The formulation of each medicine – just like the molecule assigned to each medicine – is unique. Meditop initiates each of its medicine development projects with a comprehensive development plan.
The strategy for developing medicines is based on the thorough analysis of preformulatory data. In certain cases, development poses significant challenges, for example, if the active ingredient's bioavailabillity is low, its water-solubility and/or permeability is poor, or its physiological stability is poor. The development of the pharmaceutical form during the process helps to overcome these problems.
Meditop's development process of pharmaceutical forms is a logical process built on analysis of the data. Its main phases are:
- Preformulatory solubility and stability tests
- Thorough and wide-ranging excipient compatibility test
- Bench-scale production
- Optimisation and finalisation of the pharmaceutical form
- Pilot production
- Stability testing
- Validation, including that of the production process and analytical method
- Preparation of documentation