Determination of the influence of the process parameters on the size and zeta potential of the particles produced by spray drying

U okviru ovog diplomskog rada uspješno je proveden i evaluiran plan pokusa sa svrhom ispitivanja utjecaja procesnih parametara na veličinu i naboj mikročestica s melatoninom pripravljenih tehnikom sušenja raspršivanjem. Poznavanje veličine čestica ishodnih sirovina te gotovih pripravaka važno je za terapijski učinak lijeka, stabilnost, oblikovanje i skladištenje. Naboj na površini čestica uvjetuje stabilnost uzorka, koja se manifestira većom otpornošću na flokulaciju i agregaciju čestica. Za dizajniranje plana pokusa te statističku obradu dobivenih podataka analize mikročestica s melatoninom korišten je JMP program. Temeljem statističke obrade utvrdili su se faktori s najvećim utjecajem na ispitivani parametar. Mijenjanjem procesnih parametara brzine pumpe (20-40 %), omjera lipida i kitozana (31,25-62,5) te temperature zraka (110-125 °C) dobiveno je 13 uzoraka mikročestica koje se razlikuju u veličini i vrijednosti Z-potencijala. Metodom linearne regresije nije dobivena krivulja koja pokazuje povezanost između predviđenih i dobivenih veličina čestica. Stoga je utvrđeno da u ispitanom području omjera lipida i kitozana, brzine pumpe te temperature sušenja ne dolazi do značajne promjene u veličini pripravljenih čestica. Matematičkom analizom JMP programa utvrđeno je da najveći utjecaj na vrijednost Z-potencijala ima omjer lipida i kitozana što je i očekivano budući da kitozan nosi pozitivan, a lipidna komponenta negativan naboj. Temperatura zraka ima umjeren utjecaj na Z-potencijal, dok brzina pumpe ima slabi utjecaj.Within this graduate thesis, a plan of experiments whose purpose was to examine the influence of process parameters on the size and charge of micro particles containing melatonin prepared using the spray drying technique was successfully carried out and evaluated. Knowing the size of the raw materials as well as the size of particles in the drug product is important for the therapeutic effect, stability, shaping and storage of the medication. The particles' surface charge influences the stability of the sample, which is manifested in a greater resilience to flocculation and aggregation of the particles. In order to design the experiment plan, and for the statistical analysis of the data acquired from the analysis of the micro particles containing melatonin the JMP program was used. The factors with the biggest influence on the target parameter were determined by the statistical analysis. By changing the process parameters of the pump speed (20-40 %), the lipid-chitosan ratio (31,25-62,5) and the air temperature (110-125 °C), 13 micro particle samples which differed in size and Z-potential values were obtained. Using the method of linear regression did not result in a curve that showed the linear relation between the predicted and obtained particle sizes. Therefore, it was determined that in the tested lipid-chitosan ratio, pump speed and drying temperature there were no significant changes in the size of the prepared particles. The mathematical analysis of the JMP program determined that the lipid-chitosan ratio has the biggest influence on the Z-potential value, which was expected seeing as chitosan carries a positive, whereas the lipid component carries a negative charge. The air temperature has a moderate influence on the Z-potential, while the speed pump has a weak influence