Abstract

DEVELOPMENT OF IN VITRO DRUG RELEASE TEST METHODS FOR DOXORUBICIN NANO PHARMACEUTICAL WITH DIFFERENT APPROACHES

Deepak Kayande*, Shripad Deshpande, Mazahar Farooqui, Parag Deshmukh

ABSTRACT

In the past few years, measurement of drug release from pharmaceutical dosage forms has been a focus of extensive research because the release profile obtained in vitro can give an indication of the drug’s performance in vivo. Drug release behavior is an important factor related to drug stability and therapeutic results. Currently, there are no compendial in vitro release methods designed for liposomes owing to a range of experimental challenges, which has created a major hurdle for both development and regulatory acceptance of liposome-based drug products. In this paper, we develop and used the techniques to assess in vitro drug release from PEGylated doxorubicin prepared in laboratory and doxorubicin liposomal products available in market for comparative study; these include the membrane diffusion techniques, (dialysis membrane (DM)) the sample-and-separate (SS) approach, the continuous flow (CF), rotating bottle apparatus (RBA). The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straight forward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, a new method that involves the use of cation exchange resin Dowex-50 also gives the 85% drug release in 24 hours, while the SS techniques gives more than 85% release in 8 hours at 45°C. Different buffer concentrations, temperature and variation in pH of buffer show the significant changes in drug release.

Keywords: Dialysis, Release techniques, Doxorubicin liposomes, Dowex-50.