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Project

Investigation of bead coating as manufacturing process for the development of amorphous solid dispersions.

The number of drug molecules that show poor aqueous solubility and low dissolution rate has significantly increased during the past two decades, resulting in low oral bioavailability. Among the different formulation strategies that are being studied and applied to overcome this solubility issue, the dispersion of a poorly soluble drug in an inert polymer matrix to form amorphous solid dispersions (ASDs) is a very promising one. Spray drying is an established and industrially applied manufacturing process for ASDs. Although commercial products have been developed based on this process, spray dried ASDs require down-stream processing steps to obtain dosage forms (e.g. tablets) acceptable to be administered to patients. These steps can imply physical stability issues and thus nullifies the initial solubility advantage of the ASD. We therefore want to investigate if coating of ASDs on inert beads, can be considered as a valuable alternative for spray drying (main research question). The main anticipated advantage of this process is that the coated beads can be readily administered to patients (via capsule formulations), hence  avoiding potential detrimental down-stream processing and that the dose can easily be adapted to the need of the individual patient (personalised medicine). An in depth investigation of the role of the process and formulation parameters on the physical structure and pharmaceutical performance of the ASD will enable us to answer our main research question.

Date:1 Nov 2019 →  24 Oct 2023
Keywords:solid dispersions
Disciplines:Pharmaceutical technology
Project type:PhD project