Sušenje aktivne farmaceutske supstance u sušioniku sa raspršivanjem

master's thesis

• Title (english): Spray drying of active pharmaceutical ingredients
• Author: Ana Klobučić
• Mentor: Jasna Prlić Kardum (mentor)
• Committee member: Jasna Prlić Kardum (predsjednik povjerenstva)
• Committee member: Aleksandra Sander (član povjerenstva)
• Committee member: Mirela Leskovac (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2016-07-14, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Chemical Engineering; Mechanical, Thermal and Separation Processes

Abstract

Slaba topljivost i bioraspoloživost novosintetiziranih farmaceutskih molekula uvijek predstavlja izazov pri izradi djelotvornog lijeka. Amorfne čvrste disperzije dobivene sušenjem s raspršivanjem mogu učinkovito nadići te probleme. Sušenje s raspršivanjem je tehnika prevođenja pojne smjese iz kapljevitog u čvrsto stanje uvođenjem otopine u struju vrućeg plina. Procesni uvjeti sušenja imaju veliki utjecaj na granulometrijska i morfološka svojstva te strukturu produkta, a time i primjenska svojstva proizvoda. U ovom radu istražena je mogućnost dobivanja stabilne čvrste disperzije aktivne farmaceutske supstance i polimernog nosača. Pripremljena otopina kristalne hidroklorne aktivne supstance i polimera u sustavu vode i acetonitrila sušena je pri različitim ulaznim temperaturama, protocima plina za raspršivanje i pojne smjese te različitim promjerima otvora dizne atomizera. Konačni produkt okarakteriziran je različitim analitičkim i fizikalnim metodama i ustanovljeno je kako uvjeti provedbe sušenja utječu na konačna svojstva suhog produkta. Rezultati su pokazali kako sušenjem s raspršivanjem nastaju stabilne čvrste disperzije amorfne strukture. Farmaceutska supstanca je visoke čistoće. Definirani su i optimalni uvjeti sušenja.

Abstract (english)

Poor solubility and bioavailability of newly synthetized drug always pose challenge in the developement of efficient pharmaceutical formulation. Amorphous solid dispersions based on spray drying technology, can succsesfully overcome that issues. Spray drying is the transformation of feed from fluid state into a dried pharmaceutical form by spraying the feed into a hot drying medium. Process conditions influences the granulometric and morphological properties and structure of the product, and consequently determines the application properties of the final product. This paper examined the possibility of obtaining a stable amorphous solid dispersion of an active pharmaceutical ingredient and polymer carrier in a spray-dryer. A solution of the hydrochloride crystalline structure of the active pharmaceutical ingredient and polymer in a mixture of water and acetonitrile was dried at different temperatures, flow rates of gas used for atomization, as well as the flow rates of the solution and different nozzle tip diameters. The final dried products were characterized and identified with a variety of analytical and physical methods. The influence of the examined process conditions on the final product properties has been analyzed. The results showed that stable amorphous solid dispersion was prepared by spray drying. Pharmaceutical substance is of high purity. Optimal process conditions are defined.

• Keywords: čvrsta disperzija; sušenje s raspršivanjem; procesni parametri; karakterizacija
• Keywords (english): solid dispersion; spray drying; process conditions; characterization
• Language: croatian
• URN:NBN: urn:nbn:hr:149:932707
• Study programme: Title: Chemical Engineering - Graduate study; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra inženjer/inženjerka kemijskog inženjerstva (magistar/magistra inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2017-07-06 08:53:41