Ferric pyrophosphate citrate API Manufacturers

General Description:

Ferric pyrophosphate citrate, identified by CAS number 1802359-96-1, is a notable compound with significant therapeutic applications. Ferric pyrophosphate citrate is a soluble iron replacement product. Free iron presents several side effects as it can catalyze free radical formation and lipid peroxidation as well as the presence of interactions of iron in plasma. The ferric ion is strongly complexed by pyrophosphate and citrate. FPC is categorized in Japan as a second class OTC drug. This category is given to drugs with ingredients that in rare cases may cause health problems requiring hospitalization or worst. It is also FDA approved since 2015.

Indications:

This drug is primarily indicated for: Ferric pyrophosphate citrate is indicated for the treatment of iron loss or iron deficiency to maintain hemoglobin and to reduce the prescribed dose of erythropoiesis-stimulating agent (ESA) required to maintain desired hemoglobin levels. Iron deficiency appears when the dietary intake does not meet the body's requirement or when there is chronic external blood loss. During acute blood loss, body iron stores are sufficient for accelerated erythropoiesis and restoration of iron homeostasis. But when the altered homeostasis remains for weeks to months then some supplement is needed. Some causes of iron deficiency include ectoparasitism, endoparasitism, hematuria, epistaxis, hemorrhagic skin, coagulopathy, thrombocytopenia, thrombocytopathia and gastrointestinal hemorrhage. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Ferric pyrophosphate citrate undergoes metabolic processing primarily in: Metabolism of ferric pyrophosphate resembles physiological processing of iron delivered into circulation after absorption by the gut. This is suggested due to the direct ability to trigger iron transfer to transferrin, between transferrin molecules and between transferrin and ferritin without the need of prior metabolism by the reticuloendothelial system. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Ferric pyrophosphate citrate are crucial for its therapeutic efficacy: The results of the present studies show that ferric pyrophosphate is as well absorbed in adults. The absorption of iron depends upon the route of entry. Ferric pyrophosphate has a very high bioavailability of 83-94%. The AUC and Cmax have a dose-dependent pharmacokinetic response, being of 675-1840 mcg.h/dL and 113-261 mcg/dL respectively when given in a dose from 2.5 to 10 mg. The time to reach maximum dose is approximate 4.5 hours. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Ferric pyrophosphate citrate is an important consideration for its dosing schedule: The half-life of ferric pyrophosphate is 1.48 hours. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Ferric pyrophosphate citrate exhibits a strong affinity for binding with plasma proteins: The main action site of ferric pyrophosphate is in the serum and thus it is highly bound to its targets such as ferritin and hemoglobin. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Ferric pyrophosphate citrate from the body primarily occurs through: After metabolism as endogenous iron, the excretion of ferric pyrophosphate follows the same pattern. In the body, iron is retained and in the absence of bleeding the excretion is very small. Most of the iron is absorbed in the gut and does not reach the feces. The excretion of iron can be done in urine, feces, sweat, hair, and nails. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Ferric pyrophosphate citrate is distributed throughout the body with a volume of distribution of: The apparent volume of distribution of ferric pyrophosphate after 4 hours of intravenous administration ranged from 0.765 to 0.859 L. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Ferric pyrophosphate citrate is a critical factor in determining its safe and effective dosage: The mean clearance rate of ferric pyrophosphate can range between 0.406 to 0.556 L/hour. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Ferric pyrophosphate citrate exerts its therapeutic effects through: Iron supplementation typically results in increases in serum iron, transferrin-bound iron, and iron-stored in the form of ferritin in hepatocytes and macrophages. The available iron is usually used in bone marrow for the synthesis of hemoglobin. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Ferric pyrophosphate citrate functions by: The usage of ferric pyrophosphate is based on the strong complex formation between these two species. Besides, the capacity of pyrophosphate to trigger iron removal from transferrin, enhance iron transfer from transferrin to ferritin and promote iron exchange between transferrin molecules. These properties make it a very suitable compound for parenteral administration, iron delivery into circulation and incorporation into hemoglobin. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Categories:

Ferric pyrophosphate citrate is categorized under the following therapeutic classes: Enzymes, Enzymes and Coenzymes, Hydrolases, Parenteral Iron Replacement, Peptide Hydrolases, Phosphate salts. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Ferric pyrophosphate citrate include:

• Water Solubility: Soluble
• Boiling Point: 309.6ºC at 760 mmHg