For the future of MEDITOP Pharmaceuticals Ltd., research and development is of paramount importance and essential to ensure its development. The company has now achieved a competitive position in R&D compared to other local pharmaceutical companies.
The success of our R&D is demonstrated by the fact that we have 15 inventions and corresponding patent applications, including a granted European patent which is in the process of being validated in 25 countries. MEDITOP Pharmaceuticals Ltd. has established close research relations with Hungarian scientific universities, such as the medical and pharmaceutical departments and institutes of the universities of Budapest, Debrecen, Szeged and Pécs.
Drug formulations, like drug molecules, are unique. MEDITOP Pharmaceuticals Ltd. starts every drug development project with a detailed development plan, which is structured to meet the Quality by Design (Qbd) development requirements of the health authorities.
The drug development strategy is based on a thorough analysis of preformulation data. In some cases, development is significantly challenging, for example when the bioavailability of the active substance is low, its water solubility and/or permeability is poor, and its physiological stability is poor. The development process should be designed to develop a drug formulation that helps overcome these problems.
MEDITOP Pharmaceuticals Ltd.'s process of developing a pharmaceutical formulation based on the principle of risk analysis of critical material properties and critical process parameters to ensure high quality of products, the main steps of which are as follows:
- Preformulation solubility and pre-stability studies
- Extensive excipient compatibility testing
- Laboratory-scale production
- Development and validation of analytical methods for the formulation
- Optimisation and finalisation of the dosage form
- Optimisation of manufacturing technology
- Pilot scale production
- Validation of the manufacturing technology process
- Stability studies
- Compilation of documentation