Cargando…

Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya

Clarithromycin is a broad-spectrum semi-synthetic macrolide indicated for treatment of pneumonias, Helicobacter pylori, and chlamydial and skin infections. The object of this study was to evaluate the pharmaceutical equivalence of 14 generic clarithromycin products marketed in Nairobi County, Kenya,...

Descripción completa

Detalles Bibliográficos
Autores principales: Manani, Rebecca O., Abuga, Kennedy O., Chepkwony, Hezekiah K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489924/
https://www.ncbi.nlm.nih.gov/pubmed/28445444
http://dx.doi.org/10.3390/scipharm85020020
_version_ 1783246880322355200
author Manani, Rebecca O.
Abuga, Kennedy O.
Chepkwony, Hezekiah K.
author_facet Manani, Rebecca O.
Abuga, Kennedy O.
Chepkwony, Hezekiah K.
author_sort Manani, Rebecca O.
collection PubMed
description Clarithromycin is a broad-spectrum semi-synthetic macrolide indicated for treatment of pneumonias, Helicobacter pylori, and chlamydial and skin infections. The object of this study was to evaluate the pharmaceutical equivalence of 14 generic clarithromycin products marketed in Nairobi County, Kenya, to the innovator products, using in vitro dissolution profiles and similarity factors (f(2)). Further, dissolution profiles of four innovator formulations manufactured in different sites were compared. Fourteen clarithromycin tablets/capsules and four suspensions were subjected to assay and comparative dissolution runs at pH 1.2, 4.5 and 6.8, for 60 and 90 min, respectively. All products complied with pharmacopoeial assay specifications. However, significant differences were observed in their dissolution profiles. The non-compliance rates for tablets/capsules were 50% at pH 1.2, 33% at pH 4.5 and 50% at pH 6.8, while none of the four suspensions were compliant. Overall, only four (25%) products complied with the specifications for similarity factor. The results obtained indicate that a significant percentage of generic clarithromycin products are pharmaceutically non-equivalent to the innovator products, and that assay and single-point dissolution tests are insufficient demonstration of equivalence between the generic and innovator products.
format Online
Article
Text
id pubmed-5489924
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-54899242017-07-05 Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya Manani, Rebecca O. Abuga, Kennedy O. Chepkwony, Hezekiah K. Sci Pharm Article Clarithromycin is a broad-spectrum semi-synthetic macrolide indicated for treatment of pneumonias, Helicobacter pylori, and chlamydial and skin infections. The object of this study was to evaluate the pharmaceutical equivalence of 14 generic clarithromycin products marketed in Nairobi County, Kenya, to the innovator products, using in vitro dissolution profiles and similarity factors (f(2)). Further, dissolution profiles of four innovator formulations manufactured in different sites were compared. Fourteen clarithromycin tablets/capsules and four suspensions were subjected to assay and comparative dissolution runs at pH 1.2, 4.5 and 6.8, for 60 and 90 min, respectively. All products complied with pharmacopoeial assay specifications. However, significant differences were observed in their dissolution profiles. The non-compliance rates for tablets/capsules were 50% at pH 1.2, 33% at pH 4.5 and 50% at pH 6.8, while none of the four suspensions were compliant. Overall, only four (25%) products complied with the specifications for similarity factor. The results obtained indicate that a significant percentage of generic clarithromycin products are pharmaceutically non-equivalent to the innovator products, and that assay and single-point dissolution tests are insufficient demonstration of equivalence between the generic and innovator products. MDPI 2017-04-25 2017 /pmc/articles/PMC5489924/ /pubmed/28445444 http://dx.doi.org/10.3390/scipharm85020020 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Manani, Rebecca O.
Abuga, Kennedy O.
Chepkwony, Hezekiah K.
Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title_full Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title_fullStr Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title_full_unstemmed Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title_short Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
title_sort pharmaceutical equivalence of clarithromycin oral dosage forms marketed in nairobi county, kenya
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489924/
https://www.ncbi.nlm.nih.gov/pubmed/28445444
http://dx.doi.org/10.3390/scipharm85020020
work_keys_str_mv AT mananirebeccao pharmaceuticalequivalenceofclarithromycinoraldosageformsmarketedinnairobicountykenya
AT abugakennedyo pharmaceuticalequivalenceofclarithromycinoraldosageformsmarketedinnairobicountykenya
AT chepkwonyhezekiahk pharmaceuticalequivalenceofclarithromycinoraldosageformsmarketedinnairobicountykenya