Investigators prepared different sizes of iron particles samples. Following that, an in-vitro ionization reaction was involved by placing equal amounts of iron suspensions into 0.1M hydrochloric acid solution (stomach environmentsimulation). The concentration of iron ions (Fe2+) in the samples was determined versus time. The concentration of iron ions in the samples was determined using the spectrophotometric method by measuring the absorbance at a wavelength of 511 nm in relation to a colored indicator – phenanthroline – according to the literature data this value selectively corresponds to maximum absorbance for iron (II) – phenanthroline complex.
In this study, the elemental iron powder was used with different particle size medians of 5.2 μM (Reference A), 9.5 μM (Reference B), and 8.5 μM (Reolin). The iron particle sizes characteristics are shown below.
Pharmaceutical preparations were made using the particles investigated to confirm the different tendencies of the release characteristics. Reference A with a size of 5.2 micrometers (median D50) tends towards exponential iron ionsrelease.
Reol that contains iron particles with a size of 8.5 micrometers leads to linear-like kinetics with the maximum concentration obtained in the time corresponding to the gastric passage. Particles of reference B with a size of 9.5 micrometers (median D50) behave like the release-retardant product.
As shown in the graph below, iron particles from the size range of 5.2 micrometers (calculated as median D50) imitate theexponential character of the reaction. However, a slight increase in the particle size beyond the threshold of 7.0 micrometers (in the study-median of 8.5 micrometers) leads to the transformation of this dependence into linear kinetics.
The experimentally adjusted size of elemental iron particles in Reolin reduces the potential for elevated levels of unused iron ions in the body – a characteristic feature of iron salts’ preparations.
The excess of iron ions leads to an imbalance of a number of bacterial flora, which is especially dangerous in humans and can bring about the following cases:
Reduced immunity to bacterial infection
Sepsis caused by gram-negative bacteria
Pathological increase in the activity of some microorganisms that colonize the human digestive system
