Development of orodispersible tablets with solid dispersions of fenofibrate and co-processed mesoporous silica for improved dissolution

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

Poor water solubility is an important challenge in the development of oral patient-friendly solid dosage forms. This study aimed to prepare orodispersible tablets with solid dispersions of a poorly water-soluble drug fenofibrate and a co-processed excipient consisting of mesoporous silica and isomalt. This co-processed excipient, developed in a previous study, exhibited improved flow and compression properties compared to pure silica while maintaining a high specific surface area for drug adsorption. Rotary evaporation was used to formulate solid dispersions with different amounts of fenofibrate, which were evaluated for solid state properties and drug release. The solid dispersion with 30% fenofibrate showed no signs of crystallinity and had a significantly improved dissolution rate, making it the optimal sample for formulation or orodispersible tablets. The aim was to produce tablets with minimal amounts of additional excipients while achieving a drug release profile similar to the uncompressed solid dispersion. The compressed formulations met the requirements for orodispersible tablets in terms of disintegration time, and the drug release from best formulation approximated the profile of uncompressed solid dispersion. Future research should focus on reducing the disintegration time and tablet size to enhance patient acceptability further.

• Language: English
• Keywords: co-processed excipient, fenofibrate, amorphous solid dispersion, orodispersible tablets, direct compression, dissolution enhancement
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2024
• Number of pages: Str. 1-9
• Numbering: Vol. 16, iss. 8, [art.] 1060
• PID: 20.500.12556/RUL-164727
• UDC: 544.351.3+66.061:615.45
• ISSN on article: 1999-4923
• DOI: 10.3390/pharmaceutics16081060
• COBISS.SI-ID: 204275715
• Publication date in RUL: 08.11.2024

Record is a part of a journal

• Title: Pharmaceutics
• Shortened title: Pharmaceutics
• Publisher: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: soobdelana pomožna snov, fenofibrat, amorfna trdna disperzija, orodisperzibilne tablete, neposredno stiskanje, izboljšanje raztapljanja, tablete, farmacevtske oblike

Projects

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