedIn and YouTube. Forward-Looking Statements This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

2024-08-26

·CPHI制药在线

会议报名 | 东南亚医药市场开拓机遇与挑战主题会议

✦ ✦ ✦ 随着中国经济的快速增长和科技实力的提升，国内新药研发蓬勃发展，为出海打下良好基础。一直以来，中国医药、原料药出口贸易在东南亚市场占有举足轻重的份额。其中，印度尼西亚、泰国、越南、菲律宾和马来西亚五个国家占据了东南亚医药市场的90%以上。未来这些国家将会成为国内企业转战的重要市场，包括投资建厂等深度合作开发。为助力中国药企加速布局东南亚医药市场，9月11日，东南亚医药市场开拓机遇与挑战主题会议将于CPHI & PMEC 制药工业展（深圳）展会期间在深圳会展中心（福田）举办。会议将从当下市场的最新国际形势出发，结合案例与报告，与上下游企业共同探讨东南亚市场的发展机遇。 ✦ ✦ ✦ 东南亚医药市场开拓机遇与挑战主题会议会议时间 9月11日会议地点深圳会展中心（福田）论坛区A（展位：9A56）主办单位上海博华国际展览有限公司承办单位北京东方比特科技有限公司协办单位 E药经理人扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份 SHENZHEN 会议议程 09:30 主持人致辞 09:40-10:20 东南亚国家医药国际贸易报告嘉宾介绍吴惠芳北京东方比特（健康网）总经理兼首席研究员，北京玉德未来控股有限公司副总裁吴女士在军事医学科学院药物分析专业获理学硕士学位，1980年起从事药学相关工作，2000年前在部队医疗、科研机构从事临床药学、科研管理等工作，技术职务副主任药师。2000年退役后从事医药信息研究工作，专注于医药行业研究、市场研究、产业链结构研究等领域。在医药原料药、医药商品进出口、医药产业数据等信息方面有发布了大量文献资料和报告发表。为国内外企业、政府和科研机构提供咨询服务。连续多年为“中国化学制药工业协会”所著《医药发展蓝皮书》、《中国医药手册》作者之一；是《中国医药报》、《医药经济报》的特约撰稿人，在国内重要医药报刊发表大量文章。多次被邀请在中国医药行业大型会议和展览上做有关中国医药市场专题演讲。她的演讲以实际数据和案例阐明问题、总结变化规律，在中国制药企业中广为流传，受到医药界的好评。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:20-10:50 中国制药企业出海东南亚国家的案例分享嘉宾介绍王亚锋上海医药国际业务事业部东南亚区域负责人、上药泰国总经理中国药科大学本科，中欧国际工商学院Global EMBA。从事医药国际营销工作十余年，深厚的医药行业知识和专业能力。拥有丰富的海外子公司运营和营销团队管理经验。深度参与海外工厂立项，写字楼，仓库等绿地项目建设。海外常驻包括非洲加纳，尼日利亚，乌干达，科特迪瓦，东南亚泰国，菲律宾等多个国家。熟悉多个市场药政法规以及行业准入要求。多次在海外国家从零开始设立全资公司、合资公司，组建销售团队，实现业绩从零突破，运作药品进入国家用药指南和国家医保。所在团队曾实现单品种中国制剂出口第一。历任复星医药集团桂林南药国际商务代表，销售经理，海外国家经理，大区经理等，现任上海医药国际业务事业部东南亚区域负责人，上药泰国总经理。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:50-11:20 印度尼西亚制药业的机遇和市场开拓实践嘉宾介绍张君丽成都市一诺医药化工有限公司总经理采购总监公司团队深耕印尼市场十年，专注医药API等产品出口；聘请多名印尼本地员工，长期穿梭在印尼各个制剂工厂，拜访客户，与当地前十大药企均有超级深度的合作与链接！ 11:20-11:45 印尼清真医药产品市场情况更新嘉宾介绍 Dr. Ir. Muslich, M.Si Halal Partnership and Audit Services Director, LPPOM 获得IPB大学学士(S1)、研究生(S2)和博士(S3)学位;此前曾在多家私营公司工作(1991年至1993年)，PT TELKOM WITEL IX Jayapura农业和农用工业发展中心经理(1993年至1994年)，LPPOM MUI清真保证体系负责人(2010年至2015年)，QA和LPPOM MUI标准负责人(2015年至2019年)，LPPOM