Contribution information

Title Development and Optimization of Dissolution Test for Long-Acting Injectable Prodrug Suspension
Status Not decided yet
Type Lecture
Session Reaction engineering and catalysis
Authors E., Sonntag1, F., Štěpánek2
1 Department of Chemical Engineering, UCT Prague, Praha, Czechia
2 University of Chemistry and Technology Prague, Prague, Czechia
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Brief content This work deals with the development, optimization and validation of in vitro biorelevant dissolution test for long-acting injectable prodrug suspension. This test is part of generic drug development and is used to compare the dissolution kinetics of a generic drug with reference listed drug. Since conventional dissolution tests are not suitable for the particular formulation, it was necessary to develop a biorelevant test that reflects not only the dissolution kinetics but also the kinetics of the subsequent conversion of the prodrug to the parent drug. For this purpose, the dissolution apparatus was designed, the HPLC method was created and validated, and the kinetics of the prodrug dissolution with subsequent conversion was measured.
ID 263