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DuoCoat

Improve Efficacy with Targeted Rapid Drug Release

Enabling rapid drug release in the upper small intestine or colon

DuoCoat® is an advanced oral drug delivery technology designed to achieve enteric protection and rapid drug release in the upper small intestine or ileocolonic region to improve the efficacy of your oral solid dosage forms. It is ideal for use with API classes such as protein pump inhibitors, NSAIDs, corticosteroids and glycosides. The proprietary, dual-layer technology can also improve the bioavailability of drugs with narrow absorption windows in the small intestine. Clinically proven for rapid drug release, DuoCoat® is applicable to a range of dosage forms including tablets, capsules and pellets, and is suitable for use with standard manufacturing equipment.

A superior gastro-resistant coating for rapid drug release

DuoCoat® is a novel dual-action technology for rapid drug release that is designed for use with various drugs and dosage forms including monolithics and multiparticulates. It consists of an enteric outer layer of an enteric EUDRAGIT® polymer, and an inner layer of partially neutralised enteric polymer and a buffer agent. The buffer capacity of the neutralized inner layer and thus the rate of rapid drug release can be further optimized through the addition of organic acids. Depending on the type of EUDRAGIT® enteric polymer used, DuoCoat® can be customized to enable rapid drug release in specific regions of either the upper small intestine or distally in the ileo-colonic region. In addition to enabling rapid drug release at a precise location, it is designed to minimize exposure to efflux transporters and gut microbiota.

A clinically-proven mechanism of action for rapid drug release

After passing through the stomach intact, Duocoat® begins to encounter gastrointestinal fluid as the environmental pH value increases. At pH 5.5, the outer EUDRAGIT® coating begins to swell and dissolve, allowing intestinal fluid to penetrate into the system and reach the neutralized inner coating layer. The inner layer then rapidly dissolves to enable rapid drug release. The accelerated drug release of radio-labelled prednisolone DuoCoat® tablets in comparison with the standard enteric-coated tablets was proven in vitro in bio-relevant media which followed a two-hour incubation period in an acidic medium. The almost three times faster disintegration time and reduced inter- and intra-subject variability in results has been confirmed in in vivo studies with human subjects. On average, Duocoat® tablets disintegrated after 20 to 35 minutes in the proximal small intestine, and thus enabled significantly faster drug release compared to conventional enteric tablets.

Beyond rapid drug release, DuoCoat® provides a range of formulation and application options

DuoCoat®, which was developed in collaboration with the University College London, enables rapid release with the use of conventional manufacturing equipment and processes. Application opportunities include enabling the rapid onset of the target action in the small intestine, enhancing the bioavailability of drugs with narrow absorption windows in the small intestine, and improve the targeting of drugs in the ileo-colonic region. Being patent protected, it also provides a range of attractive options for product differentiation and lifecycle management of drug products supplied in an oral solid dosage form.

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DuoCoat

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