MUI高级顾问(2020年)，MUI清真认证要求开发团队负责人(2010年至2011年);现为IPB大学农业技术学院农业工业工程系讲师(自1994年起)，清真审核员(自1995年起)，清真管理体系标准制定技术委员会(SNI 99 001)成员，清真家禽屠宰场(SNI 99 002)，家庭切清真反刍(SNI 99 003)，清真食品(SNI 99 004)国家标准化机构(自2015年起)，SKKNI主管能力测试设备开发团队负责人Halal & SKKNI清真审核员(自2017年起)，国家认证机构能力评估员职业(BNSP)(自2015年起)，食品安全能力评估员，机构专业认证(LSP)食品质量保证与安全(JMKP)(自2015年起);于2020-2022年被任命为LPPOM MUI清真合作与审计服务总监。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 11:20-12:00 圆桌讨论：寻找东南亚市场的机会讨论嘉宾深圳市远邦医药有限公司湖南尔康制药股份有限公司成都倍特药业有限公司广州康臣药业有限公司 ...... 扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份把握东南亚市场发展机遇加速融入全球制药供应链随着东南亚医药市场的发展潜能进一步释放，中国医药企业将迎来更多发展机遇。作为中国药企链接国际市场的重要纽带，CPHI & PMEC 制药工业展（深圳）将携手400余家优质展商，共同探索企业在东南亚乃至全球市场的发展路径。下面就请跟随小编的步伐，一起走近本期的优选展商吧！浙江瑞邦药业股份有限公司展位：9F08 浙江瑞邦药业股份有限公司成立于1956年，具有60多年生产医药原料药和食品添加剂的生产经验。公司以药品生产质量管理规范（GMP) 标准组织生产和销售。本公司的产品获得了美国FDA，欧洲CEP和中国GMP的认证。主要产品有葡萄糖酸盐系列，莫匹罗星，莫匹罗星钙，环孢菌素，夫西地酸等。浙江瑞邦药业股份有限公司在国内外都享有良好的声誉。产品远销美国，欧洲，日本，印度及其他南美和东南亚地区。主推产品环孢菌素、莫匹罗星、莫匹罗星钙、葡萄糖酸钙、葡萄糖酸锌、葡萄糖酸钾、葡萄糖酸镁、葡萄糖酸亚铁、葡萄糖酸铜、葡萄糖酸锰、葡萄糖酸钠、多粘菌素B、夫西地酸、夫西地酸钠、米尔贝肟、葡萄糖酸内酯、非达霉素、甘草次酸、原儿茶酸。 ☝🏿☝🏿上下滑动查看完整展商介绍河北华晨药业集团有限公司展位：9D46 河北华晨药业集团有限公司，始建于1991年，坐落于黄骅经济开发区。是一家集研发、生产、销售药用包装材料、原料药、制剂、医疗器械，开展国内外贸易为一体的医药企业。集团公司现下设河北华晨药业有限公司、黄骅华宾生物科技有限公司、河北华迪药业有限公司、华晨吉海（北京）药物研究院。目前华晨药业拥有通过GMP认证的药用氯化钠、碳酸氢钠、氯化钾及新增制剂包括片剂、硬胶囊制剂、颗粒剂、散剂、软膏剂、凝胶贴膏剂、口服液等数十种，同时生产药用PE袋、膜、包装桶、瓶等药用包装材料等。主推产品氯化钠、碳酸氢钠、氯化钾、氯化钙、氯化铵、依地酸二钠、重酒石酸胆碱、富马酸（辅料、富马酸亚铁、醋酸钙、醋酸钠、硫酸镁、碘化钾、氯化镁、富马酸亚铁、葡萄糖酸锌、葡萄糖二酸钙、双乙酸钠、树脂再生剂、碳酸镧、硫酸钾、利多卡因、氟比洛芬、氯化镁、麝香草粉、盐酸利多卡因、葡萄糖酸钙、洛索洛芬钠、磷酸奥司他韦、无水硫酸钠、氨苯蝶啶、托匹司特、硫酸亚铁、西甲硅油、硫酸双肼屈嗪、甘羟鋁、葡萄糖酸亚铁、叔丁醇镁、异丙醇镁、二甲硅油、碳酸钙、亚硫酸镁（六水）、硫酸钾、乳酸钙、乳酸钠、乳果糖、丙胺卡因、喷托维林、丁卡因、双氯芬酸依泊胺、克立硼罗、阿达帕林、盐酸异丙嗪、高岭土、克罗米通、盐酸异丙嗪、氨苯蝶啶、叔丁醇镁、异丙醇镁、亚硫酸镁知名。 ☝🏿☝🏿上下滑动查看完整展商介绍山西阳和药业有限公司展位号：9A13 山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。主推产品乙酰半胱氨酸、间苯三酚、聚乙烯醇、间苯三酚三甲醚。 ☝🏿☝🏿上下滑动查看完整展商介绍浙江荣耀生物科技股份有限公司展位：9C51 浙江荣耀生物科技股份有限公司创立于1999年，位于台州湾经济技术开发区，是一家集研发、生产、销售于一体的创新型医药企业，是国家高新技术企业、浙江省专精特新中小企业、浙江省科技型中小企业。业务涵盖医药原料药及中间体、兽药原料药及中间体、CDMO等。