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Sci. Pharm.
Volume 72
Issue 3
10.3797/scipharm.aut-04-19
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Article

Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers

by
Nahla S. Barakat
1,*,
Nawal M. Khalafallah
2 and
Said A. Khalil
2
1
Department of Pharmaceutics, Faculty of Pharmacy, King Saud University, El Riyadh, Saudi Arabia
2
Departmenotf Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2004, 72(3), 227-237; https://doi.org/10.3797/scipharm.aut-04-19
Submission received: 19 April 2004 / Revised: 1 September 2004 / Accepted: 1 September 2004 / Published: 7 September 2004
Versions Notes

Abstract

The purpose of this study was to evaluate the bioavailability of locally produced 2.5 mg terbutaline sulphate tablets (brand A ) relative to a reference product, Bricanyl 2.5 mg tablets (brand 6). The study was a single dose 5 mg randomized crossover one in 15 healthy volunteers in the fasting state. Urine was collected at intervals of 24 h. Total terbutaline excreted in urine as unchanged drug and as conjugates (sulphate and glucuronide) was determined by a developed and validated HPLC method. In-vitro characteristics of both brands were similar. Based on percent of the dose excreted in urine, the oral bioavailability ranged from 33.5% to 75.8% for both brands. Statistics were applied to judge bioequivalence according to USP 24 in-vivo bioequivalence guidance. Results indicated that brand A and B were bioequivalent and hence interchangeable in medical practice.
Keywords: Terbutaline sulphate; Tablet; Bioequivalence; Urine; HPLC analysis Terbutaline sulphate; Tablet; Bioequivalence; Urine; HPLC analysis

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MDPI and ACS Style

Barakat, N.S.; Khalafallah, N.M.; Khalil, S.A. Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers. Sci. Pharm. 2004, 72, 227-237. https://doi.org/10.3797/scipharm.aut-04-19

AMA Style

Barakat NS, Khalafallah NM, Khalil SA. Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers. Scientia Pharmaceutica. 2004; 72(3):227-237. https://doi.org/10.3797/scipharm.aut-04-19

Chicago/Turabian Style

Barakat, Nahla S., Nawal M. Khalafallah, and Said A. Khalil. 2004. "Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers" Scientia Pharmaceutica 72, no. 3: 227-237. https://doi.org/10.3797/scipharm.aut-04-19

APA Style

Barakat, N. S., Khalafallah, N. M., & Khalil, S. A. (2004). Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers. Scientia Pharmaceutica, 72(3), 227-237. https://doi.org/10.3797/scipharm.aut-04-19

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