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Investigation of dissolution behavior of diclofenac sodium extended release formulations under standard and biorelevant test conditions.
Drug Dev Ind Pharm. 2010 May; 36(5):518-30.DD

Abstract

BACKGROUND

Dissolution characteristics of four extended release (ER) generic formulations of diclofenac sodium were examined.

AIM

The aim of this study was to compare the drug dissolution behavior of diclofenac ER generics to clarify whether the products are characterized by comparable dissolution characteristics under the applied test conditions.

METHODS

The investigations were performed in the USP apparatus 2 and in the new biorelevant dissolution stress test device.

RESULTS

The experiments yielded striking differences between the generic formulations. Applying USP apparatus 2 it was noticed that the dissolution profiles of the products were distinctly affected by the stirring rate. Using the biorelevant dissolution stress test device susceptibility of the products to biorelevant stresses was observed. Change of pH within the experiments reduced the dissolution rates of all formulations and distinctly influenced their dissolution characteristics.

CONCLUSION

The study demonstrates clearly the divergences in the dissolution behavior among the generic ER formulations of diclofenac sodium. The observed susceptibility of the tested dosage forms toward biorelevant stress bears in our interpretation the risk to cause unwanted fluctuations in drug plasma concentration profiles.

Authors+Show Affiliations

Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmacy, University of Greifswald, Greifswald, Germany. grzegorz.garbacz@ uni-greifswald.deNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19877827

Citation

Garbacz, Grzegorz, and Werner Weitschies. "Investigation of Dissolution Behavior of Diclofenac Sodium Extended Release Formulations Under Standard and Biorelevant Test Conditions." Drug Development and Industrial Pharmacy, vol. 36, no. 5, 2010, pp. 518-30.
Garbacz G, Weitschies W. Investigation of dissolution behavior of diclofenac sodium extended release formulations under standard and biorelevant test conditions. Drug Dev Ind Pharm. 2010;36(5):518-30.
Garbacz, G., & Weitschies, W. (2010). Investigation of dissolution behavior of diclofenac sodium extended release formulations under standard and biorelevant test conditions. Drug Development and Industrial Pharmacy, 36(5), 518-30. https://doi.org/10.3109/03639040903311081
Garbacz G, Weitschies W. Investigation of Dissolution Behavior of Diclofenac Sodium Extended Release Formulations Under Standard and Biorelevant Test Conditions. Drug Dev Ind Pharm. 2010;36(5):518-30. PubMed PMID: 19877827.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Investigation of dissolution behavior of diclofenac sodium extended release formulations under standard and biorelevant test conditions. AU - Garbacz,Grzegorz, AU - Weitschies,Werner, PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2011/1/25/medline SP - 518 EP - 30 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 36 IS - 5 N2 - BACKGROUND: Dissolution characteristics of four extended release (ER) generic formulations of diclofenac sodium were examined. AIM: The aim of this study was to compare the drug dissolution behavior of diclofenac ER generics to clarify whether the products are characterized by comparable dissolution characteristics under the applied test conditions. METHODS: The investigations were performed in the USP apparatus 2 and in the new biorelevant dissolution stress test device. RESULTS: The experiments yielded striking differences between the generic formulations. Applying USP apparatus 2 it was noticed that the dissolution profiles of the products were distinctly affected by the stirring rate. Using the biorelevant dissolution stress test device susceptibility of the products to biorelevant stresses was observed. Change of pH within the experiments reduced the dissolution rates of all formulations and distinctly influenced their dissolution characteristics. CONCLUSION: The study demonstrates clearly the divergences in the dissolution behavior among the generic ER formulations of diclofenac sodium. The observed susceptibility of the tested dosage forms toward biorelevant stress bears in our interpretation the risk to cause unwanted fluctuations in drug plasma concentration profiles. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/19877827/Investigation_of_dissolution_behavior_of_diclofenac_sodium_extended_release_formulations_under_standard_and_biorelevant_test_conditions_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639040903311081 DB - PRIME DP - Unbound Medicine ER -