Model-based description of disintegration time and dissolution rate of nanoparticle-loaded orodispersible films

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Denise SteinerArno Kwade

Abstract

The embedding of nanoparticles in orodispersible films (ODFs) is an innovative strategy to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (API). As the films are supposed to disintegrate within seconds when placed in the mouth, the disintegration time of the ODFs as well as the dissolution behavior of the API are of great interest. This study introduces a new possibility for a model-based description of these film properties to enable a prediction for the process layout for the manufacturing of the nanoparticle-loaded ODFs. Furthermore, this fundamental understanding can provide information on process robustness as a tool applied in future Quality by Design (QbD) approaches. The disintegration times of the nanoparticle-containing ODFs were measured with the SFaB method (slide frame and ball) and could be mathematically described considering the impact of the particle load and the dry film thickness on the disintegration behavior. Furthermore, it is considered if the films are disintegrated at the calculated time with a probability of 50% or any other probability. Besides the disintegration time, a clear influence of film parameters like the particle load, size of the embedded particles, fi...Continue Reading

Citations

Aug 7, 2019·Expert Opinion on Drug Delivery·Yu TianJ Carolina Visser
Apr 14, 2020·Nanotechnology, Science and Applications·Nasrul WathoniMuchtaridi Muchtaridi
Jun 8, 2021·International Journal of Pharmaceutics·Mengning HeQingliang Yang

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