The Accordion Pill®: unique oral delivery to enhance pharmacokinetics and therapeutic benefit of challenging drugs.

Accordion Pill® (AP) is a novel gastric-retention oral delivery platform based on folded multilayer films (Intec Pharma, Jerusalem, Israel). Phase II clinical trials have evaluated gastric retention and pharmacokinetics (PK) of AP in healthy volunteers and efficacy and safety of AP containing carbidopa and levodopa (AP-CD/LD) in patients with Parkinson's disease (PD). AP was retained in the stomach for approximately 8 h, without special meal requirements. AP-CD/LD demonstrated improved absorption, more stable levodopa exposure and improved ON time compared with immediate-release CD/LD in advanced PD patients. AP provides a novel treatment platform for improving PK and efficacy for drugs with narrow absorption windows or poor solubility. Furthermore, AP allows multiple drug release profiles in a single capsule and can provide fixed-dose combinations.