更新于：2024-11-18
Domperidone Maleate
马来酸多潘立酮
更新于：2024-11-18
概要
基本信息
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C26H28ClN5O6 |
InChIKeyOAUUYDZHCOULIO-BTJKTKAUSA-N |
CAS号99497-03-7 |
关联
2
项与 马来酸多潘立酮 相关的临床试验马来酸多潘立酮片随机、开放、两周期、两交叉单次空腹及餐后生物等效性试验
Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
100 项与 马来酸多潘立酮 相关的临床结果
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100 项与 马来酸多潘立酮 相关的转化医学
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100 项与 马来酸多潘立酮 相关的专利（医药）
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10
项与 马来酸多潘立酮 相关的文献（医药）2024-08-01Current drug delivery
Enhancing Oral Bioavailability of Domperidone Maleate: Formulation,
In vitro Permeability Evaluation In-caco-2 Cell Monolayers and In situ Rat
Intestinal Permeability Studies
Article
作者: Diril, Mine ; Karasulu, Hatice Yeşim ; Özcan, Saniye ; Kaynak, Mustafa Sinan ; Okur, Neslihan Üstündağ ; Çağlar, Emre Şefik
Background::
The domperidone maleate, a lipophilic agent classified as a Biopharmaceutical
Classification System Class II substance with weak water solubility. Self- Emulsifying Drug Delivery
System is a novel approach to improve water solubility and, ultimately bioavailability of drugs.
Objective::
This study aimed to develop and characterize new domperidone-loaded self-emulsifying drug
delivery systems as an alternative formulation and to evaluate the permeability of domperidone-loaded
self-emulsifying drug delivery systems by using Caco-2 cells and via single-pass intestinal perfusion
method.
Methods::
Three self-emulsifying drug delivery systems were prepared and characterized in terms of pH,
viscosity, droplet size, zeta potential, polydispersity index, conductivity, etc. Each formulation underwent
10, 100, 200, and 500 times dilution in intestinal buffer pH 6.8 and stomach buffer pH 1.2, respectively.
Female Sprague Dawley rats were employed for in situ single-pass intestinal perfusion investigations.
Results::
Results of the study revealed that the ideal self-emulsifying drug delivery systems formulation
showed narrow droplet size, ideal zeta potential, and no conductivity. Additionally, as compared to the
control groups, the optimum formulation had better apparent permeability (12.74 ± 0.02×10-4) from
Caco-2 cell monolayer permeability experiments. The study also revealed greater Peff values (2.122 ±
0.892×10-4 cm/s) for the optimal formulation from in situ intestinal perfusion analyses in comparison to
control groups (Domperidone; 0.802 ± 0.418×10-4 cm/s).
Conclusion::
To conclude, prepared formulations can be a promising way of oral administration of Biopharmaceutical
Classification System Class II drugs.
2016-03-01Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society3区 · 医学
Formulation development and evaluation of medicated chewing gum of anti-emetic drug
3区 · 医学
ArticleOA
作者: Paradkar, Mansi ; Gajra, Balaram ; Patel, Bhautik
CONTEXT:
Medicated chewing gum (MCG) of Domperidone Maleate (DM) was developed by direct compression method with the goal to achieve quick onset of action and to improve patient compliance.
OBJECTIVE:
Formulation development of MCG of DM and optimization of the formulation by screening of different excipients.
MATERIAL AND METHODS:
MCG containing DM was prepared by screening different concentrations of sweeteners, flavouring agents, softening agents, lubricants and anti-adherents by changing one variable at a time. Performance evaluation was carried out by evaluating size, shape, thickness, taste, scanning electron microscopy, texture analysis, in vivo drug release study, ex vivo buccal permeation study and by studying statistical analysis for quality.
RESULTS AND DISCUSSION:
The statistical analysis showed significant improvement in organoleptic properties such as chewable mass, product taste, product consistency, product softness, total flavour lasting time and pharmaceutical properties like micromeritic properties after incorporation of appropriate excipients in an optimum amount in final optimized MCG formulation. In vivo drug release study showed 97% DM release whereas ex vivo buccal permeation study through goat buccal mucosa exhibited 11.27% DM permeation within 15 min indicating its potential for increasing bioavailability by decreasing time of onset. The optimized formulation showed good surface properties and the peak load required for drug release was found to be acceptable for crumbling action.
CONCLUSION:
The developed formulation of medicated chewing gum can be a better alternative to mouth dissolving and conventional tablet formulation. It may be proved as a promising approach to improve the bioavailability as well as to improve patient compliance.
2007-08-01Acta pharmacologica Sinica1区 · 医学
Influence of omeprazole on pharmacokinetics of domperidone given as free base and maleate salt in healthy Chinese patients
1区 · 医学
Article
作者: Qi-zhi Liu ; Hua-ling Yu ; Xiao-yan Chen ; Yi-fan Zhang ; Xiao-jian Dai ; Yi-ni Zhang ; Da-fang Zhong
AIM:
To investigate the influence of omeprazole on the pharmacokinetics of domperidone given as free base and maleate salt.
METHODS:
An open, randomized, 2-period crossover study with a washout period of 7 d was conducted in 10 healthy Chinese, male patients. In each study period, the patients were administered a single oral dose of 10 mg domperidone as free base or maleate salt on d 1, 20 mg omeprazole twice daily on d 2 and 3, and once on d 4. A single dose of 10 mg domperidone as free base or maleate salt was taken at 4 h after administration of omeprazole on d 4. Plasma samples were collected on d 1 and 4 after the administration of domperidone, and the plasma concentrations of domperidone were determined by a sensitive liquid chromatography-tandem mass spectrometry method.
RESULTS:
For free-base domperidone, pretreatment with omeprazole resulted in a 16% decrease in maximum concentration (C(max)), compared with administration alone (P<0.05). However, for maleate salt, with the exception of an increase in t(1/2), no pharmacokinetic parameters were significantly changed. When the free base and maleate salt were administered alone, no differences were found in any parameters between the 2 formulations. In contrast, when they were administered in the presence of omeprazole, the C(max) of domperidone given as free base was lower (25.9%) than that given as maleate salt (P<0.05).
CONCLUSION:
Pretreatment of omeprazole does not affect the absorption of domperidone maleate, but leads to a moderately decreased rate of absorption of the free base.
100 项与 马来酸多潘立酮 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 消化不良 | 中国 | 2005-01-24 | |
| 恶心 | 中国 | 2005-01-24 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 乳腺癌 | 临床1期 | 中国 | 2019-11-13 | |
| 非小细胞肺癌 | 临床1期 | 中国 | 2018-06-05 |
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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2期 | 90 | Domperidone (Group A: Domperidone) | 繭繭網窪繭糧範範糧鹽(廠膚網範壓繭製窪鹹衊) = 蓋鹹鹽廠壓壓構遞範糧 糧遞醖餘壓鏇齋衊鏇鏇 (鹽鑰窪膚餘範鹹淵餘鑰, 鏇醖選積糧鏇製壓窪觸 ~ 窪憲鑰衊壓襯觸糧艱齋) 更多 | - | 2017-04-20 | ||
Placebo+Domperidone (Group B: Placebo + Domperidone) | 繭繭網窪繭糧範範糧鹽(廠膚網範壓繭製窪鹹衊) = 醖衊構鏇鹽餘憲夢積餘 糧遞醖餘壓鏇齋衊鏇鏇 (鹽鑰窪膚餘範鹹淵餘鑰, 願憲顧壓築網醖壓構衊 ~ 齋鹹廠顧網選夢齋糧願) 更多 |
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