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Establishment of a reference formulation for bioequivalence assessment of rifampicin-containing FDCs: an essential step towards improving tuberculosis treatment.
Int J Tuberc Lung Dis. 2005 Jul; 9(7):791-6.IJ

Abstract

SETTING

Selection of a reference product for bioequivalence studies of rifampicin (RMP) in prequalifying fixed-dose combinations (FDC) for worldwide distribution through the WHO is critical.

OBJECTIVE

To investigate the feasibility of establishing FDC formulations as reference products for bioequivalence studies of RMP in prequalification programmes.

DESIGN

A biostudy was conducted as an open, two-period randomised cross-over trial. Two three-drug FDCs containing RMP, isoniazid and ethambutol hydrochloride were administered to a group of 22 volunteers with a wash-out period of 1 week. Plasma samples were collected and analysed for the concentration of RMP and desacetyl-RMP, a major active metabolite of RMP, up to 24 h. Pharmacokinetic parameters of RMP were calculated: Cmax, AUC0-24, Tmax, kel and absorption efficiencies.

RESULTS

No significant difference was observed between the administered formulations with respect to the major pharmacokinetic parameters Cmax, Tmax and AUC0-24 when evaluated by parametric (two-way ANOVA) and non-parametric (Hauschke's analysis) statistical analysis. The concentration of RMP falls within the reported acceptable therapeutic range.

CONCLUSION

FDCs can be developed as a reference product for bioequivalence studies.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16013776

Citation

Ashokraj, Y, et al. "Establishment of a Reference Formulation for Bioequivalence Assessment of Rifampicin-containing FDCs: an Essential Step Towards Improving Tuberculosis Treatment." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 9, no. 7, 2005, pp. 791-6.
Ashokraj Y, Singh I, Kaur KJ, et al. Establishment of a reference formulation for bioequivalence assessment of rifampicin-containing FDCs: an essential step towards improving tuberculosis treatment. Int J Tuberc Lung Dis. 2005;9(7):791-6.
Ashokraj, Y., Singh, I., Kaur, K. J., Kohli, G., Bhade, S. R., Varma, M. V., Kaul, C. L., & Panchagnula, R. (2005). Establishment of a reference formulation for bioequivalence assessment of rifampicin-containing FDCs: an essential step towards improving tuberculosis treatment. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 9(7), 791-6.
Ashokraj Y, et al. Establishment of a Reference Formulation for Bioequivalence Assessment of Rifampicin-containing FDCs: an Essential Step Towards Improving Tuberculosis Treatment. Int J Tuberc Lung Dis. 2005;9(7):791-6. PubMed PMID: 16013776.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Establishment of a reference formulation for bioequivalence assessment of rifampicin-containing FDCs: an essential step towards improving tuberculosis treatment. AU - Ashokraj,Y, AU - Singh,I, AU - Kaur,K J, AU - Kohli,G, AU - Bhade,S R, AU - Varma,M V S, AU - Kaul,C L, AU - Panchagnula,R, PY - 2005/7/15/pubmed PY - 2005/10/8/medline PY - 2005/7/15/entrez SP - 791 EP - 6 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 - 9 IS - 7 N2 - SETTING: Selection of a reference product for bioequivalence studies of rifampicin (RMP) in prequalifying fixed-dose combinations (FDC) for worldwide distribution through the WHO is critical. OBJECTIVE: To investigate the feasibility of establishing FDC formulations as reference products for bioequivalence studies of RMP in prequalification programmes. DESIGN: A biostudy was conducted as an open, two-period randomised cross-over trial. Two three-drug FDCs containing RMP, isoniazid and ethambutol hydrochloride were administered to a group of 22 volunteers with a wash-out period of 1 week. Plasma samples were collected and analysed for the concentration of RMP and desacetyl-RMP, a major active metabolite of RMP, up to 24 h. Pharmacokinetic parameters of RMP were calculated: Cmax, AUC0-24, Tmax, kel and absorption efficiencies. RESULTS: No significant difference was observed between the administered formulations with respect to the major pharmacokinetic parameters Cmax, Tmax and AUC0-24 when evaluated by parametric (two-way ANOVA) and non-parametric (Hauschke's analysis) statistical analysis. The concentration of RMP falls within the reported acceptable therapeutic range. CONCLUSION: FDCs can be developed as a reference product for bioequivalence studies. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/16013776/Establishment_of_a_reference_formulation_for_bioequivalence_assessment_of_rifampicin_containing_FDCs:_an_essential_step_towards_improving_tuberculosis_treatment_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=9&issue=7&spage=791&aulast=Ashokraj DB - PRIME DP - Unbound Medicine ER -