IriSys was requested to develop a hard gelatin liquid-filled capsule formulation to reduce intersubject bioavailability variability of a poorly water soluble, high dose compound.  Preformulation studies were performed.  Based on the physical chemical characteristics of the compound, excipient compatibility studies were conducted.  A saturation solubility study in lipophilic excipients showed that there were no individual solvents that provided sufficient solubility or that were compatible with hard gelatin capsules.  The study was expanded to include binary and ternary excipient systems that would provide adequate solubility and be compatible with hard gelatin capsules.  A formulation was selected and studied for stability.  The final formulation of the hard gelatin liquid-filled capsule was stable and over time demonstrated compatibility with the non-active components.  Dissolution testing showed complete release in 30 minutes.

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