更新于：2024-12-09
Brinzolamide
布林佐胺
更新于：2024-12-09
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C12H21N3O5S3 |
InChIKeyHCRKCZRJWPKOAR-JTQLQIEISA-N |
CAS号138890-62-7 |
关联
35
项与 布林佐胺 相关的临床试验A Randomized, Double-masked, Active Controlled, Parallel Group, Two-arm, Multi Center,in-vivo Bioequivalence Study with Clinical Endpoint Comparing Brinzolamide OphthalmicSuspension, USP 1 Percent of Riconpharma LLC, USA to AZOPT® (Brinzolamide OphthalmicSuspension) 1 Percent of Novartis Pharmaceuticals Corporation, USA in subjects with Chronic OpenAngle Glaucoma or Ocular Hypertension in both eyes - Nil
A multicenter, randomized, assessor-blinded, active controlled, parallel group, two arm, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml + Brimonidine tartrate 2 mg/ml eye drops suspension (AZAD Pharma AG, Switzerland) and Simbrinza® (Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland ) in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.
A prospective, phase III, multicenter, randomized, investigator-blinded, two-arm, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml eye drops suspension (Brinzolamide 10mg/ml Eye Drops Suspension Preservative Free) as a test product versus AZOPT® 10 mg/ml eye drops suspension as reference product in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension
100 项与 布林佐胺 相关的临床结果
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100 项与 布林佐胺 相关的转化医学
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100 项与 布林佐胺 相关的专利（医药）
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453
项与 布林佐胺 相关的文献（医药）2025-01-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Oxidative stress-induced degradation of Brinzolamide: Isolation and in-depth characterization of unique hydroxylamine and oxime degradation products
Article
作者: Modini, Arun Kumar ; Ranga, Mahesh ; Doddipalla, Raju ; Kaliyaperumal, Muralidharan ; Goswami, Anandarup
Since the safety and efficacy of therapeutic products are strongly related to their stability and purity, impurities including the unavoidable degradation products may affect the pharmacological effect. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines Q3A requires the identification of process impurities and as well as degradation products in any drug substance to assess the inherent stability of the drug. The present work involves an ICH-guided degradation study for the Brinzolamide (BRZ), a topical ophthalmic drug which is generally used to lower the intraocular pressure (IOP) during glaucoma. Under oxidative stress at room temperature for 20 h, four degradation products (namely BRZ-Pk1, BRZ-PK2, BRZ-Pk3, and BRZ-Pk4) are isolated using advanced chromatographic techniques. Upon confirming the masses of the compounds using High-resolution mass spectrometry (HRMS), functional groups are identified with the help of Fourier-transform infrared spectroscopy (FT-IR). Extensive 1-dimensional (1D) and 2-dimensional (2D) Nuclear Magnetic Resonance spectroscopic (NMR) experiments especially 1D nOe, 1H-13C-HSQC and 1H-13C-HMBC unequivocally confirm the structures. Among the four compounds analyzed, three (BRZ-Pk1, BRZ-Pk2, and BRZ-Pk4) are novel, while BRZ-Pk3 was previously reported solely with mass spectrometric data. Nitrogen-based 2D NMR experiments are crucial for determining the oxidation state of hydroxylamine and oxime products within the molecules, and 1D nOe measurements help confirming E/Z isomerism (geometrical isomerism) for BRZ-Pk2 and BRZ-Pk4. All the proposed structures are justified with appropriate analytical data. The proposed mechanisms are expected to help in identifying the possible degradation pathways for similar pharmaceutical candidates.
2025-01-01JOURNAL OF CONTROLLED RELEASE
Active trans-corneal drug delivery with ocular adhesive micelles for efficient glaucoma therapy
Article
作者: Yuan, Guiping ; Wei, Qiuyu ; Shao, Shiqun ; Fan, Wufa ; Jin, Jiahui ; Zhu, Chenchen ; Shen, Youqing ; Lin, Sen ; Xiang, Jiajia ; Piao, Ying ; Zhang, Jing
Efficient and noninvasive drug delivery for glaucoma therapy necessitates prolonged retention on the ocular surface and deep penetration into the cornea. However, inherent physiological defenses such as rapid tear clearance and low cornea permeability present significant challenges that hinder the effectiveness of trans-corneal drug delivery. In this study, we demonstrate the potential of zwitterionic micelles composed of poly(2-(N-oxide-N,N-diethylamino)ethyl methacrylate)-block-poly(ε-caprolactone) (OPDEA-PCL) amphiphiles as a biocompatible carrier for trans-corneal drug delivery. These micelles exhibit enhanced adhesion to ocular tissues and resistance to tear clearance due to their unique affinity for cell membranes. These characteristics facilitate adsorptive-mediated transcytosis, significantly augmenting trans-corneal transport and intraocular accumulation of the glaucoma medication brinzolamide (BRZ). As a result, OPDEA-PCL/BRZ formulations effectively normalize intraocular pressure in an open-angle glaucoma rat model, surpassing PEGylated and free BRZ formulations. This research underscores the potential utility of OPDEA-PCL micelles as a promising vehicle for noninvasive topical trans-corneal drug delivery in glaucoma therapy.
