5. Fourth development phase: formulation and process testing

5.1 Formulation tests

Formulation tests follow on from the tests carried out during the pre-formulation phase, and enable the identification of material attributes with a high risk of impacting on the CQAs of the finished product. A qualitative and quantitative evaluation of the formulas using the experimental design method enables the most suitable formulation to be chosen. The proportion of CMC can influence the finished product's AQA (uniformity of content, dosage and dissolution), since it can affect both the quality of compaction and the breaking strength of tablets during the compression phase.

The selection of the final formulation should take into account the elements summarized below:

• the difference between...