Tags

Type your tag names separated by a space and hit enter

In-vitro and in-vivo correlation for two gliclazide extended-release tablets.
J Pharm Pharmacol. 2007 Jul; 59(7):971-6.JP

Abstract

The aim of this study was to perform an in-vitro-in-vivo correlation (IVIVC) for two 60-mg gliclazide extended-release formulations (Fast and Slow release) given once a day and to compare their plasma concentrations over time. In-vitro release rate data were obtained for each formulation using the USP apparatus II, paddle stirrer at 50 and 100 rev min(-1) in 0.1 M HCl and pH 7.4 phosphate buffer. The similarity factor (f2) was used to analyse the dissolution data. Eighteen healthy subjects participated in the study, conducted according to a completely randomized, two-way crossover design. The formulations were compared using area under the plasma concentration-time curve, AUC(0-infinity), time to reach peak plasma concentration, Tmax, and peak plasma concentration Cmax, while correlation was determined between in-vitro release and in-vivo absorption. A linear correlation model was developed using percent absorbed data versus percent dissolved data from the two formulations. Predicted gliclazide concentrations were obtained by use of a curve fitting equation. Prediction errors were estimated for Cmax and area under the curve AUC(0-infinity) to determine the validity of the correlation. 0.1 M HCl at 50 rev min(-1) was found to be the most discriminating dissolution method. Linear regression analysis of the mean percentage of dose absorbed versus the mean percentage of in-vitro release resulted in a significant correlation (r2 > 0.98) for the two formulations. An average percent prediction error for Cmax was 4.15% for Fast release and 3.99% for Slow release formulation whereas for AUC(0-infinity) it was 6.36% and 4.66% for Fast release and Slow release formulation, respectively.

Authors+Show Affiliations

Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, S. C. Mallick Road, Kolkata, West Bengal, 700 032, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17637192

Citation

Mandal, U, et al. "In-vitro and In-vivo Correlation for Two Gliclazide Extended-release Tablets." The Journal of Pharmacy and Pharmacology, vol. 59, no. 7, 2007, pp. 971-6.
Mandal U, Ray KK, Gowda V, et al. In-vitro and in-vivo correlation for two gliclazide extended-release tablets. J Pharm Pharmacol. 2007;59(7):971-6.
Mandal, U., Ray, K. K., Gowda, V., Ghosh, A., & Pal, T. K. (2007). In-vitro and in-vivo correlation for two gliclazide extended-release tablets. The Journal of Pharmacy and Pharmacology, 59(7), 971-6.
Mandal U, et al. In-vitro and In-vivo Correlation for Two Gliclazide Extended-release Tablets. J Pharm Pharmacol. 2007;59(7):971-6. PubMed PMID: 17637192.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In-vitro and in-vivo correlation for two gliclazide extended-release tablets. AU - Mandal,U, AU - Ray,K K, AU - Gowda,Veeran, AU - Ghosh,A, AU - Pal,T K, PY - 2007/7/20/pubmed PY - 2007/10/12/medline PY - 2007/7/20/entrez SP - 971 EP - 6 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 59 IS - 7 N2 - The aim of this study was to perform an in-vitro-in-vivo correlation (IVIVC) for two 60-mg gliclazide extended-release formulations (Fast and Slow release) given once a day and to compare their plasma concentrations over time. In-vitro release rate data were obtained for each formulation using the USP apparatus II, paddle stirrer at 50 and 100 rev min(-1) in 0.1 M HCl and pH 7.4 phosphate buffer. The similarity factor (f2) was used to analyse the dissolution data. Eighteen healthy subjects participated in the study, conducted according to a completely randomized, two-way crossover design. The formulations were compared using area under the plasma concentration-time curve, AUC(0-infinity), time to reach peak plasma concentration, Tmax, and peak plasma concentration Cmax, while correlation was determined between in-vitro release and in-vivo absorption. A linear correlation model was developed using percent absorbed data versus percent dissolved data from the two formulations. Predicted gliclazide concentrations were obtained by use of a curve fitting equation. Prediction errors were estimated for Cmax and area under the curve AUC(0-infinity) to determine the validity of the correlation. 0.1 M HCl at 50 rev min(-1) was found to be the most discriminating dissolution method. Linear regression analysis of the mean percentage of dose absorbed versus the mean percentage of in-vitro release resulted in a significant correlation (r2 > 0.98) for the two formulations. An average percent prediction error for Cmax was 4.15% for Fast release and 3.99% for Slow release formulation whereas for AUC(0-infinity) it was 6.36% and 4.66% for Fast release and Slow release formulation, respectively. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/17637192/In_vitro_and_in_vivo_correlation_for_two_gliclazide_extended_release_tablets_ L2 - https://doi.org/10.1211/jpp.59.7.0009 DB - PRIME DP - Unbound Medicine ER -