更新于：2024-06-20
Dapoxetine Hydrochloride
盐酸达泊西汀
更新于：2024-06-20
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 芬兰 (2009-02-01), |
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C21H24ClNO |
InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N |
CAS号129938-20-1 |
关联
82
项与 盐酸达泊西汀 相关的临床试验盐酸达泊西汀片单中心、随机、开放、两制剂、两序列、两周期交叉单次给药健康成年男性生物等效性试验
盐酸达泊西汀片在健康男性受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验
盐酸达泊西汀片人体生物等效性预试验
100 项与 盐酸达泊西汀 相关的临床结果
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100 项与 盐酸达泊西汀 相关的转化医学
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100 项与 盐酸达泊西汀 相关的专利（医药）
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90
项与 盐酸达泊西汀 相关的文献（医药）2024-05-01Journal of clinical pharmacology
Effects of CYP2D6 *10 and *41 Variants in Healthy Chinese Men on the Pharmacokinetics of Dapoxetine
Article
作者: Wu, Tong ; Ji, Xingfang ; Gao, Yuan ; Qiu, Wen ; Wang, Zhipeng ; Pu, Libin
Abstract:
Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat premature ejaculation (PE), and is mainly metabolized by CYP2D6, CYP3A4, and flavin‐containing monooxygenase 1. The purpose of the study was to evaluate the effect of CYP2D6 polymorphism on the pharmacokinetics of dapoxetine in healthy Chinese men. Thirty‐nine subjects who received a single oral dose of 30 mg dapoxetine hydrochloride were classified based on their CYP2D6 genotype: *1/*1 (n = 9), *1/*41 (n = 1), *1/*10 (n = 12), *10/*41 (n = 3), or *10/*10 (n = 14). The difference in pharmacokinetic parameters between different genotype groups was analyzed and then scored according to the activity score system. Compared with the wild‐type subjects of CYP2D6 *1/*1, the peak plasma concentration (Cmax) and the area under the plasma drug concentration‐time curve (AUCinf) of dapoxetine in the *10/*10 and *10/*41 groups were notably increased (P ≤ .05). Significant differences in Cmax, AUC, volume of distribution/bioavailability (V/F) and clearance/bioavailability (CL/F) were observed among dapoxetine activity score groups (P ≤ .05). The AUCinf was increased significantly (154% and 89.73%, P ≤ .05) and the Cmax was increased significantly (73.45% and 42.67%, P ≤ .05) in CYP2D6 *10/*41 subjects, compared with CYP2D6 *1/*1 and *1/*10 subjects. The results obtained indicated that CYP2D6 *10 and *41 polymorphisms have significant effects on the pharmacokinetic properties of dapoxetine.
2023-11-02Journal of AOAC International
Eco-Friendly UV-Spectrophotometric Methods Employing Magnetic Nano-Composite Polymer for the Extraction and Analysis of Sexual Boosters in Adulterated Food Products: Application of Computer-Aided Design
Article
作者: Eissa, Maya S ; Attala, Khaled ; Abdel Salam, Randa A ; Elsonbaty, Ahmed ; Abdelshakour, Mohamed A ; Mostafa, Aziza E ; Hadad, Ghada M
Abstract:
Background:
Solid phase extraction (SPE) techniques, based on computationally designed magnetic-based multi-targeting molecular imprinted polymer (MT-MIP), combined with UV spectrophotometric approaches provide advantages in the examination of counterfeit samples.
Objective:
The current work describes an innovative and sustainable methodology for the simultaneous determination of tadalafil (TAD) and dapoxetine hydrochloride (DAP) in aphrodisiac counterfeit products (honey and instant coffee) utilizing SPE exploiting MT-MIP. Additionally, an innovative UV spectrophotometric method capable of resolving TAD in its pharmaceutical binary mixtures with DAP was developed. A novel computational approach was implemented to tailor the synthesis and design of the MT-MIP particles.