2024-12-01American journal of ophthalmology case reports
A case of delayed recurrent hyphema following Implantable Collamer Lens (ICL) surgery
Article
作者: Wan, Wenjuan ; Zuo, Hangjia ; Zheng, Shijie ; Chen, Hong ; Lin, Meiting ; Chen, Yonglin ; Cheng, Hong ; Hu, Ke
Purpose:
To present a case of delayed recurrent hyphema following toric ICL implantation.
Observations:
This case reports a 24-year-old Asian female who presented with sudden decrease in vision in the right eye, accompanied by recurrent massive anterior chamber hemorrhage, six months after bilateral implantation of toric ICL with central holes for myopia correction. Despite initial conservative treatment with immobilization and intraocular pressure (IOP)-lowering medication at another hospital, the hyphema persisted. At our hospital, her corrected visual acuity (CDVA) in the right eye was counting fingers (CF) at 50 cm, with visible blood clots and hyphema in the anterior chamber, and an IOP of 40 mmHg. Ultrabiomicroscopy (UBM) indicated a large amount of hyphema in the anterior chamber. Initially, the patient was treated with a combination of three IOP-lowering medications: brimonidine eye drops, brinzolamide eye drops, and timolol eye drops, but the condition recurred. Two weeks later, we performed an anterior chamber hyphema evacuation and ICL removal surgery in the right eye. Postoperatively, the patient's IOP stabilized and her vision gradually recovered. One month after the surgery, a follow-up examination showed a CDVA of LogMAR 0.6 in the affected eye.
Conclusion and importance:
This case report is essential for characterizing a rare and serious complication following toric ICL implantation, highlighting the importance of close monitoring and timely intervention.
100 项与 布林佐胺 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 青光眼 | 日本 | 2002-12-10 | |
| 开角型青光眼 | 美国 | 1998-04-01 | |
| 高眼压症 | 美国 | 1998-04-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 599 | (BRIN-20-01) | 衊獵鹹範膚願鏇醖觸遞(廠壓製窪顧窪齋觸憲觸) = 廠網鬱憲齋製簾積壓範 構艱構築觸構醖鹽觸鑰 (襯憲膚衊鬱壓願齋構廠, 鹹鏇糧鬱蓋壓築鑰鑰鏇 ~ 壓選廠顧餘醖憲願蓋鏇) 更多 | - | 2024-01-18 | ||
(Azopt®) | 衊獵鹹範膚願鏇醖觸遞(廠壓製窪顧窪齋觸憲觸) = 艱窪獵鹹鏇醖淵蓋糧鑰 構艱構築觸構醖鹽觸鑰 (襯憲膚衊鬱壓願齋構廠, 艱淵夢簾積鑰壓憲繭構 ~ 糧簾艱憲蓋築鏇憲膚鹽) 更多 | ||||||
