1) Identification of the physico-chemical characteristics of the active ingredients (with relevant certificate of analysis), such as: solubility, particle size, analytical control method, sources of supply, etc.
2) Joint study with the interested company, to determine the characteristics of the finished product, among which:
- identification of the final form (capsules, tablets, single dose small bottles or sachets, etc.) to be developed,
- quantity of active ingredients per single dose,
- length of the in vitro release of the active ingredients, in relation to their half-life, which might call for repeated administrations, and other characteristics,
- size of the trial and pilot batches (see below)
3) Tests of coating of the active ingredients.
4) Production of a trial batch having the desired in vitro controlled release pattern.
5) Production of a pilot batch corresponding to the characteristics described at point 2, accompanied by all the relevant technical specifications, including:
- method for the determination of the in-vitro release pattern,
- quali-quantitative composition,
- production method.