Orodispersible Films: A Delivery Platform for Solid Lipid Nanoparticles?

To overcome the poor bioavailability observed for many newly developed active pharmaceutical ingredients (APIs), an appropriate formulation strategy is necessary. One approach is the formulation of these substances in solid lipid nanoparticles and their further processing into solid dosage forms. A promising and innovative oral delivery platform could be orodispersible films (ODFs). ODFs were already investigated more closely, e.g., for the administration of API nanoparticles, and proved their suitability for this formulation approach. The current study was aimed at investigating if the HPMC (hydroxypropyl methyl cellulose) film matrix is also suitable to serve as an appropriate delivery platform for solid lipid nanoparticles. Dependent on the type of triglyceride nanoparticles embedded in the film matrix and the formulation of the lipid particles, lipid contents of up to 54 wt.% could be realized in the film matrix without the loss of the nanoparticulate state. Good mechanical properties were confirmed for these films by determining the tensile strength as well as the elongation before breakage. Interestingly, processing of a lipid suspension into this solid dosage form led to a significantly reduced transformation of the lipid particles from the metastable alpha- into the stable beta-polymorph. This could prove very beneficial when the lipid particles are loaded with APIs.

Automated summary

This study aimed to investigate the suitability of using HPMC film matrix as a delivery platform for solid lipid nanoparticles, showing that lipid contents of up to 54 wt.% could be achieved in the film matrix without affecting the nanoparticle state and mechanical properties of the films. Additionally, processing lipid suspension into solid dosage form led to reduced transformation of lipid particles, which could be beneficial for APIs loaded lipid particles.