University of Khartoum

Comparative Stability Study of Reconstituted Cefuroxime Axetile Suspension at 2-8 ºC in Yemen

Comparative Stability Study of Reconstituted Cefuroxime Axetile Suspension at 2-8 ºC in Yemen

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Title: Comparative Stability Study of Reconstituted Cefuroxime Axetile Suspension at 2-8 ºC in Yemen
Author: Ahmed, Ali A.S.; Shayoub, Mohammed E.A.; Kassem, Abdulkarim K.Y.
Abstract: Cefuroxime axetil, an ester pro-drug of Cefuroxime, is a 50:50 mixture of diastereoisomers A and B resulting from esterification of Cefuroxime with racemic 1-acetoxyethyl bromide. CFA is the orally absorbed ester pro-drug of the Cefuroxime sodium, since Cefuroxime sodium is not absorbed orally. Cefuroxime axetil is a second generation Cephalosporin which attach to penicillin binding proteins and inhibits bacterial cell wall synthesis and results in bacterial cell death. Objective The aim of the present study was to evaluate the comparative stability of Cefuroxime axetil brands for oral suspension (125mg/5ml) after reconstitution and storage at 2-8ºC for 14 days and tested at 0,3,6,10,14 days. Methodology The stability testing was performed on a total of brands and three batches from each company (including innovator brand), obtained in two areas in Yemen, cold and dry area (Sana’a) and hot and humid area (Hodeida). The five brands were coded as A, B, C, D and E. The stability testing was performed by using USP monograph for CFA for oral suspension. The samples were visually examined for physical change and analysed for their contents of impurities, remaining Cefuroxime axetil and amount of Cefuroxime axetil released in vitro. This study was performed at the National Drug Quality Control Laboratory-Ministry of Health-Sana’a. Results After testing, brands A and E of the products complied while brands B, D and C of the products did not comply with the USP, 2008 and B.P, 2010 standards. The decomposition products from the hydrolysis of Cefuroxime axetil were Cefuroxime and Δ3- isomers but the main decomposition product is Cefuroxime. The order of the reaction was zero-order for all samples. Two products were considered to demonstrate good physical and chemical stability over the course of the study, viz. sample A and E. There was no significant difference at 5% level between degradation constant innovator brand and the other products during utilization period. The decomposition product of products selected from Sana’a was less than that of products selected from Hodeida city. Sample B released lower amount of CFA in vitro at all time points. After the 10th day storage, sample D showed a large reduction in the amount of CFA released in vitro. Conclusion Only products A and E complied with USP standards and BP standards during utilization period.
URI: http://khartoumspace.uofk.edu/handle/123456789/19598
Date: 2015


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