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Comparative in vitro dissolution and in vivo bioequivalence of two diclofenac enteric coated formulations.
Arzneimittelforschung. 2011; 61(10):566-70.A

Abstract

The aim of this study was the comparison of in vitro dissolution and in vivo bioavailability of two different brands of diclofenac sodium (CAS 15307-86-5) enteric coated tablets in healthy male Iranian volunteers in a single-dose, randomized, open-label, single blind study, which was conducted according to a crossover design in healthy volunteers. A washout interval of two weeks was selected between administrations to each subject in this study. Serial venous blood samples over 10 h after each administration to measure diclofenac sodium concentration in serum were obtained, and placed into tubes containing sodium heparin. Then the plasma was separated and kept frozen at -20 degrees C for subsequent analysis with a modified HPLC method with UV detection. In addition, the in vitro dissolution study was performed on the brands. For the test and reference formulation, mean Cmax values were 2257.3 (ng/ml) and 2156 (ng/ml), respectively. The mean AUC(0)tau and AUC(0)infinity were 5726.1 (ng x h/ml) and 5917.8 (ng x h/ml) for the test and 5689.9 (ng x h/ml) and 5967.4 (ng x h/ml) for the reference formulation, respectively. Results show that the 90% confidence intervals for the ratio of test and reference products in Cmax (101.4-114.9%), AUC(0)tau (96.3-109.1%) and AUC(0)infinity (94.7-107.3%) were all within the 80-125% interval proposed by the FDA and EMA. Both formulations released > 80% of drug within 30 min in buffer pH = 6.8 medium. Therefore the diclofenac sodium enteric coated tablets of the test and reference formulations are bioequivalent in terms of rate and extent of absorption.

Authors+Show Affiliations

Daana Pharmaceutical Company, Tabriz, Iran.No affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22164964

Citation

Basmenji, Saeed, et al. "Comparative in Vitro Dissolution and in Vivo Bioequivalence of Two Diclofenac Enteric Coated Formulations." Arzneimittel-Forschung, vol. 61, no. 10, 2011, pp. 566-70.
Basmenji S, Valizadeh H, Zakeri-Milani P. Comparative in vitro dissolution and in vivo bioequivalence of two diclofenac enteric coated formulations. Arzneimittelforschung. 2011;61(10):566-70.
Basmenji, S., Valizadeh, H., & Zakeri-Milani, P. (2011). Comparative in vitro dissolution and in vivo bioequivalence of two diclofenac enteric coated formulations. Arzneimittel-Forschung, 61(10), 566-70. https://doi.org/10.1055/s-0031-1300554
Basmenji S, Valizadeh H, Zakeri-Milani P. Comparative in Vitro Dissolution and in Vivo Bioequivalence of Two Diclofenac Enteric Coated Formulations. Arzneimittelforschung. 2011;61(10):566-70. PubMed PMID: 22164964.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative in vitro dissolution and in vivo bioequivalence of two diclofenac enteric coated formulations. AU - Basmenji,Saeed, AU - Valizadeh,Hadi, AU - Zakeri-Milani,Parvin, PY - 2011/12/15/entrez PY - 2011/12/15/pubmed PY - 2012/1/10/medline SP - 566 EP - 70 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 61 IS - 10 N2 - The aim of this study was the comparison of in vitro dissolution and in vivo bioavailability of two different brands of diclofenac sodium (CAS 15307-86-5) enteric coated tablets in healthy male Iranian volunteers in a single-dose, randomized, open-label, single blind study, which was conducted according to a crossover design in healthy volunteers. A washout interval of two weeks was selected between administrations to each subject in this study. Serial venous blood samples over 10 h after each administration to measure diclofenac sodium concentration in serum were obtained, and placed into tubes containing sodium heparin. Then the plasma was separated and kept frozen at -20 degrees C for subsequent analysis with a modified HPLC method with UV detection. In addition, the in vitro dissolution study was performed on the brands. For the test and reference formulation, mean Cmax values were 2257.3 (ng/ml) and 2156 (ng/ml), respectively. The mean AUC(0)tau and AUC(0)infinity were 5726.1 (ng x h/ml) and 5917.8 (ng x h/ml) for the test and 5689.9 (ng x h/ml) and 5967.4 (ng x h/ml) for the reference formulation, respectively. Results show that the 90% confidence intervals for the ratio of test and reference products in Cmax (101.4-114.9%), AUC(0)tau (96.3-109.1%) and AUC(0)infinity (94.7-107.3%) were all within the 80-125% interval proposed by the FDA and EMA. Both formulations released > 80% of drug within 30 min in buffer pH = 6.8 medium. Therefore the diclofenac sodium enteric coated tablets of the test and reference formulations are bioequivalent in terms of rate and extent of absorption. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/22164964/Comparative_in_vitro_dissolution_and_in_vivo_bioequivalence_of_two_diclofenac_enteric_coated_formulations_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1300554 DB - PRIME DP - Unbound Medicine ER -