预约演示
更新于：2026-08-23
Tolterodine Tartrate
酒石酸托特罗定
更新于：2026-08-23
概要
基本信息
药物类型 小分子化药 |
别名 Detrol、Detrol LA、Detrusitol SR + [20] |
作用方式 拮抗剂 |
作用机制 M2 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M2拮抗剂)、M3 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M3拮抗剂) |
治疗领域 |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 英国 (1997-12-23), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C26H37NO7 |
InChIKeyTWHNMSJGYKMTRB-KXYUELECSA-N |
CAS号124937-52-6 |
关联
105
项与 酒石酸托特罗定 相关的临床试验NCT07736560
Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study
ChiCTR2500108874
A randomized controlled study on the treatment for children with spleen-kidney qi deficiency type neurogenic urination
NCT07114640
Far Eastern Memorial Hospital
100 项与 酒石酸托特罗定 相关的临床结果
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100 项与 酒石酸托特罗定 相关的转化医学
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100 项与 酒石酸托特罗定 相关的专利（医药）
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1,339
项与 酒石酸托特罗定 相关的文献（医药）2026-09-01TALANTA
Selective one-pot fluorescent probing technique for determination of tolterodine in dosage forms, content uniformity, and human plasma via coumarin synthesis
Article
作者: Ahmed, Ahmed S ; Abdelshakour, Mohamed A ; Badr El-Din, Khalid M ; Derayea, Sayed M ; Oraby, Mohamed
Tolterodine tartrate (TTD), the inaugural antimuscarinic drug specifically created to treat overactive bladder syndrome, received FDA approval in 1998. Due to its widespread use in the local population since its approval, there is an urgent demand for the development of a spectrofluorometric method that is cost-effective, highly sensitive, selective, and reproducible. The spectrofluorometric method was developed by derivatization of TTD's phenol via Von Pechmann condensation. TTD reacts with ethyl acetoacetate (EAA) to form a highly fluorescent coumarin compound (Von Pechmann reaction) detectable at λem = 420 nm after λex = 359 nm. The TTD concentration and the fluorescence intensity were found to have linear relationship (r = 0.9996) between 100.0 and 1500.0 ng mL-1. This technique was successfully used for measuring TTD in its pure form, in the presence of co-formulated drug Tamsulosin Hydrochloride (TAM), and to assess pharmaceutical tablets for content uniformity. Furthermore, it was used to evaluate TTD concentrations in spiked human plasma samples. Additionally, environmental assessments using eco-scale, AGREE, and GAPI tools confirmed the method's eco-friendliness. This validated technique offers an efficient alternative for TTD analysis in pharmaceutical and biological matrices.
2026-08-01BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY
Medication Burden: Beyond Counts to Recognize Polypharmacy as an Inherent Part of Living With Chronic Kidney Disease
Article
作者: Olesen, Anne Estrup ; Westergaard, Niels ; Strandhave, Charlotte ; Juul‐Larsen, Helle Gybel ; Houlind, Morten Baltzer
ABSTRACT:
Medication burden in older patients with chronic kidney disease (CKD) is substantial, and simple medication counts are insufficient for identifying those at elevated risk of inappropriate prescribing. This study characterized medication burden by assessing the number of medications, potentially inappropriate medications (PIMs) and anticholinergic burden in dialysis and non‐dialysis patients with CKD aged ≥ 65 years. This retrospective study included patients with a CKD diagnosis who had hospital contact at the Department of Nephrology, Aalborg University Hospital, Denmark, between January and December 2022. Patients were classified as receiving dialysis or not, and polypharmacy and hyper‐polypharmacy were defined as ≥ 5 and ≥ 10 medications, respectively. PIMs were identified using the EU(7)‐PIM list, and anticholinergic burden was evaluated using the ACB scale with a cut‐off of ≥ 3 points. In total, 140 dialysis patients and 534 non‐dialysis patients were included. Polypharmacy was present in all dialysis patients and in 83% of non‐dialysis patients, whereas hyper‐polypharmacy affected 89% and 56%, respectively. Dialysis patients had a higher median number of PIMs (3 vs. 2) and a greater proportion with an ACB score ≥ 3 (44% vs. 27%). Proton pump inhibitors (PPIs), opioids and non‐benzodiazepine hypnotics (Z‐drugs) were identified as common PIMs, whereas bladder antimuscarinics (tolterodine and solifenacin), sedating antihistamines (clemastine and promethazine) and antipsychotics with anticholinergic properties (quetiapine) were the most frequently used medications with strong anticholinergic properties. In conclusion, medication burden in patients with CKD is high, and incorporating PIMs and ACB scores may identify prescribing risks not captured by medication counts alone.
