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In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria.
J Vector Borne Dis. 2008 Mar; 45(1):60-5.JV

Abstract

BACKGROUND & OBJECTIVES

The availability of numerous brands of artesunate in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of nine brands of artesunate tablets marketed in Nigeria using in vitro tests.

METHODS

The in vitro dissolution study was carried out on the nine brands of artesunate tablets using the basket method according to US Pharmacopoeia (USP) guidelines. Other general quality assessment tests like hardness and disintegration time were also determined.

RESULTS

All the brands tested passed the British Pharmacopoeia (BP) standard for disintegration time. Only AT2, AT4, AT6 and AT9 passed the standard for hardness. There were significant differences in the dissolution profiles of the nine brands. All the brands except AT1, however, released >70% of artesunate within 30 min. Four of the brands AT5, AT6, AT7 and AT8 exhibited >90% dissolution in <10 min. The other brands AT1, AT2, AT3, AT4 and AT9 (innovator brand) have calculated similarity factors of 23.8, 59.8, 50, 54.8 and 100.

INTERPRETATION & CONCLUSION

Based on the in vitro tests, AT5, AT6, AT7 and AT8 are considered bioequivalent and interchangeable, while AT2, AT3 and AT4 are considered bioequivalent and interchangeable with the innovator brand (AT9). AT1 has very low dissolution rate, which will likely result in poor bioavailability. The results show the need for constant monitoring of new brands of artesunate introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.

Authors+Show Affiliations

Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, Nigeria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18399319

Citation

Esimone, C O., et al. "In Vitro Bioequivalence Study of Nine Brands of Artesunate Tablets Marketed in Nigeria." Journal of Vector Borne Diseases, vol. 45, no. 1, 2008, pp. 60-5.
Esimone CO, Okoye FB, Onah BU, et al. In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria. J Vector Borne Dis. 2008;45(1):60-5.
Esimone, C. O., Okoye, F. B., Onah, B. U., Nworu, C. S., & Omeje, E. O. (2008). In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria. Journal of Vector Borne Diseases, 45(1), 60-5.
Esimone CO, et al. In Vitro Bioequivalence Study of Nine Brands of Artesunate Tablets Marketed in Nigeria. J Vector Borne Dis. 2008;45(1):60-5. PubMed PMID: 18399319.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria. AU - Esimone,C O, AU - Okoye,F B C, AU - Onah,B U, AU - Nworu,C S, AU - Omeje,E O, PY - 2008/4/11/pubmed PY - 2008/5/6/medline PY - 2008/4/11/entrez SP - 60 EP - 5 JF - Journal of vector borne diseases JO - J Vector Borne Dis VL - 45 IS - 1 N2 - BACKGROUND & OBJECTIVES: The availability of numerous brands of artesunate in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of nine brands of artesunate tablets marketed in Nigeria using in vitro tests. METHODS: The in vitro dissolution study was carried out on the nine brands of artesunate tablets using the basket method according to US Pharmacopoeia (USP) guidelines. Other general quality assessment tests like hardness and disintegration time were also determined. RESULTS: All the brands tested passed the British Pharmacopoeia (BP) standard for disintegration time. Only AT2, AT4, AT6 and AT9 passed the standard for hardness. There were significant differences in the dissolution profiles of the nine brands. All the brands except AT1, however, released >70% of artesunate within 30 min. Four of the brands AT5, AT6, AT7 and AT8 exhibited >90% dissolution in <10 min. The other brands AT1, AT2, AT3, AT4 and AT9 (innovator brand) have calculated similarity factors of 23.8, 59.8, 50, 54.8 and 100. INTERPRETATION & CONCLUSION: Based on the in vitro tests, AT5, AT6, AT7 and AT8 are considered bioequivalent and interchangeable, while AT2, AT3 and AT4 are considered bioequivalent and interchangeable with the innovator brand (AT9). AT1 has very low dissolution rate, which will likely result in poor bioavailability. The results show the need for constant monitoring of new brands of artesunate introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards. SN - 0972-9062 UR - https://www.unboundmedicine.com/medline/citation/18399319/In_vitro_bioequivalence_study_of_nine_brands_of_artesunate_tablets_marketed_in_Nigeria_ L2 - http://www.mrcindia.org/journal/issues/451060.pdf DB - PRIME DP - Unbound Medicine ER -