Solid oral delivery – poorly soluble API
The vast majority of compounds in development are poorly soluble. Obviously it is essential to et systemic exposure from an oral dosage form in order to demonstrate efficacy in a clinical trial. To do this it is vital to give careful thought and carry out the work that is necessary for that specific compound at that stage in development.
Strategies for poorly soluble compounds start with selecting the best form through salt selection or co-crystal formation and progress to control of size, maybe micronized or nano-sized.
Other strategies include amorphous dispersion, by spray drying or hot melt extrusion and lipid based formulations.
Advice can be provided on strategy, outsourcing partner selection, outsource management and data interpretation. The aim is to ensure that you do just what is needed for the stage of development that you are at.
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