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

Baumgartner, Ana (author), Planinšek, Odon (author)

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.

• Language: English
• Keywords: mesoporous silica, high-shear granulation, design of experiment, co-processing, excipient
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2023
• Number of pages: 15 str.
• Numbering: Vol. 188, art. 106528
• PID: 20.500.12556/RUL-148361
• UDC: 615.45+615.015.14
• ISSN on article: 0928-0987
• DOI: 10.1016/j.ejps.2023.106528
• COBISS.SI-ID: 160783619
• Publication date in RUL: 18.08.2023

Record is a part of a journal

• Title: European Journal of Pharmaceutical Sciences
• Shortened title: Eur. j. pharm. sci.
• Publisher: Elsevier
• ISSN: 0928-0987
• COBISS.SI-ID: 17553413

Licences

• License: CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nc-nd/4.0/
• Description: The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

Secondary language

• Language: Slovenian
• Keywords: mezoporozni silicijev dioksid, granulacija z visokim strigom, načrt poskusa, soobdelava, pomožne snovi, farmacevtske oblike, dostavni sistemi

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P1-0189
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih