Article history: A novel two-stage reverse dialysis method has been developed for in vitro release testing of liposomal Received 29 November 2011 drug product with passive targeting characteristics. The ﬁrst stage of the test is to mimic the circulation Received in revised form 11 January 2012 of liposomes in the body, whereas the second stage is to imitate the drug release process at the target. Accepted 13 January 2012 Buffer and surfactant solution were used during the ﬁrst and second stages, respectively. For formula- Available online 23 January 2012 tions containing high phase transition temperature lipids and high cholesterol content, no drug leakage was observed during the ﬁrst stage of test. In the second stage, however, formulations with different Keywords: compositions showed signiﬁcant differences in terms of drug release rate, and discriminatory ability of Liposome the method was demonstrated. On comparing two different membrane diffusion techniques, dialysis and In vitro release reverse dialysis methods, the reverse dialysis method showed signiﬁcantly lower variation, and there- Tenofovir fore is the preferred method. The developed in vitro release testing method should help to distinguish Dialysis Reverse dialysis formulations with varied compositions for quality control testing purposes. This two-stage reverse dial- Membrane diffusion
International Journal of Pharmaceutics – Elsevier
Published: Apr 15, 2012
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