Preparation and Standardisation of Saccharated Iron Oxide for Intravenous Administration

Nissim, J. A.; Robson, J. M.

doi:10.1016/s0140-6736(49)91958-3

Cited by 33 publications

(11 citation statements)

References 3 publications

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“…The pH of the preparations in aqueous solutions was regulated within the range 1 to 8, with 0.1 and 1.0 N hydrochloric acid, in accordance with the method of Nissim & Robson (1949). After the addition of the hydrochloric acid the iron concentration in all the solutions was Fe 1 mg/ml.…”

Section: Stability At Different Phmentioning

confidence: 99%

Studies on a New Intramuscular Haematinic, Iron‐sorbitol

Lindvall

Andersson

1961

British Journal of Pharmacology and Chemotherapy

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A new iron preparation for intramuscular use is described. It contains a complex of iron, sorbitol and citric acid. Its properties in comparison with several other complexes, particularly iron-dextran, have been studied. The preparation is stable in serum, is hypertonic, does not produce haemolysis, and affects coagulation only at very high concentrations, such as are reached only in vitro. Absorption from muscle takes place very rapidly; two-thirds of the iron is removed within 3 hr, and there is a very rapid increase in the serum-iron concentration. In experimental animals, the maximum level is reached after about 20 min and in man after about 2 hr. Disappearance from the serum takes place rapidly. The preparation contains a small amount of a fraction which reacts with transferrin and is dialysable. In man, about 30% of the total dose of iron is excreted through the kidneys during the first 24 hr after injection, the greater part of the excretion taking place during the first few hours.

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Section: Stability At Different Phmentioning

confidence: 99%

Studies on a New Intramuscular Haematinic, Iron‐sorbitol

Lindvall

Andersson

1961

British Journal of Pharmacology and Chemotherapy

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“…In 1947, a substantial reduction in toxicity of parenteral iron was reported when the metal was chelated with saccharate moieties . Two years later, preparation and standardization of iron sucrose (IS) were elucidated . Over the last 60 years, IS has been widely prescribed and became the most common IV iron treatment in Europe, North America, and Japan owing to its effectiveness and proven synergy with erythropoiesis‐stimulating agents in the treatment of severe forms of iron‐deficiency anemia .…”

Section: Introductionmentioning

confidence: 99%

Iron sucrose: assessing the similarity between the originator drug and its intended copies

Francesco

Philipp

Borchard

2017

Annals of the New York Academy of Sciences

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Iron sucrose (IS) is a complex nanocolloidal intravenous suspension used in the treatment of iron-deficiency anemia. Follow-on IS products (iron sucrose similars (ISSs)) have obtained marketing authorization by the generic pathway, implying that identical copies of IS may be manufactured. However, recent prospective and retrospective clinical studies showed discrepancies in clinical outcomes, which might be related to differences in physicochemical properties. The aim of this work is to measure and compare the physicochemical properties of IS and three ISSs available in the market using innovative analytical procedures. The comprehensive elucidation of size, size distribution, morphology, and stability of these complex drugs revealed very significant differences between the products. This study serves to provide the basis to define critical quality attributes that may be linked to differences in clinical outcome and thus may contribute to an adequate regulatory approach for IS and its follow-on products.

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“…A variety of sugars and polyols are capable of forming stable and soluble complexes with iron (Charley et al 1963, Spiro & Saltman 1969. Hence, the stabilizing component in most iron preparations are carbohydrate in nature (Nissim & Robson 1949, Fletcher & London 1954, Lindvall & Andersson 1961.…”

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confidence: 99%

Disposition in Rats of the Carbohydrate Polymer in Ferastral®— an Iron‐poly (sorbitol‐gluconic acid) complex

Lake-Bakaar

1977

Scandinavian Journal of Haematology

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The disposition and pharmacokinetics in rats of 14C-sorbitol-Ferastral@ has been studied as an initial step towards elucidating the metabolic fate of the polymeric organic moiety. The period of time studied was 24 h. Following i.v. administration of a dose corresponding to 10 mglkg of iron approximately 60 % of the isotope was found in the urine after this period of time. A further 3 % was demonstrated in the faeces whilst the expired air accounted for about 10 % in the form of 14CO,. Thus, a relatively large proportion of the radiolabel was promptly excreted via the kidneys whilst the expired air and probably bile constituted secondary excretion routes. The physico-chemical nature of the urinary product was similar to the parent carbohydrate compound. The residual 14C radioactivity was distributed mainly between the liver, which contained approximately 45 % of the retained label, carcass with 36 % and large intestine with 7 %. The plasma disappearance pattern was biphasic. Similar experiments with the 14C-sorbitol polymer starting material were performed for purposes of comparison.

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Preparation and Standardisation of Saccharated Iron Oxide for Intravenous Administration

Cited by 33 publications

References 3 publications

Studies on a New Intramuscular Haematinic, Iron‐sorbitol

Studies on a New Intramuscular Haematinic, Iron‐sorbitol

Iron sucrose: assessing the similarity between the originator drug and its intended copies

Disposition in Rats of the Carbohydrate Polymer in Ferastral®— an Iron‐poly (sorbitol‐gluconic acid) complex

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