CONSULTANCY FOR YOUR DISSOLUTION TESTING REQUIREMENTS
Dissolution is a routine test used to evaluate the drug release properties of pharmaceutical products.
The development of dissolution methods requires careful consideration in order to elucidate the most useful information for a particular purpose. For example if in-vitro in-vivo correlations (IVIVC) are required, bio-relevant dissolution media must be employed, typically aqueous solutions of a surfactant such sodium taurocholate, sodium dodecyl sulfate or polysorbate in a 50 mM phosphate buffer at pH 6.8.
However, if the method is to be used in a quality control environment to detect out of specification batches, it is necessary for the method to be discriminating. In developing such a method it is necessary to carefully consider the chemical and solubility properties of the drug substance and develop a method that will show formulation dependent profiles.
We can offer scientific and technical consultancy, assistance and advice throughout the method development process in order to obtain the best optimised method for your requirements.
In addition, We can offer scientific and technical consultancy to resolve problems and issues with dissolution methods