Bioavailability of Poorly Soluble Drugs: a Challenge for the Pharmaceutical Industry
According to the AAPS Journal published by the American Association of Pharmaceutical Scientists, approximately 40% of top 200 major market oral drugs are poorly soluble (BCS Class II or Class IV). Further, according to the Drug Development & Delivery Journal, approximately 90% of new chemical entities (NCEs) in development were either BCS Class II or Class IV drugs.
The Accordion Pill has demonstrated an enhancement of the absorption of a poorly soluble, BCS Class II/IV drug in a crossover PK clinical study in 12 healthy volunteers.
The following chart depicts the Accordion Pill’s capability to improve the PK of an undisclosed, poorly soluble BCS Class II/IV drug that is currently available on the market.
The results of our clinical trial have demonstrated approximately a 100% increase in bioavailability in 12 healthy volunteers with our Accordion Pill technology, as compared to the commercial formulation of the drug. Furthermore, the results demonstrated that the increase in bioavailability obtained when administering one Accordion Pill and two Accordion Pills was proportional to the increase in dosage, or linear absorption, whereas the commercial formulation does not show linear absorption in these dosage ranges.