Amorphous solid dispersions are a mixture of the API and a polymer which are co-processed to improve solubility.
About the Project
In order to keep the final tablet weight as low as possible, the concentration of the solid dispersion is required to be high within the tablet. As the solid dispersion will form the majority of the tablet, understanding the compression properties are important for tableting success, and to stop challenges occurring later in development.
For this project, we compared the compaction characteristics of prototype solid dispersion complexes. We carried out a Heckel test on the material. We assessed the yield pressure at fast and slow speeds to calculate the strain rate sensitivity. This gave valuable information to the formulators about the risk of elasticity of the materials used during tabletting. Speed sensitivity can cause problems in scale-up, therefore it is important to identify the risks and mitigate against them in the formulation.
The compact strength was measured during the test, so that the contribution to the final tablet strength could be estimated.
The Results
This batch of solid dispersion was very low density and fluffy, which could cause challenges to arise during tableting We were able to carry out roller compaction simulation on a blend of the SDD with three formulation excipients to predict the strength of ribbons. The blend was hand weighed into the die and made into simulated ribbons over a wide range of solid fractions (0.5 to 9.0 SF). The batch size of blend required to do this was only 15 g. We were able to provide an assessment of the formulation via tabletability, compatibility and compressibility testing. This will guide and speed up formulation development, save API through more efficient decision making, which, in turn, will save money in the final large-scale manufacture.
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