预约演示
更新于：2025-02-07
Diclofenac Epolamine
双氯芬酸依泊胺
更新于：2025-02-07
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 法国 (2003-05-28) |
最高研发阶段(中国)临床3期 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C20H24Cl2N2O3 |
InChIKeyDCERVXIINVUMKU-UHFFFAOYSA-N |
CAS号119623-66-4 |
关联
21
项与 双氯芬酸依泊胺 相关的临床试验CTR20244366
双氯芬酸依泊胺凝胶贴膏人体生物等效性研究
CTR20241517
双氯芬酸依泊胺贴在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
CTR20232884
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
100 项与 双氯芬酸依泊胺 相关的临床结果
登录后查看更多信息
100 项与 双氯芬酸依泊胺 相关的转化医学
登录后查看更多信息
100 项与 双氯芬酸依泊胺 相关的专利（医药）
登录后查看更多信息
106
项与 双氯芬酸依泊胺 相关的文献（医药）2023-10-01Pain 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.
2022-11-01Biomaterials advances
Effect of microneedles shape on skin penetration and transdermal drug administration
Article
作者: Palladino, Antonio ; Amendola, Eugenio ; De Martino, Selene ; Napolitano, Francesco ; Serpico, Luigia ; De Stefano, Luca ; Squillace, Antonino ; De Girolamo, Paolo ; Battisti, Mario ; Martone, Alfonso ; Dardano, Principia ; Dello Iacono, Stefania
Microneedle (MN) patches are highly efficient and versatile tools for transdermal drug administration, in particular for pain-free, self-medication and rapid local applications. Diffraction ultraviolet (UV) light lithography offers an advanced method in fabricating poly(ethylene glycol)-based MNs with different shapes, by changing both the UV-light exposure time and photomask design. The exposure time interval is limited at obtaining conical structures with aspect ratio < 1:3, otherwise MNs exhibit reduced fracture load and poor indentation ability, not suitable for practical application. Therefore, this work is focused on a systematic analysis of the MN's base shapes effects on the structural characteristics, skin penetration and drug delivery. Analyzing four different base shapes (circle, triangle, square and star), it has been found that the number of vertices in the polygon base heavily affects these properties. The star-like MNs reveal the most efficient skin penetration ability (equal to 40 % of -their length), due to the edges action on the skin during the perforation. Furthermore, the quantification of the drug delivered by the MNs through ex-vivo porcine skin shows that the amounts of small molecules released over 24 h by star-like MNs coated by local anesthetic (Lidocaine) and an anti-inflammatory (Diclofenac epolamine) drugs are 1.5× and 2× higher than the circular-MNs, respectively.
2022-10-01Pharmaceutical 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.
100 项与 双氯芬酸依泊胺 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 急性疼痛 | 美国 | 2007-01-31 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 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 | 2023-11-15 | |
| 疼痛 | 临床3期 | 中国 | 2023-11-15 | |
| 扭伤和拉伤 | 临床3期 | 中国 | 2023-11-15 | |
| 软组织损伤 | 临床3期 | 美国 | 2021-10-31 | |
| 膝关节炎 | 临床前 | 美国 | 2022-03-22 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 658 | Placebo | 鏇衊齋齋築窪蓋鏇窪壓(願鹹餘願壓選鬱衊鹹蓋) = 鑰餘積齋鹽網鬱廠衊膚 壓餘淵淵膚網蓋簾淵餘 (製夢糧糧獵蓋膚憲壓構, 窪範觸齋網顧壓膚夢襯 ~ 顧願顧獵窪壓艱糧餘鹹) 更多 | - | 2020-06-24 | ||
早期临床1期 | - | 12 | (Diclofenac Epolamine Patches) | 蓋憲築淵鬱鏇鹽獵壓廠(醖壓顧選膚齋顧蓋鑰糧) = 衊構膚窪憲積鹹襯鏇願 鏇積積餘繭餘廠鹽積鏇 (製窪遞餘憲廠鹽繭獵醖, 鹽鬱鹹鏇鹽積製顧網壓 ~ 簾範願膚選鹽願齋餘窪) 更多 | - | 2020-06-16 | |
(Diclofenac Sodium Solution) | 蓋憲築淵鬱鏇鹽獵壓廠(醖壓顧選膚齋顧蓋鑰糧) = 窪願選齋廠艱鏇遞範廠 鏇積積餘繭餘廠鹽積鏇 (製窪遞餘憲廠鹽繭獵醖, 壓糧蓋襯網糧製鹽艱醖 ~ 糧醖獵鹽繭鬱憲膚窪餘) 更多 | ||||||
临床4期 | 104 | (Flector Patch/Age 6-11) | 簾餘鹹築簾製簾餘醖糧(製齋鏇積繭鏇淵獵簾蓋) = 鏇願餘壓廠鏇構範簾選 襯憲醖襯築製選遞憲廠 (簾鏇鹹鑰艱膚遞憲顧膚, 餘鹽鑰衊遞淵網簾遞窪 ~ 憲鬱鬱鑰糧範鑰窪顧鑰) 更多 | - | 2018-05-11 | ||
(Flector Patch/Age 12-16) | 簾餘鹹築簾製簾餘醖糧(製齋鏇積繭鏇淵獵簾蓋) = 膚餘範窪鹹積艱鏇鹹鹹 襯憲醖襯築製選遞憲廠 (簾鏇鹹鑰艱膚遞憲顧膚, 築觸窪膚願壓糧觸糧製 ~ 醖積齋選餘積壓膚壓顧) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用