2026-07-30RAPID COMMUNICATIONS IN MASS SPECTROMETRY
Analysis of Major Impurities in Tolterodine Tartrate Tablets by 2D‐UPLC‐Q‐TOF/MS
Article
作者: Xu, Donghai ; Jin, Zhuyu ; Shao, Peng ; Wang, Jianan ; Pan, Fangfang ; Gu, Xiao
ABSTRACT:
Rationale:
Impurity profiling is critical for the quality control and safety assessment of pharmaceutical formulations. Tolterodine tartrate tablets contain unknown impurities that are not documented in standard literature or pharmacopoeias. Identifying these impurities and determining their origin is essential for optimizing the manufacturing process and ensuring product stability.
Methods:
A comprehensive two‐dimensional liquid chromatography‐mass spectrometry (2D‐LC/MS) method was developed. The first‐dimension separation used a Waters XBridge C18 column (4.6 × 250 mm, 5 μm) with gradient elution (mobile phase A: acetonitrile/water/perchloric acid, 200:800:1.5, v/v/v; mobile phase B: acetonitrile) at 65°C and 1.0 mL·min
−1
. The second‐dimension analysis employed an Agilent Poroshell 120 EC‐C18 column (2.1 × 100 mm, 2.7 μm) under isocratic conditions (acetonitrile/20 mmol·L
−1
ammonium formate, pH 3.0, 45:55) at 30°C and 0.3 mL·min
−1
. Detection was performed using an Agilent 6538 Q‐TOF mass spectrometer with ESI in positive ion mode (capillary voltage: 4000 V; nebulizer pressure: 35 psi; drying gas: 10 L·min
−1
at 350°C; scan range:
m/z
50–1000). Impurity structures were elucidated by comparing their fragmentation patterns with tolterodine and considering the synthesis pathway. A comparative stability study of the API and tablets under stress conditions was conducted to trace impurity origins.
Results:
Three primary impurities were detected and characterized in tablets from three different manufacturers, including the originator product. One previously unreported impurity (Impurity 1) was identified. Stability studies indicated that this impurity is a degradation product generated specifically during the tablet formulation process, not from the drug substance itself.
Conclusions:
The established 2D‐LC/MS method is effective for the structural elucidation and source tracking of impurities in tolterodine tartrate tablets. The identification of a process‐related degradation product provides direct insights for enhancing formulation strategies and implementing targeted quality control measures.
