Ferrous sulfate anhydrous API Manufacturers

General Description:

Ferrous sulfate anhydrous, identified by CAS number 7720-78-7, is a notable compound with significant therapeutic applications. Iron deficiency anemia is a large public health concern worldwide, especially in young children, infants, and women of childbearing age. This type of anemia occurs when iron intake, iron stores, and iron loss do not adequately support the formation of erythrocytes, also known as red blood cells. Ferrous sulfate is a synthetic agent used in the treatment of iron deficiency. It is the gold standard of oral iron therapy in the UK and many other countries.

Indications:

This drug is primarily indicated for: Ferrous sulfate is used for the prevention and treatment of iron deficiency anemia in adults and children. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Ferrous sulfate anhydrous undergoes metabolic processing primarily in: The metabolism of iron is complex. Normally, iron exists in the ferrous (Fe2+) or ferric (Fe3+) state, but since Fe2+ is oxidized to Fe3+, which hydrolyzes to insoluble iron(III)hydroxides in neutral aqueous solutions, iron binds to plasma proteins and is either transported or stored throughout the body. There are three proteins that serve to regulate the storage and transport of ingested iron. The first protein , transferrin, transports iron in both the plasma and extracellular fluid. Ceruloplasmin in the plasma and hephaestin on the enterocyte participate in the oxidation and binding of iron to transferrin. The main role of transferrin is the chelation of iron to prevent the production of reactive oxygen species, while facilitating its transport into cells. The transferrin receptor, located on many cells that require iron, binds the transferrin complex and internalizes this complex. Ferritin is a protein that stores iron, making it readily available for body requirements. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Ferrous sulfate anhydrous are crucial for its therapeutic efficacy: Approximately 5 – 10% of dietary iron is absorbed, and this absorption rate increases to up to 30% in iron deficiency states. Oral iron supplements are absorbed up to 60% via active and passive transport processes. Gastrointestinal absorption of iron occurs via strict regulation by the enterocyte and duodenal cytochrome and ferric reductase enzymes. The hormone hepcidin heavily regulates iron absorption and distribution throughout the body. The median time to maximum serum concentration (Tmax) is generally 4 hours after administration. Between 2-8 hours post administration, average serum iron concentrations fluctuate by 20%, according to one study. Bioavailability of iron depends on whether it is administered in a film coated tablet or enteric coated tablet. One pharmacokinetic study in healthy volunteers revealed a 30% bioavailability for enteric coated tablets. The AUC of enteric coated tablets varied between a lower limit of -46.93 to 5.25 µmolxh/l. Cmax is higher for film coated tablets, ranging from 3.4 to 22.1 µmol/h/l. It is advisable to take ferrous sulfate with ascorbic acid, as this practice may increase absorption. Avoid antacids, tea, coffee,tea, dairy products, eggs, and whole-grain bread for at least an hour after taking ferrous sulfate. Calcium can decrease iron absorption by 33% if taken concomitantly. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Ferrous sulfate anhydrous is an important consideration for its dosing schedule: The half-life of orally administered iron is not readily available in the literature, with total effects lasting 2-4 months (congruent with the red blood cell life span) with an onset of action of 4 days and peak activity at 7-10 days. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Ferrous sulfate anhydrous exhibits a strong affinity for binding with plasma proteins: The protein binding for ferrous sulfate is equal to or greater than 90%. It is bound to transferrin and ferritin, ferroportin, myoglobin, and other enzymes. Approximately 60% of iron is located in the erythrocytes as part of hemoglobin. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Ferrous sulfate anhydrous from the body primarily occurs through: Oral iron is recycled, with some loss in the urine, sweat, and desquamation. Some iron can be lost during menstrual bleeding This loss is balanced by changes in intestinal absorption. The enzyme hepcidin promotes the excretion of iron via the sloughing of enterocytes with ferritin stores into the feces. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Ferrous sulfate anhydrous is distributed throughout the body with a volume of distribution of: About 60% of iron is distributed the erythrocytes. The remainder of the iron is found in muscle tissues (as a part of myoglobin), and in a variety of different enzymes, as well as in storage form. Most stored iron is in the form of ferritin, which can be found in the liver, bone marrow, spleen and, and muscle. Iron crosses the placenta and is also found in breast milk. This metric indicates how extensively the drug permeates into body tissues.

Pharmacodynamics:

Ferrous sulfate anhydrous exerts its therapeutic effects through: Ferrous sulfate replenishes iron, an essential component in hemoglobin, myoglobin, and various enzymes. It replaces the iron that is usually found in hemoglobin and myoglobin. Iron participates in oxygen transport and storage, electron transport and energy metabolism, antioxidant and beneficial pro-oxidant functions, oxygen sensing, tissue proliferation and growth, as well as DNA replication and repair. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Ferrous sulfate anhydrous functions by: Iron is required to maintain optimal health, particularly for helping to form red blood cells (RBC) that carry oxygen around the body. A deficiency in iron indicates that the body cannot produce enough normal red blood cells. Iron deficiency anemia occurs when body stores of iron decrease to very low levels, and the stored iron is insufficient to support normal red blood cell (RBC) production. Insufficient dietary iron, impaired iron absorption, bleeding, pregnancy, or loss of iron through the urine can lead to iron deficiency. Symptoms of iron deficiency anemia include fatigue, breathlessness, palpitations, dizziness, and headache. Taking iron in supplement form, such as ferrous sulfate, allows for more rapid increases in iron levels when dietary supply and stores are not sufficient. Iron is transported by the divalent metal transporter 1 (DMT1) across the endolysosomal membrane to enter the macrophage. It can then can be incorporated into ferritin and be stored in the macrophage or carried of the macrophage by ferroportin. This exported iron is oxidized by the enzyme to ceruloplasmin to Fe3+, followed by sequestration by transferrin for transport in the serum to various sites, including the bone marrow for hemoglobin synthesis or into the liver. Iron combines with porphyrin and globin chains to form hemoglobin, which is critical for oxygen delivery from the lungs to other tissues. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Ferrous sulfate anhydrous belongs to the class of inorganic compounds known as transition metal sulfates. These are inorganic compounds in which the largest oxoanion is sulfate, and in which the heaviest atom not in an oxoanion is a transition metal, classified under the direct parent group Transition metal sulfates. This compound is a part of the Inorganic compounds, falling under the Mixed metal/non-metal compounds superclass, and categorized within the Transition metal oxoanionic compounds class, specifically within the Transition metal sulfates subclass.

Categories:

Ferrous sulfate anhydrous is categorized under the following therapeutic classes: Anemia, Iron-Deficiency, Delayed-Action Preparations, Hematinics, Iron Compounds, Iron Preparations, Minerals, Organometallic Compounds, Pharmaceutical Preparations, Polyvalent cation containing laxatives, antacids, oral supplements. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Ferrous sulfate anhydrous include:

• Water Solubility: 25.6 g/100 mL
• Melting Point: 64
• Boiling Point: > 300 °C
• logP: -0.84
• pKa: -3