The Company performed an exploratory pre-clinical trial with Beagle dogs in order to:
a. Design novel Accordion Pills based on unfolding multilayer polymeric films
b. Investigate the mechanism of gastric retentivity in dogs
c. Assess the effect of compounding a narrow absorption window drug in an Accordion Pill™ on the drug's absorption properties.

Dosage forms (DFs) with different dimensions and mechanical properties were administered to dogs with acidic buffer (pH=1.5). Gastric retention time (GRT) was determined by X-ray. The absorption of Riboflavin or L-DOPA from a prototype Accordion Pill ™ was compared with a non-gastric-retentive controlled release DF and to an oral solution of the drug.

The extended absorption phase (>48h) of Riboflavin (100mg) administered in a Accordion Pill™ showed a 4-fold increase in oral bioavailability. The L-DOPA Accordion Pill™ maintained therapeutic L-DOPA concentrations (>500 ng/ml) for over 9 hours.

The Accordion Pill™ produces gastric retentivity that can be used to improve the absorption profile towards the gut.