Ostemax 70 comfort awarded The Economic Prize of The President of The Republic of Poland

A team of scientists from the Gdańsk University of Technology led by Professor Janusz Rachoń and Polpharma have been jointly awarded the Economic Prize of the President of the Republic of Poland in the “Best Product or Technology Invention” category for the development of a new, entirely original method of manufacturing alendronate sodium, one of the most effective compounds used to treat osteoporosis. Ostemax 70 comfort, which is based on this compound, has given many patients access to a modern and effective osteoporosis treatment (the medication only has to be taken once a week).

The new method of manufacturing alendronate sodium jointly developed by the Gdańsk University of Technology and Polpharma as well as the subsequent production of the
Ostemax 70 drug based on this compound have been entirely Polish achievements. At the same time these are very good examples of how the scientific potential of a domestic university and original Polish technology can be utilised in collaboration with the business community.

The new method of alendronate sodium synthesis has been developed by a team comprising employees from both partners. It was fully implemented by the Polpharma company, which manufactures the active substance as well as the finished dosage form (70 mg) and has registered the Ostemax 70 comfort drug. The utilisation of the results of Polish scientific research in the drug manufacturing process has made the Polish manufacturer one of the leading producers of the compound used to treat osteoporosis. Moreover, the fact that the active substance can be synthesised at Polpharma has made the company independent from foreign suppliers.

Collaboration between the company and the scientific community enables the deployment of new technologies developed at Polish universities on a production scale and accelerates the technological progress of the Polish economy. While introducing Ostemax 70, Polpharma has increased its involvement in social and educational programmes aimed at disseminating knowledge about the possibilities for preventing osteoporosis fractures and preventing osteoporosis itself. Direct treatment using a modern medication which is much cheaper than its foreign-made counterparts and education initiatives aimed at enhancing health awareness both contribute to the improvement of the health of Polish society and limit the considerable expense to the central budget of treating osteoporosis complications.

The new method of manufacturing alendronate sodium, which is the active ingredient of Ostemax 70 comfort, was developed at the Gdańsk University of Technology. The idea for the project was originated by Professor Janusz Rachoń whose team of scientists have developed an entirely original way of synthesising alendronate sodium.

The synthesis method developed by scientists from Gdańsk is not only cheaper but also much more environmentally friendly than the methods used previously.

An innovative solution has been used — semi-finished products are obtained directly in situ in the reaction mixture. In the methods used previously, two stages were necessary — semi-finished products were first obtained separately. Here, the two stages were combined by selecting appropriate reaction conditions as well as the types and quantities of reacting substances. As a result, two key synthesis reactions could be linked in a mutually complementary manner, ensuring a successful manufacturing process.

The process also uses a different solvent to those used previously. A pure product in an appropriate crystallographic form is obtained after the reaction mixture has been concentrated.

Finished product samples were analysed using liquid chromatography and nuclear magnetic resonance, which enabled the rapid identification of semi-finished products and products of the reaction as well as the control of process yield and impurity levels by a precise determination of the fraction of substrates reacted in the reaction mixture.

Polpharma have managed to implement this process on a production scale. Individual process parameters were determined and optimised, which enabled the synthesis of alendronate sodium to be conducted in the most economical and technologically advantageous manner. As a result, the invention was successfully implemented and used to manufacture Ostemax 70 comfort. The drug offers a comfortable treatment for osteoporosis, since it only has to be taken once a week.