The use of Organic Solvents in performing the release studies for Hydrophobic drugs is commonly seen. The main aim of the study is to see the release pattern of the drug from the formulation and to have some correlation with its in-vivo behaviour.
Most of the time we see similar methods used in publications for performing the release studies, irrespective of the type of formulation and route of administration, which is not convincing.
I would also like to know how we can design release studies in such a way that it mimics the in-vivo conditions.
Finally, can we justify the use of organic solvents and surfactants for in-vitro release studies and correlate with in-vivo behaviour?
No use of organic solvent for drug release cannot be justified for in vitro study and it's correlation with in vivo study
For the case of hydrophobic drugs (e.g. Paclitaxel) as their solubility in PBS is too low, organic solvents such as ethanol, Kolliphor (polyethoxylated castor oil), or Cremophor EL (nonionic surfactant) are used for the intravenous infusion. However, I think it depends on the administration rout, and when the use of organic solvent is inevitable we can use a biocompatible FDA approved organic solvent. For more information I suggest looking at USP and Q3C tables.
In dissolution study, they are use for maintenance of sink condition.
Similar justification was given in below article. They given good justification for Polymeric and Lipidic microparticulate systems.
Title: Accelerated in vitro release testing methods for extended release parenteral dosage forms
link of article.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3408959/#R80
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