Development of orodispersible polymer films containing poorly water soluble active pharmaceutical ingredients with focus on different drug loadings and storage stability.

The aim of this work was the development of orodispersible films containing different film forming polymers with focus on different drug loadings of two poorly water soluble APIs. Furthermore, physical stability of films was examined at two different storage conditions. Loperamide hydrochloride (LPH) and ibuprofen (IBU) were used as model drugs. Hydroxypropyl methylcellulose (HPMC) and three different types of hydroxypropyl cellulose (HPC) were used as film forming polymers. Suspensions were characterized with respect to their viscosity and particle sedimentation and films regarding their content uniformity, thickness, mass and stability. Principal component analysis (PCA) was used to evaluate the correlation between the wet film thickness, dry film thickness, mass of the films, API fraction in the suspension and the viscosity of the suspensions. The viscosity of the suspensions was dependent on the drug load and the polymer fraction but less so on the type of the utilized polymer. A correlation between the wet film thickness, the solid fraction and the mass of the films was established with an increase in mass by increasing the wet film thickness or the solid fraction. Films containing 50 mg IBU/6 cm(2) film led to acceptable films. Storage experiments did not lead to an AV below 15 in all cases after storage for three and six months, attributed to the storage conditions and the quality of the films. Nevertheless, the development and production of flexible and homogeneous films of LPH and IBU was successfully achieved.