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In-vitro simulation of luminal conditions for evaluation of performance of oral drug products: Choosing the appropriate test media.
Eur J Pharm Biopharm. 2015 Jun; 93:173-82.EJ

Abstract

BACKGROUND

Biorelevant media for evaluation of dosage form performance in the gastrointestinal lumen were first introduced in the late 1990s. Since then, a variety of additional media have been proposed, making it now possible to simulate most regions in the gastrointestinal tract in both prandial states. However, recent work suggests that the complexity and degree of biorelevance required to predict in-vivo release varies with the drug, dosage form and dosing conditions.

OBJECTIVE

The aim of this commentary was to establish which levels of biorelevant media are appropriate to various combinations of active pharmaceutical ingredient(s), dosage form and dosing conditions. With regard to their application, a decision tree for the selection of the appropriate biorelevant medium/media is proposed and illustrative case scenarios are provided. Additionally, media to represent the distal small intestine in both prandial states are presented.

CONCLUSION

The newly proposed levels of biorelevance and accompanying decision tree may serve as a useful tool during formulation development in order to ensure high quality, predictive performance results without unnecessary complexity of media. In future work, further specific case examples will be evolved, which will additionally address the need to take gastrointestinal passage times and type and intensity of agitation into consideration.

Authors+Show Affiliations

Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece.Department of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany.Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece.Department of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany.Faculty of Pharmacy, National and Kapodistrian University of Athens, Greece. Electronic address: reppas@pharm.uoa.gr.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

25836053

Citation

Markopoulos, Constantinos, et al. "In-vitro Simulation of Luminal Conditions for Evaluation of Performance of Oral Drug Products: Choosing the Appropriate Test Media." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 93, 2015, pp. 173-82.
Markopoulos C, Andreas CJ, Vertzoni M, et al. In-vitro simulation of luminal conditions for evaluation of performance of oral drug products: Choosing the appropriate test media. Eur J Pharm Biopharm. 2015;93:173-82.
Markopoulos, C., Andreas, C. J., Vertzoni, M., Dressman, J., & Reppas, C. (2015). In-vitro simulation of luminal conditions for evaluation of performance of oral drug products: Choosing the appropriate test media. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 93, 173-82. https://doi.org/10.1016/j.ejpb.2015.03.009
Markopoulos C, et al. In-vitro Simulation of Luminal Conditions for Evaluation of Performance of Oral Drug Products: Choosing the Appropriate Test Media. Eur J Pharm Biopharm. 2015;93:173-82. PubMed PMID: 25836053.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In-vitro simulation of luminal conditions for evaluation of performance of oral drug products: Choosing the appropriate test media. AU - Markopoulos,Constantinos, AU - Andreas,Cord J, AU - Vertzoni,Maria, AU - Dressman,Jennifer, AU - Reppas,Christos, Y1 - 2015/03/30/ PY - 2015/01/02/received PY - 2015/03/03/revised PY - 2015/03/05/accepted PY - 2015/4/4/entrez PY - 2015/4/4/pubmed PY - 2016/2/24/medline KW - Biorelevant media KW - Classification KW - DCS classes KW - Decision tree KW - Fasted state KW - Fed state SP - 173 EP - 82 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 93 N2 - BACKGROUND: Biorelevant media for evaluation of dosage form performance in the gastrointestinal lumen were first introduced in the late 1990s. Since then, a variety of additional media have been proposed, making it now possible to simulate most regions in the gastrointestinal tract in both prandial states. However, recent work suggests that the complexity and degree of biorelevance required to predict in-vivo release varies with the drug, dosage form and dosing conditions. OBJECTIVE: The aim of this commentary was to establish which levels of biorelevant media are appropriate to various combinations of active pharmaceutical ingredient(s), dosage form and dosing conditions. With regard to their application, a decision tree for the selection of the appropriate biorelevant medium/media is proposed and illustrative case scenarios are provided. Additionally, media to represent the distal small intestine in both prandial states are presented. CONCLUSION: The newly proposed levels of biorelevance and accompanying decision tree may serve as a useful tool during formulation development in order to ensure high quality, predictive performance results without unnecessary complexity of media. In future work, further specific case examples will be evolved, which will additionally address the need to take gastrointestinal passage times and type and intensity of agitation into consideration. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/25836053/In_vitro_simulation_of_luminal_conditions_for_evaluation_of_performance_of_oral_drug_products:_Choosing_the_appropriate_test_media_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(15)00140-X DB - PRIME DP - Unbound Medicine ER -