Scientia Pharmaceutica

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Comparative Bioavailability Study of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers


Affiliations
1 Department of Pharmaceutics, Faculty of Pharmacy, King Saud University, El Riyadh, Saudi Arabia
2 Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt

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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 B). 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.
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  • [I] Hochhaus G, Mollmann Pharmacokinetic/Pharmacodynamic Characteristics of the Beta2-agonists Terbutaline, Salbutamol and Fenoterol. Int. J. Clin. Phmaracol. Ther. Toxicol. 1992; 9:342-362.

  • Nyberg L. Pharmacokinetic Parameters of Terbutaline in Healthy Man, An overview. Europ. J. Resp. Disease. 1984; 65:149-160.

  • Sir Collin Dollery, editors. IN: Therapeutic Drugs, Volume 2, Churchill Livingstone, 1999: T45.

  • Leferink J G et al, [Pharmacokinetics of terbutaline, a β2-sympathomimetic, in healthy volunteers and asthmatic patients. Arzneim.-Forsch./Drug Res. 1982; 32: 159-164.

  • Hutching M J, Paull J Dl Morgan D J. Determination of Salbutamol in Plasma by High Performance Liquid Chromatography with Fluorescence Detection. J. Chromatogr. Biomed. Appl. 1983; 277: 423-426.

  • Shah V P, Midha K K, Dighe S, McGilveray I J, Skelly J P, Yacobi A, Layloft TI Viswanathan C T, Cook C E, McDowall R D, Pitman K A. Spector, S. Conference Report: Analytical Method Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Pharm. Res. 1992; 9: 588-592.

  • The United States Pharmacopoeia (USP) 24; The National Formulary XIX, United States Pharmacopoeial Convention, Rockville, MD, 2000; p 1607

  • Win Nonlin, Professional Edition, Version 2.1, Pharsight Corp., 800 West Elcamino Real, Suite 200, Mountain View, CA 94040.

  • Sanford Bolton, editor. In: Pharmaceutical Statistics, Practical and Clinical Applications, 2nd Ed, Revised and Expanded, Marcel Dekker, Inc. New York and Basel, 1990: 379-388.

  • FDA Guidelines, Bioequivalence Food and Drug Administration, Division of Bioequivalence, Office of Generic Drugs: Rockville, MD, 1 July 1992.


Abstract Views: 256




  • Comparative Bioavailability Study of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers

Abstract Views: 256  | 

Authors

Nahla S. Barakat
Department of Pharmaceutics, Faculty of Pharmacy, King Saud University, El Riyadh, Saudi Arabia
Nawal M. Khalafallah
Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
Said A. Khalil
Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt

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 B). 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.

References