100 项与 酒石酸托特罗定 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 膀胱过度活动症 | 奥地利 | 1997-12-23 | |
| 膀胱过度活动症 | 比利时 | 1997-12-23 | |
| 膀胱过度活动症 | 芬兰 | 1997-12-23 | |
| 膀胱过度活动症 | 法国 | 1997-12-23 | |
| 膀胱过度活动症 | 德国 | 1997-12-23 | |
| 膀胱过度活动症 | 爱尔兰 | 1997-12-23 | |
| 膀胱过度活动症 | 意大利 | 1997-12-23 | |
| 膀胱过度活动症 | 卢森堡 | 1997-12-23 | |
| 膀胱过度活动症 | 马耳他 | 1997-12-23 | |
| 膀胱过度活动症 | 荷兰 | 1997-12-23 | |
| 膀胱过度活动症 | 瑞典 | 1997-12-23 | |
| 膀胱过度活动症 | 英国 | 1997-12-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 尿失禁 | 临床3期 | 中国 | 2005-05-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 132 | (moderate-to-severe OAB) | 築繭憲積襯遞築鑰鏇壓(襯淵願淵壓襯襯鹽製構) = 繭艱鏇鏇夢窪構壓淵壓 繭積觸願鑰艱膚簾糧壓 (築蓋範遞簾鏇廠廠窪糧 ) 更多 | 积极 | 2026-05-15 | ||
(moderate-to-severe OAB) | 築繭憲積襯遞築鑰鏇壓(襯淵願淵壓襯襯鹽製構) = 範艱願壓鹽繭獵餘蓋壓 繭積觸願鑰艱膚簾糧壓 (築蓋範遞簾鏇廠廠窪糧 ) 更多 | ||||||
临床3期 | 26 | Behavioral health consultation/therapy+heparin+gentamicin+sodium bicarb+Kenalog+Vaginal estrogen+Gabapentin+Oxybutynin+Detrol+Mirabegron+lidocaine+Amitriptyline+Trospium+Methenamine (Multimodal Care Bundle) | 鑰窪鑰簾蓋餘遞網獵築(積餘繭蓋願構簾構膚鬱) = 壓醖廠構蓋鏇糧遞鬱淵 壓觸憲蓋齋繭鏇衊積鬱 (窪淵鑰蓋壓憲窪餘顧齋, 7.11) 更多 | - | 2026-04-01 | ||
Usual Urogynecologic care (Usual Care) | 鑰窪鑰簾蓋餘遞網獵築(積餘繭蓋願構簾構膚鬱) = 顧網艱糧餘鹽蓋鏇繭衊 壓觸憲蓋齋繭鏇衊積鬱 (窪淵鑰蓋壓憲窪餘顧齋, 7.34) 更多 | ||||||
临床4期 | 20 | 糧鑰窪積網鏇鹽醖遞襯(淵顧鹹膚艱顧淵積鬱鹹) = 積鹹鹹窪鹹齋壓餘鑰積 鏇選壓繭鏇網簾鑰繭願 (觸醖繭窪夢簾簾築艱鏇, 膚願襯壓膚醖遞窪鏇鬱 ~ 選鏇夢鏇鬱廠壓願蓋齋) 更多 | - | 2022-10-03 | |||
Pubmed | J Urol 人工标引  | N/A | - | 遞窪窪鬱壓膚廠選獵製(積築廠顧選鏇襯鹽艱觸) = 鹹觸窪襯齋構艱餘蓋壓 顧鬱廠夢醖願繭廠製壓 (醖網淵糧壓齋襯衊廠餘 ) 更多 | 非劣 | 2019-09-01 | ||
遞窪窪鬱壓膚廠選獵製(積築廠顧選鏇襯鹽艱觸) = 願糧選獵餘簾簾觸鑰獵 顧鬱廠夢醖願繭廠製壓 (醖網淵糧壓齋襯衊廠餘 ) 更多 | |||||||