主推产品二硝托胺148-01-6、甲砜霉素15318-45-3、氟苯尼考73231-34-2、非班太尔58306-30-2、芬苯达唑43210-67-9、莫昔克丁113507-06-5、赛拉菌素220119-17-5、氟雷拉纳864731-61-3、奥拉替尼1208319-26-9、2-氨基-N-(2、2、2-三氟乙基)乙酰胺盐酸盐1171331-39-7、三氯苯达唑68786-66-3、癸氧喹酯18507-89-6、尼卡巴嗪330-95-0、3′、5′-二氯-2、2、2-三氟苯乙酮130336-16-2、4-氯吡咯并嘧啶3680-69-1、反式-N-甲基-[4-(甲氨基)环己基]甲磺酰胺1809995-95-6、依帕司他82159-09-9、盐酸氨溴索23828-92-4、盐酸金刚乙胺1501-84-4、盐酸溴己新611-75-6、西司他丁82009-34-5、3-甲基-6-硝基-1H-吲唑6494-19-5、2-[4-(2-吡啶基)苄基]-肼羧酸叔丁酯198904-85-7、2-氨基-1-(2、5-二甲氧基苯基)乙醇3600-87-1、3-(三氟甲基)-5、6、7、8-四氢-[1、2、4]三唑并[4、3-a]吡嗪盐酸盐762240-92-6、(3S、4R)-4-(4-氟苯基)-1-甲基-3-哌啶甲醇105812-81-5、1-(4-氨基苯基)环戊甲腈115279-73-7、3-氨基-1-金刚烷醇702-82-9、1-金刚烷甲酸828-51-3、2-金刚烷酮700-58-3、1-金刚烷胺768-94-5、1-金刚烷甲醇770-71-8、2-金刚烷醇700-57-2、1-金刚烷醇768-95-6。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏宇田医药有限公司展位：9E31 江苏宇田医药有限公司是一家从事现代医药研发、生产、销售为一体的新型特色API及CDMO制药企业，致力于为国内各大制药企业提供高质量的原料药与中间体，公司产品同时远销欧洲、日韩、印度等数十个国家，为国家重点高新技术企业、市科技小巨人企业、中华药港新医药产业基地骨干企业之一。宇田医药始终把科研开发作为企业可持续发展的支撑力量，是国内科研投入较多的药企之一，公司以连云港研发中心为科研载体，配合杭州科巢生物科技、连云港万科生物科技、黑龙江迪诺医药，自主创新能力不断增强。形成了“以一带三”的良性格局。宇田医药在江苏连云港、黑龙江佳木斯建有两个生产基地，获得国家高新技术企业、省级工程技术研究中心、江苏省瞪羚企业、江苏省科技型中小企业、安全标准化二级企业、省两化融合示范试点企业，同时也获得了原料药品种的GMP和注册现场核查的二合一认证，先后承担省/市级成果转换等多个省/市级科技项目；获得授权专利与商标数十项；通过ISO9000、ISO14000认证。这些荣誉的取得标志着企业药品生产质量和管理水平走在了全国医药行业前列。主推产品原料药：碘克沙醇、碘海醇、阿托伐他汀钙、瑞舒伐他汀钙、盐酸伊伐布雷定、利奈唑胺、西洛多辛、盐酸厄洛替尼、盐酸莫西沙星及各中间体。中间体：造影剂系列中间体、多尼培南侧链、比阿培南侧链、1,4-丁二磺酸。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏同禾药业有限公司展位：9D26 江苏同禾药业有限公司是江苏万兴创业投资有限公司的全资子公司，是一家集制剂药、原料药和保健食品的研发、生产、销售为一体的国家高新技术企业。连续8年，跻身于常熟市百强企业前50 名。公司拥有原料药、片剂、胶囊剂和颗粒剂的GMP证书。硫辛酸、6.8-二氯辛酸乙酯、右旋硫辛酸钠、环丙贝特、10-甲氧基亚氨基芪等多个产品被评为江苏省高新技术产品；硫辛酸、盐酸二甲双胍等取得了原料药品批件，厄多司坦片、氨酚伪麻分散片和新雪胶囊等取得药品注册批件和新药证书；硫辛酸片和胶囊即将取得新药证书，另有10多个新药正在SFDA审批中。调节血糖和控制并发症的保健食品唐苹片正在全国热销中。主推产品硫辛酸系列、右旋硫辛酸、右旋硫辛酸钠盐、右旋硫辛酸氨基丁三醇盐。 ☝🏿☝🏿上下滑动查看完整展商介绍 CPHI & PMEC 制药工业展（深圳）致力于打造国际化制药产业生态圈，汇集产业链上下游实力企业，以技术驱动产业提升，助推更多中国药企扬帆“出海”，聚势共赢！扫描二维码 0元领票 8月30日前完成预登记现场可领取电子会刊一份金秋九月·不见不散！联系我们参观咨询林女士电话：021-33392105 邮箱：ashley.lin@imsinoexpo.com 张女士电话：010-58036315 邮箱：zhangyuanyuan@cccmhpie.org.cn 参展咨询茅女士电话：021-33392250 邮箱：chris.mao@imsinoexpo.com 吴女士电话：010-58036296 邮箱：wuyushuang@cccmhpie.org.cn 👇点击“阅读原文”，免费领取展会参观门票！！

