Effect of process parameters in high shear granulation on characteristics of a novel co-processed mesoporous silica material

Baumgartner, Ana (avtor), Planinšek, Odon (avtor)

In this study, insights into the development and optimization of a co-processed excipient based on mesoporous silica are presented. The main advantage of such a material is that it is appropriate for direct tablet compression and has a sufficiently large specific surface area to be suitable for potential subsequent drug loading and formulation of (amorphous) solid dispersions. Our aim was to use a Design of Experiments approach to investigate which process parameters in high shear granulation affect the characteristics of such a co-processed material. The parameters included were the amount of binder (isomalt), the amount of water (granulation liquid), the water addition rate and the speed of the impeller. The responses evaluated and modelled were particle size and its distribution, specific surface area, bulk density, flowability, compressibility and compactibility. The models obtained showed good quality in terms of goodness of fit and predictive power. Active effects were identified for all responses, giving a thorough insight into factors affecting the material characteristics. Optimization experiments resulted in products with the desired characteristics (high specific surface area, large particle size, good flow and compression properties) and confirmed the validity of the generated models.

• Jezik: Angleški jezik
• Ključne besede: mesoporous silica, high-shear granulation, design of experiment, co-processing, excipient
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2023
• Št. strani: 15 str.
• Številčenje: Vol. 188, art. 106528
• PID: 20.500.12556/RUL-148361
• UDK: 615.45+615.015.14
• ISSN pri članku: 0928-0987
• DOI: 10.1016/j.ejps.2023.106528
• COBISS.SI-ID: 160783619
• Datum objave v RUL: 18.08.2023

Gradivo je del revije

• Naslov: European Journal of Pharmaceutical Sciences
• Skrajšan naslov: Eur. j. pharm. sci.
• Založnik: Elsevier
• ISSN: 0928-0987
• COBISS.SI-ID: 17553413

Licence

• Licenca: CC BY-NC-ND 4.0, Creative Commons Priznanje avtorstva-Nekomercialno-Brez predelav 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by-nc-nd/4.0/deed.sl
• Opis: Najbolj omejujoča licenca Creative Commons. Uporabniki lahko prenesejo in delijo delo v nekomercialne namene in ga ne smejo uporabiti za nobene druge namene.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: mezoporozni silicijev dioksid, granulacija z visokim strigom, načrt poskusa, soobdelava, pomožne snovi, farmacevtske oblike, dostavni sistemi

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P1-0189
• Naslov: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih