Granuliranje pomoćne tvari farmaceutske industrije prevrtanjem na kosom disku

undergraduate thesis

• Title (english): Tumble granulation of pharmaceutical excipient using inclined disc unit
• Author: Iva Gavran
• Mentor: Krunoslav Žižek (mentor)
• Committee member: Krunoslav Žižek (predsjednik povjerenstva)
• Committee member: Gordana Matijašić (član povjerenstva)
• Committee member: Zvjezdana Findrik Blažević (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2016-07-08, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Chemical Engineering; Mechanical, Thermal and Separation Processes

Abstract

U ovome je radu sagledano mokro granuliranje prevrtanjem kao moguća procesna tehnologija za pripravu pogodne formulacije farmaceutske tvari saharoze u svrhu dobivanja tableta dobrih primjenskih svojstava pri procesnoj tehnologiji tabletiranja. Testovi šaržnog granuliranja provedeni su prevrtanjem praškaste tvari u procesnoj geometriji kosog diska u laboratorijskom mjerilu. U fizičkoj pretvorbi tvari dodatno je korišten zrak i vezivo, vodena otopina polivinilpirolidona čiji je kolektiv kapljica dodavan raspršivanjem. Studij fenomena granuliranja u laboratorijskom mjerilu usmjeren je k pronalaženju procesnih uvjeta i sastava veziva koji će sinergističkim djelovanjem upravljati mikro- i mezorazinskim događajima na povoljan i ciljani način te time rezultirati kolektivom postojanih okrupnjenih jedinki, granula saharoze. Detektirane promjene svojstva kolektiva jedinki, raspodjele veličina čestica, s vremenom granuliranja ukazuju na doseg fizičke pretvorbe farmaceutske tvari u procesu granuliranja. Proces sadržane pretvorbe tvari modeliran je mehanističkim pristupom, primjenom populacijske bilance. Pristup modeliranja populacijskom bilancom u ovom radu podrazumijeva ispitivanje mogućnosti primjene 1-D populacijske bilance u diskretiziranom obliku te Size-Independent Kernel (SIK) modela koalescencije u simuliranju stvarne promjene raspodjele veličina čestica saharoze s vremenom. Primijenjeni pristup ukazuje na zastupljenost sadržanih mehanizama u procesu granuliranja. Metodom optimizacije, očitovanom u minimiziranju ukupne sume kvadrata odstupanja, procijenjen je karakterističan procesni parametar, konstanta brzine koalescencije. Time, kvantificirana je kinetika fizičke pretvorbe saharoze u stohastičkom okruženju kosog diska.

Abstract (english)

In this thesis, wet tumble granulation is scrutinized as a potential process technology for formulation of pharmaceutical substance, saccharose in order to produce tablets with good end-use properties in a tabletting process technology. Batch granulation tests were performed by tumbling of powder substance in process geometry of inclined disc in a lab-scale. Air and binder, water solution of polyvinylpyrrolidone whose droplet population is added by spraying, are additionally used in physical conversion of a substance. Study of the granulation phenomenon in a lab-scale is focused towards detection of process conditions and binder composition that will synergically drive micro- and meso-scale events in a favourable and aimed way and therewith result in a collective of stable enlarged entities, saccharose granules. Detected changes of the property of a group of entities, particle size distribution (PSD) with respect to granulation time point to the extent of physical conversion of pharmaceutical substance within granulation process. Process of underlying conversion of a substance is modelled with mechanistic approach using population balance. Such modelling approach in this thesis implies testing the applicability of a 1-D discretized population balance with Size-Independent Kernel (SIK) coalescence model for simulation of real temporal changes of saccharose PSD. Used approach indicates the contributions of underlying mechanisms in the granulation process. Optimization method that connotes minimizing the overall sum of squared errors is used for estimation of characteristic process parameter, coalescence rate constant. Thus, kinetic of physical conversion of saccharose in a stochastic environment of an inclined disc is quantified.

• Keywords: mokro granuliranje prevrtanjem; kosi disk; pomoćna tvar; saharoza; raspodjela veličina čestica; modeliranje procesa; populacijska bilanca
• Keywords (english): wet tumble granulation; inclined disc; excipient; saccharose; particle size distribution; process modelling; population balance
• Language: croatian
• URN:NBN: urn:nbn:hr:149:667496
• Study programme: Title: Chemical Engineering - Undergraduate study; Study programme type: university; Study level: undergraduate; Academic / professional title: sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva (sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Repository: Repository of Faculty of Chemical Engineering and Technology University of Zagreb
• Created on: 2017-12-05 09:23:06