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100 项与双氯芬酸依泊胺相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	双氯芬酸依泊胺	M02AB	-

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适应症	国家/地区	公司	日期
急性疼痛	美国	IBSA Institut Biochimique SA	2007-01-31

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适应症	最高研发状态	国家/地区	公司	日期
挫伤	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
疼痛	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
扭伤和拉伤	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
软组织损伤	临床3期	美国	IBSA Institut Biochimique SA	2021-10-31
膝关节炎	临床前	美国	Virpax Pharmaceuticals, Inc.	2022-03-22

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临床结果

适应症

分期

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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


NCT02324270 (CTgov)	临床3期	急性疼痛 \| 踝损伤	658	Placebo	壓簾願築遞蓋鹹製艱齋(餘製範醖範餘糧醖鹹遞) = 衊齋願簾淵蓋願鏇顧遞膚構襯網鬱積鬱願遞願 (襯醖鑰襯糧鏇鏇願壓憲, 憲糧夢糧衊齋觸夢製壓 ~ 獵鬱遞膚廠蓋顧夢蓋築) 更多	-	2020-06-24
NCT03145259 (CTgov)	早期临床1期	-	12	Diclofenac Epolamine (Diclofenac Epolamine Patches)	壓繭襯簾夢淵願鏇鏇網(鏇繭顧淵觸艱築壓積廠) = 積淵鏇襯艱簾膚鏇鑰衊蓋鹽蓋鏇壓獵願願淵繭 (夢鹽襯窪願顧憲膚顧選, 膚壓膚鹹選夢範鹹鑰鏇 ~ 鹽積獵糧衊願糧糧鏇選) 更多	-	2020-06-16
				Diclofenac Sodium (Diclofenac Sodium Solution)	壓繭襯簾夢淵願鏇鏇網(鏇繭顧淵觸艱築壓積廠) = 壓觸顧艱憲鹽衊範鏇鬱蓋鹽蓋鏇壓獵願願淵繭 (夢鹽襯窪願顧憲膚顧選, 艱顧淵繭選齋顧觸鹽淵 ~ 選築蓋蓋顧選夢餘鏇鬱) 更多
NCT02132247 (CTgov)	临床4期	软组织损伤 \| 运动损伤	104	Flector (Flector Patch/Age 6-11)	糧繭糧醖鹹廠鑰獵襯膚(淵壓積築壓窪鹹鬱鹹餘) = 齋選餘鏇廠遞襯淵淵鑰鹽製製衊廠餘襯積淵鹽 (網顧膚淵鹹壓糧艱遞蓋, 積鹽齋齋鹽鬱鏇鏇築廠 ~ 範壓顧蓋窪選淵壓繭醖) 更多	-	2018-05-11
				Flector (Flector Patch/Age 12-16)	糧繭糧醖鹹廠鑰獵襯膚(淵壓積築壓窪鹹鬱鹹餘) = 鏇願製積蓋構遞餘選糧鹽製製衊廠餘襯積淵鹽 (網顧膚淵鹹壓糧艱遞蓋, 鹹製願獵鹹壓鑰積選選 ~ 獵壓醖糧繭齋鹹衊鬱範) 更多