TY  - JOUR
A1  - Taupitz, Thomas
A1  - Klein, Sandra
T1  - Can biorelevant media be simplified by using SLS and tween 80 to replace bile compounds?
T2  - The open drug delivery journal : TODDJ
N2  - In the scientific literature, the use of a surfactant is recommended for both designing quality control tests for water insoluble or sparingly water soluble drugs and for predicting the bioavailability of drugs from various types of formulations. Since the number of poorly soluble drugs is increasing, the selection of adequate dissolution test for these becomes more and more important. The aim of the present study was to develop predictive and discriminatory test methods based on surfactants that are recommended in the literature. Particular respect was given to the use of sodium lauryl sulfate and Tween 80, the two most commonly used surfactants for this purpose. Tamoxifen was used as a model drug. Dissolution experiments were performed using various concentrations of the two surfactants in buffer media typically used to prepare biorelevant test media. Results were then compared with those deriving from the same test formulations in biorelevant and simplified “biorelevant” media. Results from this study indicate that the concentration of surfactant has a huge impact on both the rate and extent of drug release from the formulation and also on the discriminatory power of the test. However, they also indicate that a well designed and validated test medium containing SLS or Tween 80 can be useful in terms of establishing a discriminatory test medium that possibly could also be used to assure batch to batch bioequivalence. Therefore, the approach described in the present paper might be very helpful for developing predictive and discriminatory methods in early formulation development for poorly soluble drugs and which could also be adopted for QC.
KW  - biorelevant media
KW  - surfactants
KW  - simplified media
KW  - dissolution
KW  - poorly soluble drugs
Y1  - 2013
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/28855
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-288557
SN  - 1874-1266
N1  - © Taupitz and Klein; Licensee Bentham Open. This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
VL  - 4
SP  - 30
EP  - 37
PB  - Bentham Open
CY  - Sharjah [u.a.]
ER  -