PK of various drugs with narrow absorption window is correlated with limited efficacy and safety profile and with the need for frequent daily dosing.
The Accordion Pill™ solution:
The Accordion Pill™ provides a significantly prolonged absorption phase for the drug, resulting in an improvement of PK parameters that are frequently correlated with the drug’s efficacy, safety and dose regimen, such as reduced peak to trough ratio and/or higher AUC.
An example for improving the PK of a narrow absorption drug – Levodopa (LD) for the treatment of Parkinsons’ disease.
AP-CDLD Phase II Clinical Trial – More stable Levodopa levels with significantly reduced peak-to-trough fluctuations
LD plasma levels in advanced PD patients following BID administration (8 hours apart) of AP-CD/LD 50/375 vs. QID administration (4 hours apart) of a commercial CD/LD formulation (equivalent daily dose). PK was performed on day 7, following 6 days of drug administration at home. No LD medication was allowed for 10 hours before the first administration at day 7.