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What Is In Vitro Release Testing - IVRT | Tergus Pharma

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Mark William
What Is In Vitro Release Testing  - IVRT | Tergus Pharma

The drug development fundamental is something that involves the analysis of the release of drugs from the dosage form. It requires a specific technique for determining the complete dosage form itself and also the route of delivery. Dissolution testing has been in practice for at least 50 years for those of solid dosage forms.

In recent times, IVRT (in vitro release testing) witnessed its growing popularity for those of semisolid dugs. It has become the most useful technique for determining release characteristics. An IVRT rate tends to show a fully combined effect of various chemical and physical parameters, which include both the size of particle and solubility of API of the dosage form.

If we talk about the application of the IVRT method, it is generally used in an open chamber design, which is similar to the Franz diffusion cell system. Besides, it is perfect to be used with a synthetic membrane, biological sample, or tissue construct.

The core purpose of IVRT is the function as a surrogate for in vivo testing. Therefore, the medium that has a good resemblance with the physiological fluid is indeed highly preferred. And this is the actual reason why PBS is considered to be the top-most choice. Meanwhile, APIs accompanied with low aqueous solubility generally necessitate the complete modification of PBS for increasing the solvency for approaching the sink conditions.

Sometimes, IVRT medium also works appropriately for two selections as well. First, it can be applied for QC with the main purpose of change control in the manufacturing process and tests for long-term stability. Second, it is also considered to be appropriate for imitating in vivo behavior with the use of physiologically relevant media. This medium indeed works effectively for producing a potential correlation between in vitro and in vivo. The data that comes as the output of IVRT serves as a summary of releasing rates over a short period.

 

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