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Vol. 28 No. 10 (2016): Vol 28 Issue 10

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Statistical Design Based on 90 % Confidence Intervals Analysis of Bioequivalence Studies of Sustained Release Capsules of Metoprolol Tartrate on Healthy Human Volunteers

https://doi.org/10.14233/ajchem.2016.19969
D. Lateef1
1Deanery of Academic Services, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 2Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India 3Acharya & B.M. Reddy College of Pharmacy, Bangalore-560 090, India 4Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt *Corresponding authors: Tel: +966 564266609; E-mail: mohi_iqbal@yahoo.com; drsiddiquepharma@gmail.com
S. Siddique2
1Deanery of Academic Services, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 2Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India 3Acharya & B.M. Reddy College of Pharmacy, Bangalore-560 090, India 4Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt *Corresponding authors: Tel: +966 564266609; E-mail: mohi_iqbal@yahoo.com; drsiddiquepharma@gmail.com
A. Bose3
1Deanery of Academic Services, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 2Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India 3Acharya & B.M. Reddy College of Pharmacy, Bangalore-560 090, India 4Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt *Corresponding authors: Tel: +966 564266609; E-mail: mohi_iqbal@yahoo.com; drsiddiquepharma@gmail.com
M.I. Mohammed Abdul4
1Deanery of Academic Services, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 2Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India 3Acharya & B.M. Reddy College of Pharmacy, Bangalore-560 090, India 4Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt *Corresponding authors: Tel: +966 564266609; E-mail: mohi_iqbal@yahoo.com; drsiddiquepharma@gmail.com
A.M. Shehata4
1Deanery of Academic Services, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 2Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India 3Acharya & B.M. Reddy College of Pharmacy, Bangalore-560 090, India 4Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt *Corresponding authors: Tel: +966 564266609; E-mail: mohi_iqbal@yahoo.com; drsiddiquepharma@gmail.com

Asian Journal of Chemistry, Vol. 28 No. 10 (2016): Vol 28 Issue 10

Abstract

The bioequivalence study of formulations of sustained release coated granules equivalent to100 mg metoprolol tartrate (TEST-C1) with the reference formulation (Metolar XR 100SR) tablets of Cipla Ltd. was done. The study was typical two-period, randomized, two-way complete crossover design in 6 healthy, male human volunteers. There was 2 dosing sessions with a washout period of 7 days between the two sessions. Drug plasma samples were collected over a 24 h period after administration. Subsequently, plasma concentrations of drug were analyzed by using HPLC/UV. Pharmacokinetic parameters were determined by using non-compartmental analysis. The results showed that 90 % confidence intervals of the peak concentration (Cmax) and the area under the concentration-time curve (AUC) of reference and test were within the range 80-125 %. Consequently the bioequivalence of these two preparations can be concluded.

Keywords

Metoprolol tartrate Bioequivalence study Confidence intervals.
Lateef1, D., Siddique2, S., Bose3, A., Mohammed Abdul4, M., & Shehata4, A. (2017). Statistical Design Based on 90 % Confidence Intervals Analysis of Bioequivalence Studies of Sustained Release Capsules of Metoprolol Tartrate on Healthy Human Volunteers. Asian Journal of Chemistry, 28(10), 2283–2288. https://doi.org/10.14233/ajchem.2016.19969
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