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Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form.
Pharmazie 2001; 56(8):636-9P

Abstract

To increase the patient compliance and reduce the risk of drug resistant strains, WHO and IUATLD recommend the use of Fixed Dose Combination (FDC) tablets as a routine therapeutic regimen in Directly Observed Treatment Shortcourse (DOTS). But the main issue in the use of FDC is the quality of the formulation. At present WHO and IUATLD suggest the bioequivalence assessment of only rifampicin from FDC compared to separate formulations. For the therapeutic effectiveness all the components of the FDCs should be bioavailable at tissue site. Also, the primary and acquired resistance rate of isoniazid is much higher compared to other anti-tubercular drugs. Hence, a comparative bioavailability study of isoniazid from a two drugs FDC compared to a separate formulation was carried out on a group of 12 healthy volunteers. When evaluated by normal or log transformed confidence interval, Two Way ANOVA and Hauschke analysis, the bioequivalence limits for AUC0-8 and AUC0-24 were within 0.8-1.25. For Cmax and Tmax, these limits were within 0.7-1.43. Hence, isoniazid from a FDC formulation was found to be bioequivalent to a separate formulation at same dose levels.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

11534341

Citation

Agrawal, S, et al. "Bioequivalence of Isoniazid in a Two Drug Fixed Dose Combination and in a Single Drug Dosage Form." Die Pharmazie, vol. 56, no. 8, 2001, pp. 636-9.
Agrawal S, Kaul CL, Panchagnula R. Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form. Pharmazie. 2001;56(8):636-9.
Agrawal, S., Kaul, C. L., & Panchagnula, R. (2001). Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form. Die Pharmazie, 56(8), pp. 636-9.
Agrawal S, Kaul CL, Panchagnula R. Bioequivalence of Isoniazid in a Two Drug Fixed Dose Combination and in a Single Drug Dosage Form. Pharmazie. 2001;56(8):636-9. PubMed PMID: 11534341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form. AU - Agrawal,S, AU - Kaul,C L, AU - Panchagnula,R, PY - 2001/9/6/pubmed PY - 2001/10/5/medline PY - 2001/9/6/entrez SP - 636 EP - 9 JF - Die Pharmazie JO - Pharmazie VL - 56 IS - 8 N2 - To increase the patient compliance and reduce the risk of drug resistant strains, WHO and IUATLD recommend the use of Fixed Dose Combination (FDC) tablets as a routine therapeutic regimen in Directly Observed Treatment Shortcourse (DOTS). But the main issue in the use of FDC is the quality of the formulation. At present WHO and IUATLD suggest the bioequivalence assessment of only rifampicin from FDC compared to separate formulations. For the therapeutic effectiveness all the components of the FDCs should be bioavailable at tissue site. Also, the primary and acquired resistance rate of isoniazid is much higher compared to other anti-tubercular drugs. Hence, a comparative bioavailability study of isoniazid from a two drugs FDC compared to a separate formulation was carried out on a group of 12 healthy volunteers. When evaluated by normal or log transformed confidence interval, Two Way ANOVA and Hauschke analysis, the bioequivalence limits for AUC0-8 and AUC0-24 were within 0.8-1.25. For Cmax and Tmax, these limits were within 0.7-1.43. Hence, isoniazid from a FDC formulation was found to be bioequivalent to a separate formulation at same dose levels. SN - 0031-7144 UR - https://www.unboundmedicine.com/medline/citation/11534341/Bioequivalence_of_isoniazid_in_a_two_drug_fixed_dose_combination_and_in_a_single_drug_dosage_form_ DB - PRIME DP - Unbound Medicine ER -