Delving into the Latest Updates on Domperidone Maleate with Synapse

考察健康受试者空腹及餐后单次口服受试制剂马来酸多潘立酮片（规格：每片含马来酸多潘立酮12.72 mg，相当于多潘立酮10mg）的人体药代动力学特征，并以已上市的马来酸多潘立酮片（商品名：MOTILIUM®；规格：10 mg/片，按多潘立酮计）为参比制剂，两周期两交叉设计进行人体生物等效性研究，并观察受试制剂和参比制剂在健康受试者中的安全性

[Translation]

The pharmacokinetic characteristics of the test preparation domperidone maleate tablets (specification: each tablet contains 12.72 mg domperidone maleate, equivalent to 10 mg domperidone) were investigated in healthy subjects after single oral administration on an empty stomach or after meals. The marketed domperidone maleate tablets (trade name: MOTILIUM®; specification: 10 mg/tablet, calculated as domperidone) were used as the reference preparation. A two-period, two-crossover design was used to conduct a human bioequivalence study, and the safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date30 Jul 2019

Sponsor / Collaborator

Beijing Hanmi Pharmaceutical Co., Ltd.

NCT01512225 / CompletedPhase 2IIT

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

The purpose of this study is to evaluate the safety and efficacy of Domperidone in those mothers who are identified as having difficulty with breast milk production to meet the nutritional needs of their infant in the neonatal intensive are unit hospitalization setting, and to determine how it should be considered in the care of mothers and their preterm infants without causing undesirable effects to either the mother or infant.

Start Date01 May 2012

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

100 Clinical Results associated with Domperidone Maleate

Login to view more data

100 Translational Medicine associated with Domperidone Maleate

Login to view more data

100 Patents (Medical) associated with Domperidone Maleate

Login to view more data

10

Literatures (Medical) associated with Domperidone Maleate

01 Aug 2024·Current 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

Author: Özcan, Saniye ; Diril, Mine ; Kaynak, Mustafa Sinan ; Çağlar, Emre Şefik ; Karasulu, Hatice Yeşim ; Okur, Neslihan Üstündağ

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.

01 Mar 2016·Saudi Pharmaceutical JournalQ3 · MEDICINE

Formulation development and evaluation of medicated chewing gum of anti-emetic drug

Q3 · MEDICINE

ArticleOA

Author: Patel, Bhautik ; Gajra, Balaram ; Paradkar, Mansi

CONTEXTMedicated 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.OBJECTIVEFormulation development of MCG of DM and optimization of the formulation by screening of different excipients.MATERIAL AND METHODSMCG 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 DISCUSSIONThe 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.CONCLUSIONThe 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.

01 Aug 2007·Acta Pharmacologica SinicaQ1 · MEDICINE

Influence of omeprazole on pharmacokinetics of domperidone given as free base and maleate salt in healthy Chinese patients

Q1 · MEDICINE

Article

Author: Hua-ling Yu ; Qi-zhi Liu ; Xiao-yan Chen ; Yi-fan Zhang ; Da-fang Zhong ; Yi-ni Zhang ; Xiao-jian Dai

AIMTo investigate the influence of omeprazole on the pharmacokinetics of domperidone given as free base and maleate salt.METHODSAn 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.RESULTSFor 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).CONCLUSIONPretreatment of omeprazole does not affect the absorption of domperidone maleate, but leads to a moderately decreased rate of absorption of the free base.

100 Deals associated with Domperidone Maleate

Login to view more data