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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.

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

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經(jīng)常在白天和夜間需要口服/肛門藥物或營養(yǎng)制劑的穩(wěn)定供應。而不必在白天和夜間采取片劑或膠囊在頻繁的時候，控釋片/膠囊已經(jīng)發(fā)展到提供準備多個小時的釋放率固定，而無需不斷地咽下藥片主題/主題的膠囊。




控釋片劑/膠囊中需要進行測試，以確保它們實際上釋放出藥物或營養(yǎng)食品，在所要求的速率。溶出試驗是一個既定的檢驗釋放的速率的手段。




多數(shù)在溶解字段用于系統(tǒng)采用紫外/可見分光光度計作為分析的所選形式。這樣的系統(tǒng)是相對容易的設(shè)置和運行。此試樣分析可以在手動或自動的基礎(chǔ)上進行的。




樣品濃度的結(jié)果可以由計算機軟件和圖解活性分析物濃度隨時間變化（溶出曲線）自動記錄可以生成。




在本實例中進行了UV /可見光分光光度法測定，不能使用，這可能是因為被分析物不具有紫外/可見發(fā)色團，還有賦形劑基質(zhì)和/或分析物的干擾，或在需要多于一種活性藥物/營養(yǎng)藥物成分被測試在相同的溶出度來看， HPLC /集成電路的分析和檢測，可以使用。檢測活性藥物/營養(yǎng)藥物成分可以是它們的許多性能，如紫外/可見吸光度，電導率，折射率和熒光的基礎(chǔ)上。此HPLC /集成電路分析可以手動或自動和上線的基礎(chǔ)上進行的。




我們所有的溶出系統(tǒng)是節(jié)省空間和實用性。我們提供全面的軟件套件和所有您和您的監(jiān)管機構(gòu)/部門可能要求的配件。

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