Kontrola oblika kristala u postupku šaržne kristalizacije

Autor: Ždrakić, Marija
Přispěvatelé: Prlić Kardum, Jasna
Jazyk: chorvatština
Rok vydání: 2017
Předmět:
Popis: Kristalizacija kao jedan od važnijih procesa farmaceutske industrije podliježe razvitku novih tehnika u dizajnu čestica. Kao jedno od područja aktivnog istraživanja farmaceutske industrije pojavila se sferična kristalizacija zbog činjenice da omogućuje istovremenu aglomeraciju kristala i kristalizaciju. U ovom radu, u okviru šaržne kristalizacije, istraživan je utjecaj sustava (otapalo, antiotapalo, sredstvo za premošćivanje) na granulometrijska svojstva (veličinu i oblik) i strukturu nastalih kristala dronedaron-hidroklorida koji je aktivna komponenta lijeka za liječenje srčane aritmije. Odabirom pogodnog sustava pokušao se provesti postupak sferične kristalizacije. Nakon određivanja krivulja topljivosti provedena je kristalizacija za dva različita sustava koji su utjecali na veličinu i oblik kristala, ali ne i na strukturu. Nakon završetka procesa, oblik kristala praćen je svjetlosnim i stereo mikroskopom, dok je brzina otpuštanja dronedaron-hidroklorida praćena uređajem Dissolution tester RC-6D. In the pharmaceutical industry, the process of crystallization as one of the most important process, is subject of development of new techniques in particle design. Spherical crystallization has emerged as one of the areas of active research in the pharmaceutical industry. Spherical crystallization is a particle design technique, by which crystallization and agglomeration can be carried out simultaneously in one step. In this study, through the batch crystallization process, the effect of the system (solvent, antisolvent, bridging liquid) on the granulometric properties (size and form) and the structure of formed dronedarone-hydrochloride crystals, which is an active component of the drug for the treatment of cardiac arrhythmia, was investigated. After the selection a suitable system, the spherical crystallization process is carried out. Solubility of the salt has also been determined and the crystallization for two different systems was performed. It was found that the addition of different solvents affects the shape and the crystal size distribution, but not crystals structure. The shape of crystals was monitored with light and stereo microscope and the rate of release of dronedarone-hydrochloride was determined by the Dissolution tester RC-6D.
Databáze: OpenAIRE