The aim of the present study was to evaluate and compare the dissolution profiles of seven commercial products containing ferrous sulfate and fumarate marketed in Argentina, based on their in vitro dissolution characteristics using USP Apparatus 2. INTRODUCTION Iron deficiency is one of the most common nutritional deficiencies throughout the world, and the most severe form manifests as anemia. Both iron deficiency and anemia have severe repercussions on immune function, physical capacity for work, and attention span (1–3). In females, there is a risk of iron deficiency due to regular menstrual blood loss and the increase of iron demand during pregnancy. Peptic ulcer disease and nonsteroidal, anti-inflammatory drugs are common causes of blood (and therefore iron) loss. Anemia may be secondary to inflammatory or infectious diseases (4–7) or to a diet lacking other micronutrients essential for iron metabolism such as vitamins C, A, B12, and folate (8). Given the frequency of iron deficiency and diseases resulting in iron loss, it is not surprising that iron preparations are among the most commonly prescribed drugs in Argentina and that iron salts are components of many vitamin and mineral supplements (9). In fact, about 10% of elderly persons ingest over-the-counter preparations containing iron, and the standard medical care for pregnant woman includes iron supplementation. Iron absorption takes place at the duodenum and the upper jejunum of the gastrointestinal system. Even if there is no absorption in the stomach, this organ contributes to the process by the secretion of hydrochloric acid and enzymes, which help not only to set iron free from the food matrix but also to make it soluble (10–12). Iron absorption may be affected by a combination of different factors, such as the type of ingested iron, the nutritional status of the individual for this element, and the presence of absorption activators or inhibitors existing in the intestinal lumen together with iron (13–18). Iron is found in foods in two different groups, hemic iron and non-hemic iron. The heme-type iron is a part of hemoglobin, myoglobin, cytochromes, and many other heme proteins, which are present principally in animal foods. The heme group, which is present in all of these proteins, is a complex organic ring, called protoporphyrin, bound to a divalent iron atom that has six coordination sites. Four of the sites are bound to the protoporphyrin, one to a nitrogen atom of the protein fraction, and the remaining site is available to bind to an oxygen molecule. The non-hemic type iron corresponds to iron that is not bound to a heme group and includes inorganic iron salts that are found principally in vegetal foods as well as in the principal pharmaceutical preparations utilized for iron deficiency therapy (19). Because non-hemic iron is found in a higher proportion in the diet, its absorption is significantly modified by the nutritional status of the individual for this element. Thus, if the natural iron depots are depleted, iron absorption will increase, and if the depots are saturated, iron absorption will decrease. There are different physiological states (e.g., growth and pregnancy) that produce a substantial increase in the absorption of this metal because of an increase in the synthesis of new biomolecules that have iron in their structure (19–23). The most therapeutically active form of iron is the ferrous form (Fe+2). Dietary ferric (Fe+3) form is converted to the ferrous form in the stomach. This reduction is greatly promoted by the presence of H+ and dietary ascorbic acid. The great advantage of this conversion is that the ferrous form (as compared with the ferric form) is much more easily released from the organic ligands to which it is bound and stays soluble (24) The commercially available salt forms mainly include ascorbate, citrate, fumarate, gluconate, oxide, succinate, and sulfate. The solubilities of these various salts in water or aqueous media are significantly different, and hence it is reasonable to expect that their dissolution rates could vary. Further complications and variations in the release of iron may arise because of changes in the formulation of a product with any given salt form and the presence *Corresponding author. e-mail: asegall@ffyb.uba.ar dx.doi.org/10.14227/DT190412P47
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