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Pharmaceutical Industry | Chemical Analytics | Automatisation of Tablet Dissolution Tests

Automated Dissolution Testing Using Spectroscopic Online Analysis

The optimal therapeutic efficacy of solid pharmaceutical depends on more than just the right amount of the active ingredient

Drugs provide targeted solutions for the health of humans and animals. For optimal efficacy, it is not only important that the appropriate active ingredient is taken in the right quantity, but also where and over what period of time the tablet or capsule taken releases its active ingredients.

For pharmaceuticals in solid or semi-solid dosage form, drug release is an essential precondition for drug absorption, bioavailability and ultimately the therapeutic efficacy of a drug. To ensure consistent release and optimal product standards, dissolution tests are used to determine the rate and extent of dissolution and to establish release profiles. This method is therefore of great importance in pharmaceutical development, the validation of manufacturing processes and the market release of drugs.

Challenge

Compliant and at the same time cost-efficient performance of dissolution tests

 

 

Area of Application

  • Active ingredient analysis
  • Active ingredient release

 

 

Scope of Application

Dissolution tests for active ingredients in solid dosage forms

Method

  • Optical Spectroscopy

  • Online Analysis

  • Robotics

Solution

  • NIR Spectroscopy

  • Online Measurement

Benefits

  • Precise Process Control
  • High Process Security
  • Increase in Efficiency
  • Process Optimisation

The Challenge

Manual dissolution testing is work-intensive and prone to errors

Dissolution tests must be performed according to a standardized procedure as described in the pharmacopoeias of the three major regional Pharmacopeia organizations EP/USP/JP. Samples must be filtered prior to analysis and subsequently measured photometrically. The results of the tests must be reliable, reproducible, and accurately documented. An ever-increasing number of samples due to new drug forms makes it more and more difficult for manufacturing companies to produce in a compliant and cost-efficient manner. Non-automated solutions are also error-prone due to the human factor.

The Application

stirrer device for tablet dissolution tests with optical immersion probe

To establish a release profile according to EP/USP/JP, complex analyses have to be carried out on six tablets at multiple testing intervals. Due to the high precision and reliability of this method, the use of optical spectroscopy has become established for this application.

When analyzing tablet dissolution tests using optical spectroscopy, the dissolution rate of the tablet is determined by measuring the absorption of the active ingredients in a precise path length.

 

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Contact/Inquiry

Hellma USA Inc.
80 Skyline Drive
11803 Plainview, NY
United States

Phone: +1 5169 3908 88
info.us@hellma.com
http://www.hellmausa.com

Contact/Inquiry

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Complete Application Note

Automated Dissolution Testing Using Spectroscopic Online Analysis

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