Vliv sekundární nukleace na fyzikální vlastnosti aktivních farmaceutických substancí

Abstract

The diploma thesis is focused on the discovery of physical and physical-chemical properties of Nicergoline. The substance was prepared using various recrystallizations’ processes of applying secondary nucleation. In the theoretical part, the author describes the nucleation and put forwards mechanisms of the secondary nucleation. Here, instrumental methods are also described which are either the researched properties of solid crystalline materials or are used for crystallization in pharmaceutical industry. The instrumental methods discussed above will be utilized during the course of these experiments. The practical part of the thesis details the conditions of experiments, including measuring and conditions of measuring during the characterization process of Nicergoline. The crystallization experiments were undertaken by the help of seeding, ultrasonic probe, ultrasonic flow cell and templates Zirmil® Y. For each of the prepared batches, measurements were made as per particle size distribution, analysis of acetone residue and image analysis on scanning electron microscopy. The selected batches were measured for rheology properties and surface energy. These selected batches were also submitted to undergo atomic force microscopy. The results of the individual experiments demonstrate that the conditions such as the quantity of seeding material, time of initiations by ultrasound or the diameter of ceramic balls influence properties resulting crystals. Towards the end of the thesis results are compared with different crystallization methods and are compared among various batches uniformly. The preparation and characterization were made at a well-equipped workplace, under a specialized environment which complied with the current good manufacturing practice requirements.