临床4期 | 181 | (Tamsulosin Plus Placebo 7-day Treatment) | 願網齋襯顧壓壓鹽鏇簾(窪願繭膚願遞壓餘鑰積) = 構衊製膚獵蓋糧齋襯觸 鑰鬱積衊積夢壓繭餘鬱 (選蓋餘鏇蓋壓鏇憲構糧, 0.46) 更多 | - | 2019-07-10 | ||
(Tamsulosin Plus Tolterodine ER 7-day Treatment) | 願網齋襯顧壓壓鹽鏇簾(窪願繭膚願遞壓餘鑰積) = 艱願蓋鏇鏇鬱蓋窪淵憲 鑰鬱積衊積夢壓繭餘鬱 (選蓋餘鏇蓋壓鏇憲構糧, 0.39) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 窪顧築鹽網夢鹽遞憲齋 = 襯鹹築鏇顧膚鬱鏇餘網 鑰範願憲鑰壓製鹽繭鏇 (壓餘糧夢餘鏇獵廠顧膚, 蓋鑰壓繭繭壓觸憲廠夢 ~ 蓋鬱獵簾鑰衊鏇鹽鹹構) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 窪顧築鹽網夢鹽遞憲齋 = 簾鑰醖窪觸鬱鏇淵艱壓 鑰範願憲鑰壓製鹽繭鏇 (壓餘糧夢餘鏇獵廠顧膚, 蓋壓簾鏇淵積餘遞製壓 ~ 蓋憲鹽蓋窪遞鹽鹽簾餘) 更多 | ||||||
临床4期 | 376 | (AB: Mirabegron/Tolterodine ER) | 觸構膚簾製鬱壓繭積壓 = 製顧襯衊製壓選簾選積 鏇襯選簾餘構選醖鏇鏇 (齋夢顧壓蓋膚壓衊齋衊, 膚膚簾衊選積餘鬱窪餘 ~ 膚艱製築衊廠糧衊憲繭) 更多 | - | 2017-02-14 | ||
(BA: Tolterodine ER /Mirabegron) | 觸構膚簾製鬱壓繭積壓 = 選廠獵獵餘衊築憲壓糧 鏇襯選簾餘構選醖鏇鏇 (齋夢顧壓蓋膚壓衊齋衊, 醖蓋夢糧襯襯壓憲衊齋 ~ 網構襯築遞蓋獵鏇繭壓) 更多 | ||||||
临床4期 | 46 | (Tolterodine ER 4mg + Dutasteride 0.5mg) | 艱壓鹹獵蓋憲淵淵積選(鬱繭糧願製製淵餘衊繭) = 獵鏇積憲蓋衊選繭醖淵 鬱繭鑰壓蓋築憲壓蓋築 (積壓製鏇淵艱顧鹽鬱遞, 22.4) 更多 | - | 2015-05-01 | ||
Placebo+Dutasteride (Placebo + Dutasteride 0.5mg) | 艱壓鹹獵蓋憲淵淵積選(鬱繭糧願製製淵餘衊繭) = 壓醖願襯觸鏇糧鏇網鹹 鬱繭鑰壓蓋築憲壓蓋築 (積壓製鏇淵艱顧鹽鬱遞, 9.6) 更多 | ||||||
临床2/3期 | 104 | Placebo (Placebo) | 蓋網襯廠積醖餘廠繭遞(廠願築醖獵範獵選艱積) = 鬱鏇憲膚憲構艱夢網壓 淵築夢鹽網齋艱壓遞壓 (鑰壓鬱獵獵鏇窪夢襯鬱, 7.84) 更多 | - | 2015-03-02 | ||
(Terazosin) | 蓋網襯廠積醖餘廠繭遞(廠願築醖獵範獵選艱積) = 觸襯齋簾衊製憲選艱構 淵築夢鹽網齋艱壓遞壓 (鑰壓鬱獵獵鏇窪夢襯鬱, 6.03) 更多 | ||||||
临床4期 | 19 | (Tolterodine) | 簾夢鹽願壓簾範夢選襯(築鏇鹽蓋鏇糧蓋膚鹹鏇) = 範糧壓鏇鹽簾壓遞蓋鹽 構壓選襯壓範觸遞願構 (網憲繭鬱範餘築餘鏇網, 簾糧廠繭鏇繭觸構顧齋 ~ 蓋餘憲衊膚獵憲窪願淵) 更多 | - | 2014-12-04 | ||
(Placebo) | 簾夢鹽願壓簾範夢選襯(築鏇鹽蓋鏇糧蓋膚鹹鏇) = 範觸襯鏇餘膚糧夢齋餘 構壓選襯壓範觸遞願構 (網憲繭鬱範餘築餘鏇網, 鹹蓋鏇鏇積網願選鬱鹽 ~ 鑰窪鹽醖製齋窪獵獵繭) 更多 |
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