Spray drying and further processing of lipid nanodispersions containing active ingredients into orodispersible tablets

01/04/2023 to 31/03/2026

The latest screening methods make it possible to identify promising new drug candidates. However, studies have shown that more than 80 % of these substances are poorly soluble in water. In order to increase the bioavailability of the substances, various formulation strategies have been developed in recent years. One very promising method, especially for lipophilic substances, is the formulation in lipid-containing carrier systems, such as lipid nanosuspensions or emulsions.
Solid dosage forms are particularly popular with patients. However, children and the elderly are usually unable to swallow a tablet or capsule as a whole. Therefore, innovative dosage forms such as orodispersible tablets (ODTs) are very attractive. They disintegrate in the mouth within 3 min, so the active ingredient can be swallowed directly.
The aim of the project is to use spray drying to produce powders from lipid nanosuspensions and emulsions containing active ingredients, which serve as an intermediate for the subsequent production of ODTs. Furthermore, by looking more closely at the state of the solid lipid nanoparticles during drying, the temperature stress on the particles during this step of the process will be investigated. In order to avoid recrystallization processes during storage of the powders, which could lead to reduced bioavailability of the active ingredient, the storage stability of the formulations is also examined in more detail. Finally, the production of ODTs from the drug-containing lipid powders is carried out. There, the focus is on the preservation of the (nanoparticulate) properties of the lipid carrier particles and the rapid dissolution of the ODTs in water.