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Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet.
AAPS PharmSciTech. 2010 Sep; 11(3):1026-37.AP

Abstract

Several matrix tablet formulations (hydrophilic-based, wax-based, and three-layer tablets) were designed for controlling the release of the highly water soluble drug, venlafaxine hydrochloride (VenHCl) for once-daily administration. The three-layer tablets consist of non-swellable, compritol-based middle layers containing the drug to which hydrophilic top and bottom barrier layers were applied. A 2(3) full-factorial design was employed for optimization and to explore the effect of different variables on the release rate of the drug from the three-layer tablets. The optimized levels of each independent variable were based on the criterion of desirability. The calculated values of f(1) and f(2) were 4.131 and 79.356, respectively; indicating that the release profile of the optimized PEO layered tablet formulation is comparable to that of the target release model. The pharmacokinetic parameters of VenHCl from the optimized three-layer tablet was compared to the marketed extended release capsule as a reference in healthy human subjects using a randomized crossover design. In this study, the 90% confidence interval for AUC(0-24) and AUC(0-∞) are within (0.8-1.25), which satisfied the bioequivalence criteria. It could be concluded that a promising once-daily extended-release three-layer tablet of the highly water soluble drug, VenHCl, was successfully designed.

Authors+Show Affiliations

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, 11562, Cairo, Egypt. aaboelwafa@hotmail.comNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20532709

Citation

Aboelwafa, Ahmed A., and Emad B. Basalious. "Optimization and in Vivo Pharmacokinetic Study of a Novel Controlled Release Venlafaxine Hydrochloride Three-layer Tablet." AAPS PharmSciTech, vol. 11, no. 3, 2010, pp. 1026-37.
Aboelwafa AA, Basalious EB. Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet. AAPS PharmSciTech. 2010;11(3):1026-37.
Aboelwafa, A. A., & Basalious, E. B. (2010). Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet. AAPS PharmSciTech, 11(3), 1026-37. https://doi.org/10.1208/s12249-010-9467-z
Aboelwafa AA, Basalious EB. Optimization and in Vivo Pharmacokinetic Study of a Novel Controlled Release Venlafaxine Hydrochloride Three-layer Tablet. AAPS PharmSciTech. 2010;11(3):1026-37. PubMed PMID: 20532709.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet. AU - Aboelwafa,Ahmed A, AU - Basalious,Emad B, Y1 - 2010/06/08/ PY - 2009/11/28/received PY - 2010/05/24/accepted PY - 2010/6/10/entrez PY - 2010/6/10/pubmed PY - 2011/3/8/medline SP - 1026 EP - 37 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 11 IS - 3 N2 - Several matrix tablet formulations (hydrophilic-based, wax-based, and three-layer tablets) were designed for controlling the release of the highly water soluble drug, venlafaxine hydrochloride (VenHCl) for once-daily administration. The three-layer tablets consist of non-swellable, compritol-based middle layers containing the drug to which hydrophilic top and bottom barrier layers were applied. A 2(3) full-factorial design was employed for optimization and to explore the effect of different variables on the release rate of the drug from the three-layer tablets. The optimized levels of each independent variable were based on the criterion of desirability. The calculated values of f(1) and f(2) were 4.131 and 79.356, respectively; indicating that the release profile of the optimized PEO layered tablet formulation is comparable to that of the target release model. The pharmacokinetic parameters of VenHCl from the optimized three-layer tablet was compared to the marketed extended release capsule as a reference in healthy human subjects using a randomized crossover design. In this study, the 90% confidence interval for AUC(0-24) and AUC(0-∞) are within (0.8-1.25), which satisfied the bioequivalence criteria. It could be concluded that a promising once-daily extended-release three-layer tablet of the highly water soluble drug, VenHCl, was successfully designed. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/20532709/Optimization_and_in_vivo_pharmacokinetic_study_of_a_novel_controlled_release_venlafaxine_hydrochloride_three_layer_tablet_ L2 - https://dx.doi.org/10.1208/s12249-010-9467-z DB - PRIME DP - Unbound Medicine ER -