Often a constant supply of an oral/anal pharmaceutical or nutraceutical preparation is required during the day and night. Instead of the subject having to take tablets or capsules at frequent times during the day and night, controlled release tablets/capsules have been developed to provide a constant rate of release of the preparation for many hours, without the subject having to continually ingest tablets/capsules.
Controlled release tablets/capsules need to be tested to ensure that they do actually release the drug or nutraceutical, at the required rate. Dissolution testing is an established means of testing the rate of release.
The majority of systems used in the dissolution field employ UV/Visible spectrophotometry as the chosen form of analysis. Such systems are relatively easy to set up and run. This sample analysis can be performed on a manual or automatic basis.
Sample concentration results can be automatically recorded by computer software and plots of active analyte concentrations over time (dissolution profile) can be generated.
In the instances were UV/Visible spectrophotometry cannot be used, perhaps because the analyte does not have a UV/Visible chromophore, there is excipient matrix and/or analyte interference, or where more than one active pharmaceutical/nutraceutical ingredient is required to be tested in the same dissolution run, HPLC/IC analysis and detection may be used. Detection of the active pharmaceutical/nutraceutical ingredients may be on the basis of many of their properties, such as UV/Visible Absorbance, conductivity, refractive index and fluorescence. This HPLC/IC analysis can be performed manually or on an automatic and on-line basis.
All of our dissolution systems are space saving and practical. We offer comprehensive software packages and all of the accessories you and your regulatory authority/authorities may require.
CE 3790 Dissolution Tester Cecil Instruments offer complete dissolution systems as well as all the components of the system individually. The dissolution tester is common to the systems and may be used in conjunction with a choice of spectrophotometers and HPLC/IC systems. It is fully USP, EP and JP compliant.
The CE 3790 tester is provided with seven stirred round bottom, graduated, glass vessels; the eighth position is used for stirring the thermostatted water in the perspex bath.
The water is heated by a 1000 watt element and the temperature may be set between 30°C and 45°C with an accuracy of ±0.2°C.
CE 3792 Software - WIN DISS
This is a comprehensive dissolution software package for control and data processing, incorporating the following features:
Storage for 100 methods; stores stirrer speed, temperature, sampling sequence, measuring wavelength etc.
A time run data store for batch number, name, operator ID, calculation details, data correction using run or pre-run blank, media evaporation etc. Calculation details include theoretical maximum Absorbance, measured standard concentration, standard measurements using linear regression and standard concentration at known testing times.
Results are printed in tabular and graphical form including Absorbance data, milligrams or % release and a 95% confidence calculation is provided. The printout may be formatted by the operator
=============================================
经常在白天和夜间需要口服/肛门药物或营养制剂的稳定供应。而不必在白天和夜间采取片剂或胶囊在频繁的时候,控释片/胶囊已经发展到提供准备多个小时的释放率固定,而无需不断地咽下药片主题/主题的胶囊。
控释片剂/胶囊中需要进行测试,以确保它们实际上释放出药物或营养食品,在所要求的速率。溶出试验是一个既定的检验释放的速率的手段。
多数在溶解字段用于系统采用紫外/可见分光光度计作为分析的所选形式。这样的系统是相对容易的设置和运行。此试样分析可以在手动或自动的基础上进行的。
样品浓度的结果可以由计算机软件和图解活性分析物浓度随时间变化(溶出曲线)自动记录可以生成。
在本实例中进行了UV /可见光分光光度法测定,不能使用,这可能是因为被分析物不具有紫外/可见发色团,还有赋形剂基质和/或分析物的干扰,或在需要多于一种活性药物/营养药物成分被测试在相同的溶出度来看, HPLC /集成电路的分析和检测,可以使用。检测活性药物/营养药物成分可以是它们的许多性能,如紫外/可见吸光度,电导率,折射率和荧光的基础上。此HPLC /集成电路分析可以手动或自动和上线的基础上进行的。
我们所有的溶出系统是节省空间和实用性。我们提供全面的软件套件和所有您和您的监管机构/部门可能要求的配件。
技术规格:
|