IriSys Pharmaceutical Product Services
Pharmaceutical Dosage Form Development

Archive for June, 2009

Case Study X: Poor Solubility and Rapid Degradation in Acid

Friday, June 19th, 2009

Irisys was challenged to formulate for oral administration a compound characterized by low solubility in both water and oil, which also degraded rapidly in acid.  As might be expected bioavailability in preliminary trials was poor.  A semi-solid matrix was developed that required heating to liquify for capsule filling. Capsules were enteric coated to protect active ingredient from degradation in acid.  Dog and human studies showed significant improvement in bioavailability.