Optimalizace krystalizace aktivních farmaceutických substancí

Abstract

The theme of this bachelor thesis is optimization of crystallization of active pharmaceutical ingredients. Nicergoline is the substance used for each crystallization experiment. All experiments and their subsequent characterization were performed in the pharmaceutical company Teva Czech Industries s. r. o. in its research and development department in Opava-Komárov. Furthermore, this company has already been producing Nicergoline for a long time. The practical part is describing recrystallization of crystalline substance of heterocyclic organic compound by different methods of crystallization followed by its characterization. Instrumental methods were used for the characterization, in order to be comparable to the results of all crystallization experiments. Recrystallization of Nicergoline was performed in five different ways. Dried crystalline substance is characterized by X-ray powder diffraction, scanning electron microscope and powder rheometer. Results of the gas chromatography show the content of the residual solvents. The results of the analyses illustrate variety of prepared materials that differ greatly in all examined parameters. The crystallization conditions such as temperature cooling profile or the initiation of nucleation method have been proved to have a significant effect on the physicochemical properties of the active pharmaceutical ingredients. The methods and the procedures, when working with Nicergoline, meet the requirements of good manufacturing practice. These methods and the procedures are commonly used in the whole pharmaceutical industry.