Ferric maltol API Manufacturers

General Description:

Ferric maltol, identified by CAS number 33725-54-1, is a notable compound with significant therapeutic applications. Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency. Ferric maltol was granted FDA Approval on 25 July 2019.

Indications:

This drug is primarily indicated for: Ferric maltol is indicated to treat iron deficiency in adults. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Ferric maltol undergoes metabolic processing primarily in: _In vitro_, ferric maltol metabolism is predominantly glucuronidation of maltol by UGT1A6 and sulfation. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Ferric maltol are crucial for its therapeutic efficacy: Ferric maltol dissociates in the gastrointestinal tract, leading to a T_max of 1.5-3.0 hours for iron concentrations. Mean serum iron increases by 14±6µmol/L in iron deficient patients following a single dose. a 60mg dose is approximately 14% bioavailable. 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 18±1% is present in the liver, and 2.6±1% is in the urine. Maltol has an AUC of 0.022-0.205h\*µg/mL and maltol glucuronide has an AUC of 9.83-30.9h\*µg/mL. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Ferric maltol is an important consideration for its dosing schedule: Maltol has a half life of 0.7h. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Ferric maltol exhibits a strong affinity for binding with plasma proteins: Data regarding the protein binding of ferric maltol is not readily available. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Ferric maltol from the body primarily occurs through: 39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate. Iron and ferric maltol are not excreted in the urine and unabsorbed ferric maltol is eliminated in the feces. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Ferric maltol is distributed throughout the body with a volume of distribution of: Data regarding the volume of distribution of ferric maltol is not readily available. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Ferric maltol is a critical factor in determining its safe and effective dosage: Data regarding the clearance of ferric maltol is not readily available. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Ferric maltol exerts its therapeutic effects through: Ferric maltol is used to provide supplemental iron to patients with an iron deficiency. It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity. Patients should be counselled regarding the risk of inflammatory bowel disease flares, iron overload, and accidental ingestion in children. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Ferric maltol functions by: Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Categories:

Ferric maltol is categorized under the following therapeutic classes: Antianemic Preparations, Blood and Blood Forming Organs, Hematinics, Hematologic Agents, Iron Compounds, Iron Preparations, Iron Trivalent, Oral Preparations, Organometallic Compounds, Parenteral Iron Replacement, Pyrans, UGT1A6 substrate. 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 maltol include:

• Water Solubility: 4.5-12mg/mL
• Melting Point: 300