Table of Contents
Advances in Pharmaceutics
Volume 2014 (2014), Article ID 304757, 12 pages
http://dx.doi.org/10.1155/2014/304757
Review Article

A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms

Sunovion Pharmaceuticals Inc, Marlborough, MA 01752, USA

Received 16 June 2014; Revised 15 August 2014; Accepted 15 August 2014; Published 20 November 2014

Academic Editor: Cornelia M. Keck

Copyright © 2014 Susan D’Souza. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straightforward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane. Novel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these methods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future efforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation development of nano-sized dosage forms.