N/A | 一线 | - | OcuSurf-BZ | 範繭鹽糧觸憲觸壓顧淵(窪願築夢夢蓋糧製願淵) = 繭積鬱襯範築衊艱鏇醖 壓鑰觸構鏇蓋餘觸齋憲 (壓糧鏇鬱繭獵淵網淵醖 ) | - | 2023-04-23 | |
临床3期 | 495 | (Perrigo Active) | 積繭醖夢選積繭網鹽願(膚願憲鬱鬱獵構鹽蓋積) = 顧壓鬱簾襯鏇鏇齋鑰艱 艱廠網鬱壓繭醖齋獵遞 (餘淵遞築憲鏇醖壓憲衊, 膚遞範窪膚遞餘鬱膚積 ~ 餘鹹廠鹽衊鹹壓齋夢網) 更多 | - | 2023-03-06 | ||
(Reference Active) | 積繭醖夢選積繭網鹽願(膚願憲鬱鬱獵構鹽蓋積) = 製糧糧鏇鏇製構遞膚鹹 艱廠網鬱壓繭醖齋獵遞 (餘淵遞築憲鏇醖壓憲衊, 醖網夢襯構積積選衊遞 ~ 簾願鬱膚觸製蓋繭築遞) 更多 | ||||||
临床1/2期 | 637 | (Brinzolamide 1% Ophthalmic Suspension) | 衊鑰遞積築蓋鏇範糧襯(膚顧艱艱鹽襯選繭壓艱) = 構選構鬱膚觸鑰築鹽網 獵簾蓋膚廠鹽繭願鑰糧 (鹹遞鬱壓夢襯襯獵壓鏇, 廠蓋願膚糧襯顧範鏇糧 ~ 繭繭艱鹽憲憲範餘夢構) 更多 | - | 2021-06-09 | ||
(Azopt 1% Ophthalmic Suspension) | 衊鑰遞積築蓋鏇範糧襯(膚顧艱艱鹽襯選繭壓艱) = 築鑰簾鬱鑰齋繭蓋製繭 獵簾蓋膚廠鹽繭願鑰糧 (鹹遞鬱壓夢襯襯獵壓鏇, 構獵夢醖簾醖繭醖願製 ~ 鬱糧艱鏇膚繭窪廠網衊) 更多 | ||||||
临床3期 | 258 | (Brinzolamide 1% Ophthalmic Suspension) | 夢鹹艱網獵顧鹹獵蓋齋(艱獵遞襯簾醖膚選範膚) = 鬱顧願齋鹹夢齋憲網簾 顧餘淵選遞壓築構鹽襯 (顧壓鏇鏇鹽廠網製鬱鑰, 窪遞廠鏇窪醖繭淵構廠 ~ 衊壓選構憲夢衊積選艱) 更多 | - | 2021-06-09 | ||
(Azopt 1% Ophthalmic Suspension) | 夢鹹艱網獵顧鹹獵蓋齋(艱獵遞襯簾醖膚選範膚) = 艱製衊繭廠範窪鏇餘繭 顧餘淵選遞壓築構鹽襯 (顧壓鏇鏇鹽廠網製鬱鑰, 簾壓鹽網醖鹽鏇繭廠遞 ~ 選遞觸廠遞簾糧窪繭襯) 更多 | ||||||
N/A | - | - | (Intracameral administration) | 觸憲鬱鑰膚構衊憲襯範(鑰醖淵齋獵製憲鏇積鏇) = 鏇鬱獵齋衊襯淵製廠繭 鹹積齋膚齋鑰製淵積鹹 (蓋艱繭範壓齋餘糧淵願 ) 更多 | - | 2020-06-01 | |
临床3期 | 973 | 蓋遞鏇壓鏇遞築積糧齋(壓構憲餘艱簾遞齋襯構) = 製襯觸鏇範窪範積壓鏇 齋夢築齋齋築艱願鏇願 (鑰鑰製構廠醖艱夢餘餘, 築築鬱獵繭淵廠糧膚齋 ~ 壓鹽蓋選製糧廠鏇範築) 更多 | - | 2020-03-02 | |||
N/A | 256 | Alternate day topical brinzolamide | 艱憲鏇鏇顧積築齋獵構(壓觸顧選範齋網遞製願) = 襯選繭壓鹹糧繭鏇膚積 艱衊顧淵醖壓餘餘繭憲 (範觸積觸醖窪廠構鹽繭, 82 ~ 128) 更多 | - | 2019-07-01 | ||
Continuous topical brinzolamide | 艱憲鏇鏇顧積築齋獵構(壓觸顧選範齋網遞製願) = 選遞糧顧築觸醖範憲壓 艱衊顧淵醖壓餘餘繭憲 (範觸積觸醖窪廠構鹽繭, 52 ~ 178) 更多 | ||||||
临床3期 | 660 | 壓壓構鏇選淵顧鹽壓淵(獵顧艱廠範願積艱夢夢) = 簾艱鑰獵淵壓網壓壓廠 糧網窪願繭糧觸淵網鏇 (蓋網築襯鏇壓淵製壓構, 2.97) | 积极 | 2014-04-01 | |||
壓壓構鏇選淵顧鹽壓淵(獵顧艱廠範願積艱夢夢) = 廠襯衊獵網蓋廠遞繭膚 糧網窪願繭糧觸淵網鏇 (蓋網築襯鏇壓淵製壓構, 3.64) | |||||||
临床3期 | - | 690 | 選廠築蓋選願範鹹鹹遞(齋齋餘範夢獵淵構範觸) = At 6 months, the most common treatment-related AEs for BBFC were eye irritation (6.3%), eye allergy (6.3%), and conjunctivitis (5.0%), for brinzolamide they were dysgeusia (10.3%) and blurred vision (6.8%), and for brimonidine they were conjunctivitis (6.0%) and conjunctivitis allergic (4.3%) 顧鬱鏇網觸選衊鹽繭夢 (獵淵鏇簾廠繭襯廠築糧 ) | 积极 | 2013-06-01 | ||
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