Intec delivery tech tackles poor bioavailability
clinical trial showing that its drug delivery platform can extend
the release of an active ingredient in the upper gastrointestinal
tract for more than six hours and double its absorption.
The gastroretentive platform, called Accordion Pill, has been designed to deliver drugs that must be absorbed by the body in what is known as the narrow absorption window, the intestine segment below the stomach. And the results of the study suggest that it is the first technology of its type to achieve this level of retention and absorption, according to the company.
The study, conducted on healthy volunteers at the Sheba Medical Centre in Israel, used riboflavin (vitamin B2) as a model active ingredient to demonstrate the capability of the Accordion Pill formulation to prolong absorption of pharmaceuticals into the blood. The prolonged absorption enables greater bioavailability while reducing dosage and side effects.
Many important pharmaceutical compounds are limited in their therapeutic action because insufficient amounts are absorbed into the body through this area, and Intec estimates that the technology addresses a market for drugs with inadequate bioavailability that is valued at more than $50 billion.
Efi Cohen-Arazi, the company's CEO, said: "this is a major milestone, positioning Intec Pharma as a leader in the gastric retention field."
The Accordion Pill is made up of a biodegradable, hydrophilic polymer, recognized as safe according to the US Food and Drug Administration (FDA)'s GRAS (Generally Recognised As Safe) standard. The enteric polymer matrix is substantially insoluble in gastric fluids at pH levels of less than 5.5. This enables it to be retained in the stomach, enabling it to deliver its drug payload slowly, in a controlled manner.
Once in the stomach, the polymer expands and unfolds - much like an accordion, and so cannot pass through the valve at the base of the stomach. It therefore releases active drug into the stomach and upper intestinal section, only passing through the GI tract when a considerable portion of the pill has been dissolved.
The study was based on crossover data from 13 healthy volunteers who received alternate 75 mg doses of Accordion Pill riboflavin and regular immediate release riboflavin following a low calorie meal (280 calories). Results showed that the Riboflavin Accordion Pill was retained in the stomach and continued to release Riboflavin to its absorption sites for significantly longer periods of time than regular Riboflavin.
The researchers found that the stomach retention time for Accordion Pill riboflavin was more than six hours compared to less than two hours with regular riboflavin, while the absorption time was eight hours compared to three hours, respectively.
The study results were presented by Prof Amnon Hoffman of the Hebrew University at the 32nd annual meeting of the Controlled Release Society in Miami, Florida.
