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The potential use of urinary excretion data for assessing the relative bioavailability of rifampicin in fixed dose combination anti-tuberculosis formulations.
Int J Tuberc Lung Dis. 2001 Aug; 5(8):691-5.IJ

Abstract

SETTING

The perceived need for simple, non-invasive methods of assessing the relative bioavailability of rifampicin in fixed-dose combination (FDC) anti-tuberculosis formulations.

OBJECTIVE

To compare the performance of methods based on urinary excretion data with those utilising plasma concentration-time profiles to assess the relative bioavailability of rifampicin in combined and single-drug formulations.

DESIGN

A two-period randomised crossover bioequivalence study in healthy male volunteers with a 1 week washout period between treatments. Plasma rifampicin concentrations were measured at 0, 1, 2, 4, 6 and 8 hours after each drug administration using a high performance liquid chromatography (HPLC) method. The rifampicin and desacetylrifampicin content of complete urinary collections made from 0-4 and 4-8 hours after dosage were determined using both the HPLC and a much simpler colorimetric procedure.

RESULTS

There was good agreement between the relative bioavailability of the formulations using plasma and urinary excretion data, although the precision of the urinary-based estimates was slightly less than those derived from the plasma findings. There was also good agreement between the HPLC and colorimetric estimates of the combined urinary excretion of rifampicin plus desacetylrifampicin.

CONCLUSIONS

Urinary excretion data may be used for ongoing quality control to confirm that commercial combined rifampicin-containing formulations that were initially shown to be satisfactory continue to be so.

Authors+Show Affiliations

Department of Pharmacology, University of Durban Westville, South Africa. cpillai@pixie.udw.ac.zaNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11495257

Citation

Pillai, G, et al. "The Potential Use of Urinary Excretion Data for Assessing the Relative Bioavailability of Rifampicin in Fixed Dose Combination Anti-tuberculosis Formulations." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 5, no. 8, 2001, pp. 691-5.
Pillai G, Ellard GA, Smith PJ, et al. The potential use of urinary excretion data for assessing the relative bioavailability of rifampicin in fixed dose combination anti-tuberculosis formulations. Int J Tuberc Lung Dis. 2001;5(8):691-5.
Pillai, G., Ellard, G. A., Smith, P. J., & Fourie, P. B. (2001). The potential use of urinary excretion data for assessing the relative bioavailability of rifampicin in fixed dose combination anti-tuberculosis formulations. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 5(8), 691-5.
Pillai G, et al. The Potential Use of Urinary Excretion Data for Assessing the Relative Bioavailability of Rifampicin in Fixed Dose Combination Anti-tuberculosis Formulations. Int J Tuberc Lung Dis. 2001;5(8):691-5. PubMed PMID: 11495257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The potential use of urinary excretion data for assessing the relative bioavailability of rifampicin in fixed dose combination anti-tuberculosis formulations. AU - Pillai,G, AU - Ellard,G A, AU - Smith,P J, AU - Fourie,P B, PY - 2001/8/10/pubmed PY - 2002/1/5/medline PY - 2001/8/10/entrez SP - 691 EP - 5 JF - The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease JO - Int. J. Tuberc. Lung Dis. VL - 5 IS - 8 N2 - SETTING: The perceived need for simple, non-invasive methods of assessing the relative bioavailability of rifampicin in fixed-dose combination (FDC) anti-tuberculosis formulations. OBJECTIVE: To compare the performance of methods based on urinary excretion data with those utilising plasma concentration-time profiles to assess the relative bioavailability of rifampicin in combined and single-drug formulations. DESIGN: A two-period randomised crossover bioequivalence study in healthy male volunteers with a 1 week washout period between treatments. Plasma rifampicin concentrations were measured at 0, 1, 2, 4, 6 and 8 hours after each drug administration using a high performance liquid chromatography (HPLC) method. The rifampicin and desacetylrifampicin content of complete urinary collections made from 0-4 and 4-8 hours after dosage were determined using both the HPLC and a much simpler colorimetric procedure. RESULTS: There was good agreement between the relative bioavailability of the formulations using plasma and urinary excretion data, although the precision of the urinary-based estimates was slightly less than those derived from the plasma findings. There was also good agreement between the HPLC and colorimetric estimates of the combined urinary excretion of rifampicin plus desacetylrifampicin. CONCLUSIONS: Urinary excretion data may be used for ongoing quality control to confirm that commercial combined rifampicin-containing formulations that were initially shown to be satisfactory continue to be so. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/11495257/The_potential_use_of_urinary_excretion_data_for_assessing_the_relative_bioavailability_of_rifampicin_in_fixed_dose_combination_anti_tuberculosis_formulations_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=5&issue=8&spage=691&aulast=Pillai DB - PRIME DP - Unbound Medicine ER -