溶出成败的关键

专为难溶和缓释药物制剂型设计的符合流池法的第四代设备,符合USP、EP和JP药典要求,特别适合于溶媒用量少和漏槽条件下难溶化合物的溶出度测定,在仿制药一致性评价,以及生物等效性实验要求方法提供选择。

新药研发

仿制药一致性评价

生物等效性实验

流池法

pH切换

多种流通池

专为不同实验而设计

MR(调节释放)

ER(缓释)

CR(控释)

体积无限制
15ml→∞(选配)

流池法适用于各种剂型

混悬剂
微球,纳米微球
脂质体
药物涂层支架
霜剂及软膏
凝胶剂
片剂
粉末
栓剂
埋植剂
软胶囊
微丸
API
医疗器械
眼用制剂

混悬剂

微球,纳米微球

脂质体

药物涂层支架

霜剂及软膏

凝胶剂

片剂

粉末

栓剂

埋植剂

软胶囊

微丸

API

医疗器械

眼用制剂

SOTAX CE 7smart可以开环或闭环的配置操作,可连接紫外可见光谱仪,通过WinSOTAX高级溶出软件在整个溶出度测定过程进行在线控制。离线分析时,CE 7smart可连接至馏分收集器。当CE 7smart与紫外和馏分收集器同时连接时,可获得最大的灵活性。

软件控制符合21 CFR要求

  • 基于流通池设计概念,更接近体内溶出条件
  • 前面板图形显示,一次显示所有操作参数
  • 在线溶媒和pH切换(适用于特定配置)
  • 自动样品制备和清洗
  • 集成清洁功能
  • 软件控制符合21 CFR要求
  • 制药工业

相关产品

联系

400-6337-656

销售

nikyang_hk

Flow through cell Dissolution Tester

Dissolution tester for poorly soluble and release control dose forms

The CE 7smart is the 4th generation of Sotax's design for dissolution of poorly soluble and release control dosage forms via USP Apparatus 4 (Flow-Through Cell Dissolution), and is compliant to USP, EP and JP for Small Volume Dissolution and Poorly Soluble Compound Testing under Sink conditions. Based on 35 years of experience, the CE 7smart meets USP requirements for the flow rate and temperature to be qualified, and is designed to overcome potential challenges linked to method development for a variety of dosage forms.

Able to operate in an open or closed loop configuration, the CE 7smart can be coupled with a UV-visible spectrophotometer under the control of WinSOTAX Advanced Dissolution Software for on-line measurements throughout the dissolution. For off-line analysis, the CE 7smart can be connected to a fraction collector. When maximum flexibility is needed the CE 7smart can be connected to both a UV and a fraction collector.

  • Can handle a wide range of test substances with cells designed for MR (Modified Release), CR (Controlled Release) and ER (Extended Release) dosage forms in different formats
  • Cells designed for variable dosage forms: tablets, powders, implants, suppositories, soft gelatin capsules, pellets, APIs, medical devices, ophthalmic devices, drug-eluting stents, creams and ointments, gels, suspensions, microspheres, liposomes and nanospheres
  • No limitation on the volume: 15ml→∞ (option)
  • Easily configured on- or offline to meet different requirements – can set different flow rate to speed up method development
  • Based on flow-through cell design concept, closer to in vivo dissolution
  • Front keypad with graphic display shows all operating parameters at a glance.
  • Online changing of media (for specified configuration)
  • Automated sample preparation and rinsing
  • Integrated cleaning functions
  • 21 CFR compliant for software control
  • Pharmaceutical industry