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Bioavailability modified-release dosage forms

One major roadblock in the delivery of insulin via the oral cavity is the need for the drug to pass through the acidic environment of the stomach and the presence of peptidases in the stomach and the small intestines, resulting in the inactivation of the drug. Various processes have been generated to improve on the oral bioavailability of the protein. Insulin can be encapsulated in time-released dosage forms or micellar formulations, attached to bile acids, modified with amphiphilic polymers, or coadministered with delivery agents. [Pg.316]

EU CPMP (1999) Note for Guidance on Modified Release Oral and Transdermal Dosage Forms Section II (Pharmacokinetic and Clinical Evaluation) July 1999 EU CPMP (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence. July 2001 ICH-E5 (1998) Ethnic Factors in the Acceptability of Foreign Clinical Data. March 1998... [Pg.662]


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Bioavailability dosage forms

Modified-release dosage forms

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