“Enteric-coated products are designed to remain intact in the acidic juices of the stomach and then to release the drug at the higher pH of the small intestine (above pH 5.5) or at the even higher pH in the colon (above pH 6.5): the drug
A common issue with active pharmaceutical ingredients (APIs) is their inability to withstand the harsh environment of the stomach acids. Enteric coating saves the API from being harmed by the gastric environment. This paramount step in creating a viable final product often takes multiple steps to achieve.
Two common enteric coating techniques are powder layering and suspension layering. Both of these techniques rely on creating multiple layers of enteric excipient over the API. These techniques require multiple coatings and can also result in uneven layers and incomplete coverage of the API. This often laborious process adds additional cost to the manufacturing process.
In contrast to these techniques, Orbis Biosciences creates drug product and drug product intermediate with
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