|Abstract:||There is a number of methods known in the pharmaceutical industry for determining the size of particles of a pharmaceutical substance, which are differentiated according to the determination principle and by this according to the received results. There has lately been much progress in the development in this field, meaning that all kinds of particle sizes, either those in suspension (eg nasal sprays) or as dust particles, can be determined nowadays quickly and routinely.
The present master thesis presents the determination of the particle size of a pharmaceutical substance using optical microscopy and its confirmation using the raman microscopy. The first method involved an optical microscope with a camera as well as an adequate software for picture analysis. The software made it possible to manually select the analyzed particles, so we selected the particles on our own. This method gave us the particle size. By means of the second method – the raman microscopy – using the raman microscope Renishaw inVia and the adequate software – we were able to confirm the correct selection of particles based on the raman spectrum.
As the pharmaceutical substance, mometasone furoate was selected, and a comparison was made with two other pharmaceutical substances, namely budesonide and fluticasone furoate, contained in a nasal spray. The mentioned pharmaceutical substances in a nasal spray help relieve allergic rhinitis symptoms. Besides substance, nasal sprays contain also an avicel RC-591 phase serving as an auxiliary substance influencing the viscosity of samples. The avicel phase (RC-591) was not a subject of our interest as regards the determination of the particle size. The present master thesis compares all three substances, both generics and references, among themselves.
The results have indicated that by using the raman microscope Renishaw inVia we were able to confirm the correct selection of particles of the substances mometasone furoate, budesonide, and flutikasone furoate in a nasal spray and not the avicel RC-591 particles.
It can be noticed from the particle size analysis that there is no difference between the generics and reference samples and that all analyzed nasal suspensions have substance particles of the same size. The particle size in the mometasone furoate and flutikasone furoate substances is 9 μm, whereas the particles in budesonide are a bit bigger, namely 10 μm.
By means of the raman microscope Renishaw inVia, the hypothesis that the avicel RC-591 can be optically distinguished from mometasone furoate, flutikacone furoate, and budesonide, has been confirmed.|