Bonhoeffer, Bastian, Kwade, Arno and Juhnke, Michael (2018) Alternative manufacturing concepts for solid oral dosage forms from drug nanosuspensions using fluid dispensing and forced drying technology. Journal of pharmaceutical sciences, 107 (3). pp. 909-921. ISSN 00223549

Abstract

Flexible manufacturing technologies for solid oral dosage forms, which enable a continuous
adjustability of the manufactured dose strength, are of interest for applications in
personalized medicine and continuous manufacturing. This study explored the feasibility of
using micro-valve technology for the manufacturing of different solid oral dosage form
concepts. Hard gelatin capsules filled with excipients, placebo tablets and polymer films,
placed in hard gelatin capsules after drying, were considered as substrates. Suitable matrixformers,
present either on the substrate or directly in the drug nanosuspension, proved to be
essential to prevent agglomeration of the drug nanoparticles and to ensure a fast dissolution
behavior. For all three concepts, solid oral dosage forms with adequate dissolution behavior
could be manufactured by adjusting the substrate’s and drug nanosuspension’s composition.
Furthermore, convection and radiation drying methods were investigated for the fast drying
of film based dosage forms. For increasing drying intensity, changes in morphology and
inhomogeneity of the drug and matrix-former distribution were observed. However, even
fast drying times below one minute could be realized, while maintaining the nanoparticulate
drug structure and a good dissolution behavior.

Item Type:	Article
Date Deposited:	15 Mar 2018 00:45
Last Modified:	15 Mar 2018 00:45
URI:	https://oak.novartis.com/id/eprint/32805