Methods:
We applied a newly developed UV spectrophotometric method which was based on a Fourier self-deconvolution (FSD) method coupled with the isoabsorptive point for determination of TAD and DAP in pharmaceutical dosage form. We also applied an SPE process based on MT-MIP designed particles, assisting in the analysis of both drugs in counterfeit food samples. The SPE process and the UV spectroscopic methodology were assessed regarding their greenness using the pioneering green analytical procedure index (GAPI), analytical greeness including sample preparation (AGREEprep) and AGREE tools. The synthesized MT-MIP particles were characterized by scanning electron microscopy and energy-dispersive x-ray spectroscopy.
Results:
The suggested spectrophotometric methods revealed a wide linear concentration range of 2–50 µg/mL with lower LODs in the range of 0.604–0.994 µg/mL. Additionally, the suggested method demonstrated the utmost sensitivity and eco-friendliness for their target in its mixed dosage form and counterfeit food products.
Conclusion:
The SPE process and the developed analytical UV spectroscopic methodology were validated as per the ICH guidelines, and were found to be suitable for overseeing some counterfeiting activities in commercially available honey and instant coffee aphrodisiac products.
Highlights:
An SPE method based on MT-MIP magnetic-based polymer and a UV spectroscopic method were successfully developed for analysis of TAD and DAP in different matrices.
2023-10-01Heliyon
Innovative and sustainable deconvoluted amplitude factor spectrophotometric method for the resolution of various severely overlapping pharmaceutical mixtures: Applying the complex-GAPI-tool
Article
作者: E Mostafa, Aziza ; Attala, Khaled ; Abdelshakour, Mohamed A ; Elsonbaty, Ahmed ; M Hadad, Ghada ; Eissa, Maya S ; A Abdel Salam, Randa
UV spectroscopy is considered the simplest, the most money and time investor technique in analytical research. Besides its lowered solvent and energy consumption leading to greener outcomes, its practicality is wide and suitable for a wide range of applications. Multicomponent mixtures are always representing themselves as a problematic challenge for any analytical technique fortunately UV spectroscopic methods found many ways to tackle these mixtures. Fourier self-deconvolution (FSD) was recently applied in UV spectroscopy as an effective tool for the resolution of binary mixtures unfortunately like any other method may fail to completely resolve severely overlapping mixtures. In this paper, we epitomize the newly developed deconvoluted amplitude factor (DAF) spectrophotometric approach which couples the concepts of both the FSD and the amplitude factor methods for the resolution of tadalafil (TAD) in its binary mixtures with dapoxetine hydrochloride (DAP) or tamsulosin hydrochloride (TAM). The embraced approach was assessed regarding its greenness utilizing different assessing protocols to give evident proof for its sustainability. The innovative approach showed an enhancement in the resolution of binary mixtures and showed high sensitivity as noticed from limits of detection and quantitation which were (0.374, 1.136 μg/mL), (0.269, 0.817 μg/mL), and (0.518, 1.569 μg/mL) for TAD, DAP, and TAM, respectively. The method was validated as per ICH guidelines recommendations and also was statistically compared with recently reported methods which revealed no statistically significant difference. A very handy and reader-friendly data presentation approach was followed for the ease of statistical data interpretation and evaluation.
100 项与 盐酸达泊西汀 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 早泄 | 芬兰 | 2009-02-01 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 勃起功能障碍 | 临床3期 | - | 2004-12-01 | |
| 生理性性功能障碍 | 临床3期 | - | 2004-11-01 |
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临床3期 | 495 | Placebo (PDE5I + Placebo (Baseline)) | 艱鹽鹽願鏇衊鹽選膚憲(衊網顧觸齋餘製顧壓網) = 繭網鏇觸憲鏇餘獵簾遞 顧製積淵顧鑰壓艱淵選 (願夢膚築廠構網築齋築, 艱襯遞築觸蓋範壓顧網 ~ 範餘獵簾遞鹽餘鬱夢壓) | - | 2012-11-04 | ||
Placebo (PDE5I + Placebo (Week 12)) | 艱鹽鹽願鏇衊鹽選膚憲(衊網顧觸齋餘製顧壓網) = 醖網繭鑰顧範獵壓製築 顧製積淵顧鑰壓艱淵選 (願夢膚築廠構網築齋築, 膚糧鏇積壓簾壓衊廠鬱 ~ 網膚遞選鏇淵鹹淵鏇網) |
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