In Vitro Dissolution Profile of Two Commercially Available Iron Preparations

Abstract

Background: Current scientific evidence indicates that anemia in pregnancy, regardless of severity, is associated with an increased risk of maternal and fetal mortality. There is little published information about the bioavailability and bioequivalence of formulations containing both iron and folic acid. However, in vitro dissolution studies can provide important information on the likely relative bioavailability of various formulations. Aim: The objective of our study was to compare the in vitro dissolution of two similar commercially available formulations of iron-and folic acid-containing supplements, Folifer Ò (Bialport -Produtos Farmaceˆuticos, S.A., Portugal) and Ferroliver Ò (SM Pharma c.a., Venezuela), in order to determine the in vitro availability of their iron content. Folifer Ò and Ferroliver Ò were chosen because they contained similar amounts of elemental iron. Methods: The amount of iron released from each tablet was evaluated over a 4-hour period in three dissolution media replicating gastric or intestinal juices with pH values ranging from 1.5 to 6.9. The samples were then titrated with a solution of cerium ammonium sulfate in order to calculate the amount of iron released in each specific pH condition. The percentage of dissolved iron was calculated as a cumulative frequency, using the percentage of dissolved iron at all timepoints. The dissolution similarity between the two commercially available formulations was evaluated using the e 2 statistic formula. Results: During a 4-hour dissolution test, Folifer Ò released 59.4 mg of iron compared with 48.5 mg released by Ferroliver Ò . The value obtained for the similarity factor, an indicator of likely bioequivalence, was 41. Conclusion: These data suggest that Folifer Ò releases more iron than Ferroliver Ò , and that the two formulations are not equivalent in vitro. The superior dissolution of ferrous sulfate with Folifer Ò compared with ferrous fumarate in Ferroliver Ò might be responsible for the observed difference.

Formulation and Evaluation of Nutraceutical Tablet Using Herbal Drurs by Direct Compression Method

“…12,13 Friability-Friability of all formulations was found to be0.14±0.045 to 0.31±0.0.12 %.The friability of clove and cinnamon containing tablet was found to be in acceptable limit i.e. less than 1%.…”

“…The thickness, hardness, weight variation, and friability of nutraceutical tablet were founded to be in acceptable limit. It shows that the herbal drugs containing nutraceutical tablets have satisfactory disintegration profile due to their hardness within range of standard limit 12 .…”

Suplementy diety – specyficzna żywność

“…Nadal niewiele jest badań dotyczących dostępności farmaceutycznej suplementów diety. Niezależnie przeprowadzone eksperymenty według wytycznych Farmakopei Amerykańskiej dowodzą jednak, że niektóre z przebadanych suplementów diety z witaminą A [61], luteiną [62] oraz żelazem [63] charakteryzowały się niskim uwalnianiem substancji czynnej z postaci produktu. Badane produkty w kapsułkach z luteiną uwolniły zaledwie 20% substancji w ciągu 180 min badania, podczas gdy z tabletek uwolniło się nie mniej niż 80% w tym samym czasie [62].…”

Powszechność Suplementów Diety a Zagrożenia Związane Z Ich Stosowaniem

“…Ograniczona jest ilość informacji na temat dostępności farmaceutycznej suplementów diety. Część z nich dowodzi jednak, że suplementy diety zawierające luteinę [30], żelazo [31] czy witaminę A [32] charakteryzują się niskim uwalnianiem substancji czynnej z postaci leku.…”