The new excipient technology - Instanute DR – is designed to protect active pharmaceutical ingredients (APIs) from acidic conditions in the gut and is produced at Ideal’s WHO-GMP/ISO certified facility in Vasai, India.
Dario Luini area manager of Ideal Cures Europe – who launched Instanute DR at the Vitafoods tradeshow in Geneva, Switzerland earlier today – told in-Pharmatechnologist.com that the idea was to create a 'genuine' delayed-release system.
“The main difference between Instanute DR and other enteric coating systems is that it is the only one to be truly pH dependent, others based on starch or shellac simply create a physical barrier which makes release less predictable.”
He also suggested that the alginic acid-based formulation has a number of stability advantages over other delayed-release coating systems, particularly those based on the insect secretion extract shellac.
“The disintegration profiles of shellac-coated tablets change over time,” Luini said, suggesting that this could mean "drugs formulated to release their actives in 60 minutes could – after six months on the shelf – degrade and release them in 90 minutes instead."
In contrast, Instanute DR is designed to be stable batch to batch and – when used to coat tablets - can be formulated to delay the release of its contents by up to two hours.
Luini also explained that new excipient - which can be applied to any API, nutraceutical, food ingredient or dietary supplement - is the only delivery system “based on a GRAS polymer that has been accepted in EU and US.”
This was echoed by Ideal Cures managing director Suresh Pareek who told us that “It [Instanute DR] complies with all regulatory requirements in US and Europe” and said that the firm has already received interest from drugmakers in both regions.
The tech is the second delivery system Ideal has unveiled this year behind the immediate release coating system Instacoat P4, for which the firm was granted a US patent in March.