enTRinsic™ drug delivery technology – full enteric protection / delayed release without the use of coatings.
Capsugel developed enTRinsic drug delivery technology to provide oral delivery with full enteric protection and rapid release in the upper gastrointestinal (GI) tract without the use of coatings. enTRinsic capsules are manufactured using pharmaceutical grades of cellulosic enteric derivatives (100%). This novel and proprietary technology has proven in vitro and in vivo performance, and is finding application in several areas:
- Enabling the oral delivery of sensitive molecules, such as nucleotides and peptides, vaccines and live biotherapeuticproducts (LBPs).
- A product development tool enabling rapid prototype development and accelerated in vivo testing.
- A novel enteric dosage form for market differentiation and/or intellectual property.
Sensitive Molecule Applications
Some products are difficult or impossible to deliver orally due to the need for enteric protection, but the inability to withstand either the high temperatures associated with coating application and/or sensitivity to the coating solution or suspension.
enTRinsic drug delivery technology can therefore be enabling for oral delivery, providing full enteric protection without coating, and applicable to a range of sensitive molecules:
- Live Biotherapeutic Products
enTRinsic drug delivery technology has been shown to rapidly release at pH 5.5 allowing optimal absorption in the upper GI tract.
Product Development Tool
enTRinsic drug delivery technology can be utilized to greatly simplify and accelerate prototype development and rapid in vivo testing of products requiring enteric protection and/or targeted release to the upper GI tract:
- Eliminate coating system preparation and application steps.
- Rapid screening and optimization of enteric performance.
- Remove dependency of enteric functionality with process variability.
- Obviate need for process development of the enteric coating step, process scale-up and validation.
Independent analysis estimates time savings afforded by enTRinsic drug delivery technology of 9 months or more through Phase III.