The bioequivalence study of Folifer-Z®: a new formulation of sustained-release iron and zinc

The bioequivalence of Folifer-Z® tablets, a new sustained-release iron and zinc formulation was evaluated and compared to that of Fefol-Z® capsules in 30 healthy male subjects. Each subject received a single oral dose of either product according to a randomized two-way crossover design. A washout pe...

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Published inInternational journal of pharmaceutics Vol. 178; no. 2; pp. 171 - 181
Main Authors Salhab, Abdulazim S., Zmeili, Suheil M., Gharaibeh, Munir N., Elayan, Hamzeh H., Sallam, Elsayyed, Al Deleq, Suleiman
Format Journal Article
LanguageEnglish
Published Amsterdam Elsevier B.V 15.02.1999
Elsevier
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ISSN0378-5173
1873-3476
DOI10.1016/S0378-5173(98)00368-8

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Summary:The bioequivalence of Folifer-Z® tablets, a new sustained-release iron and zinc formulation was evaluated and compared to that of Fefol-Z® capsules in 30 healthy male subjects. Each subject received a single oral dose of either product according to a randomized two-way crossover design. A washout period of 1 week was allowed after each treatment. Blood samples were obtained over a 24-h period, and iron and zinc concentrations were measured. The pharmacokinetic parameters of Folifer-Z® were C max (103±46.2 μg/dl), T max (5.93±2.94 h) and AUC 0–24 h (1937±706 μg/dl per h), whereas the corresponding Fefol-Z® values were C max (109±41.5 μg/dl), T max (6.64±2.54) and AUC 0–24 h (1865±699 μg/h per dl). Analysis of variance on log-transformed data for C max and AUC 0–24 h revealed lack of significant differences among the two formulations. The mean relative bioavailability of AUC test/AUC reference was 1.07 (90% confidence interval range: 99–115%) and for C max test/ C max reference was 0.96 (90% confidence interval range: 88–105%). Regarding the zinc results, the pharmacokinetic parameters of Folifer-Z® values were C max (101±20.7 μg/dl), T max (4.86±1.53 h) and AUC 0–24 h (1944±202 μg/h per dl), while the corresponding Fefol-Z® values were C max (102±20.7), T max (4.93±1.51) and AUC 0–24 h (1953±200). Analysis of variance on log-transformed zinc data for C max, T max and AUC 0–24 h revealed lack of significant difference among the two formulations. The mean relative bioavailability of AUC test/AUC reference was 0.98 (90% confidence interval range; 95–101%) and for C max test/ C max reference was 0.92 (90% confidence interval range: 89–96%). The results also indicate a possible inhibition of zinc absorption by iron content of both formulations. It is concluded that Folifer-Z® product is bioequivalent to Fefol-Z® product.
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ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(98)00368-8