Excipient interference on development of a cGMP assay for PDE5
Abstract
The aims of this study were to develop a simple, cost-effective assay for determination of PDE5 activity in vitro for testing of active compounds and excipients used in FDA approved products for treatment of erectile dysfunction. Several excipients used in formulations of these drugs interfered with the PDE5 assay indicating that certain excipients can exhibit pharmacological effects in vitro and are therefore not the inert materials they were described as in years past.
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