Pharmaceutical Industry | Chemical Analytics | Automatisation of Tablet Dissolution Tests
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.
Compliant and at the same time cost-efficient performance of dissolution tests
Dissolution tests for active ingredients in solid dosage forms
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.
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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