Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

Mechanism of action
The polynuclear iron (III) hydroxide core in IPC is surrounded at its surface by a number of non-covalently bound polymaltose molecules, which leads to an average total molecular weight of around 50 kDa.
The polynuclear iron core of IPC has a structure similar to that of the physiological iron storage protein ferritin. IPC is a stable complex and releases no large quantities of iron under physiological conditions. Due to its size, the magnitude of IPC diffusion taking place through the mucosa is around 40 times less than in most water-soluble iron (II) salts present in aqueous solution as a hexaaqua-iron (II) complex. Iron is absorbed in the intestines from IPC through an active mechanism.
Pharmacodynamics
The iron absorbed is bound to transferrin and is used for Hb synthesis in the bone marrow or stored primarily in the liver bound to ferritin.

Clinical Efficacy
The efficacy of Ferripel-3 syrup and Tiptipot Ferripel-3 compared to a placebo or similar preparations with different iron formulations in terms of normalising haemoglobin values and replenishing iron stores has been demonstrated in numerous clinical studies in infants, children, adolescents and adults. Both solid and liquid galenic forms of IPC were used in these studies. The primary goal of an oral iron replacement is to maintain the body’s own iron stores within normal limit values (to prevent an iron deficiency, e.g. in case of increased requirements), replenish iron stores or correct existing iron deficiency anaemia.

Clinical studies in adults
A total of 11 controlled clinical studies have been carried out with IPC mono- preparations in comparison with a placebo and/or oral iron (II) preparations.
A total of more than 900 patients were involved, and approximately 500 of these patients received IPC mono-preparations. The patient population studied demonstrated no relevant differences in haematological and iron parameters (haemoglobin (Hb), mean red blood cell haemoglobin (MCV), serum ferritin) at the start of treatment. The oral iron replacement with IPC at a dose of 100–200 mg iron/day for several weeks up to a maximum of 6 months demonstrated a clinically relevant increase in iron and haematological parameters at the end of treatment compared to those at the start of treatment. The improvement in haematological parameters (Hb, MCV, serum ferritin) after a 12-week treatment with IPC was comparable to treatment with iron (II) sulphate.
The efficacy of IPC compared to iron (II) sulphate was investigated on the basis of a meta-analysis of 6 prospective, randomised clinical studies in adult patients with iron deficiency anaemia. The total number of patients included in the study was 557; 319 patients received IPC and 238 patients iron (II) sulphate. The pooled mean haemoglobin values at the start of treatment were 10.35 ±0.92 g/dL (IPC) and 10.20 ±0.93 g/dL (iron (II) sulphate). After an average treatment period of 8 to 13 weeks with equivalent posology, mean haemoglobin values were determined 12.13 ±1.19 g/dL (IPC) and 11.94 ±1.84 g/dL (iron(II) sulphate), p=0.93increases in haemoglobin were greater after a longer treatment duration for both iron formulations.

Clinical studies in children and adolescents
The use of Ferripel-3 syrup and Tiptipot Ferripel-3in children and adolescents (18 years old or younger) was investigated in a number of clinical studies involving over 1000 patients. The efficacy of Ferripel-3 syrup and Tiptipot ferripel-3in terms of improving iron values compared to the placebo or comparable preparations with different iron formulations was thereby confirmed.

Pharmacokinetic Properties