API & Fine Pharmaceutical Manufacturer in India
How Ferric Maltol gained so much acceptance worldwide
Published on: September 27, 2023

How Ferric Maltol gained so much acceptance worldwide

What is Ferric Maltol?

Ferric Maltol is a complex of ferric iron and maltol (3-hydroxy-2-methyl-4-pyrone), a naturally occurring sugar derivative found in many food products, which is highly selective for iron. The iron Maltol complex is stable at a physiologic pH and, remains strongly chelated until the point of absorption in the gut. Ferric iron is readily transported across the gut lumen whereas maltol is separately absorbed, metabolized, and rapidly eliminated in the urine.

Oral iron replacement therapy, usually in the form of ferrous salts, offers convenience in terms of low cost and easy administration. However, the effectiveness of many oral formulations may be reduced by limited bioavailability, because only 10–20% of iron from oral ferrous formulations is estimated to be absorbed.

Administration of IV iron may require a hospital or clinic setting, and there are small but potentially serious risks of anaphylaxis, hypophosphatemia, and iron overload. Ferric maltol has been rationally designed to optimize the absorption and tolerability of oral iron. It has been approved by the European Medicines Agency, Swiss Medic, and the US Food and Drug Administration and is commercially available in Europe and the United States for the treatment of adults with iron deficiency, with or without anemia.

Animal model studies of ferric maltol have demonstrated that the dissociated iron is absorbed even in models of intestinal damage and more effective iron absorption from the iron–maltol complex was recorded when iron was in the ferric versus ferrous form. In human studies, iron from ferric maltol was at least as well absorbed as ferrous iron, and it was better absorbed from the complex than from simple ferric salts.

Unabsorbed iron can form reactive hydroxyl radicals in the gut, leading to mucosal irritation or damage. The resulting gastrointestinal adverse events, such as nausea, epigastric discomfort, and constipation, may reduce patients’ willingness to continue treatment.

Iron absorption was increased five-fold when ferric maltol was taken on an empty stomach versus with food. Uptake of Ferric Maltol was rapid, with maximum concentrations achieved within 2–3 h after administration in adults with IBD. In iron-deficient adults, serum iron levels increased substantially following oral administration of ferric maltol, whereas considerably less absorption was seen in iron-replete adults.

In adults with IBD, maltol and maltol glucuronide concentrations increased rapidly and dose proportionally whereas in adolescents (aged 10–17 years), maltol concentrations increased rapidly and dose dependently.

Approved for medical use in February 2016 in the European Union, Ferric Maltol is a medication that contains iron for treating low iron stores in adults. Ferric maltol is an oral supplement sold under the brand names Feraccru (EU) and Accrufer (US).

The bioavailability is increased as compared to Iron II, in Ferric Maltol by complexing Iron III atoms with three maltol molecules. However, in this process, Ferric Maltol isn’t deposited in the duodenum as insoluble phosphate and ferric hydroxide. Ferric Maltol is considered a potential treatment for deficiency in iron in the human body as described in literature since the late 1980s. Accrufer is used to treat the symptoms of iron deficiency as prescription medicine, with or without other medications. The class of drugs called iron products is the group to which Accrufer belongs. However, the safety and effectiveness of Ferric Maltol are yet not approved in children.

Iron deficiency can lead to Iron Deficiency Anemia (IDA), which can be harmful to the health conditions of an individual. This might be specifically harmful at the time of pregnancy, which can cause harm to the mother as well as the baby.

Deficiency of iron that causes Iron Deficiency (IDA) can be treated or prevented with the iron supplementation available in the form of Ferric Maltol supplements. But before using Ferric Maltol as the supplementation for deficiency of iron, a doctor or a medical expert should always be consulted to know about the benefits as well as the side effects that might be caused due to such supplements.

How Ferric Maltol gained so much acceptance worldwide

What Are The Side Effects?

Fatigue, loss of weight, blood in the stool, bleeding in the rectal region, pain in the abdomen, persistent diarrhea, diabetes, darkening of the skin, irregular rhythm of the heartbeat, pain in the joints, chronic fatigue, swelling of the throat, tongue, lips or the face of an individual, difficulty in breathing, and hives are some of the side effects that might become serious after the use of Ferric Maltol supplements like Accrufer.

Bloating and pain, abdominal discomfort, vomiting, nausea, color change of the stool, constipation, diarrhea, and flatulence are some of the most common side effects of using the drugs containing Ferric Maltol. Iron overload in the body and inflammatory bowel disease flare are some of the risks that are increased by the serious side effects caused by Ferric Maltol supplements such as Accrufer. Ferric Maltol as an iron supplement for replenishing the iron stores of the body for the patient.

This product however has no such severe allergic reactions. The doctor often analyzes the benefits over the risks posed by this medication before prescribing it to a patient.

Interactions

There has been no systematic interaction studies conducted with Ferric Maltol. Similar to that of calcium and magnesium salts and tetracycline antibiotics, food reduces its uptake from the gut with the use of Ferric Maltol.

The uptake of many drugs such as levodopa, levothyroxine, quinolone antibiotics, tetracycline antibiotics, and bisphosphonates is inhibited by iron. Fluoroquinolones area group of drug which is to be completely avoided with Ferric Maltol as they cause serious side effects.

Potentially leading to low blood pressure or even collapse, combining intravenous iron with the Ferric Maltol supplements can result in a faster release of iron into the blood of an individual. It is proven that the combination of iron with Dimercaprol is toxic to kidneys. With the excretion of iron, the antibiotic chloramphenicol interferes with the iron incorporation into the red blood cells.

The effects of methyldopa might be lowered when the blood pressure is reduced by the intake of iron present in Ferric Maltol supplements. The UGT1A6 metabolizes Maltol. The increase of the concentration of Maltol in the body due to the effects of inhibitors of the enzyme is still unknown.

How to use Ferric Maltol?

Ferric Maltol is generally used to treat or prevent iron deficiency. The body requires iron to produce red blood cells which keep individuals in good health. Iron deficiency might lead to several diseases like anemia, which can result in the deficiency of hemoglobin which is essential for the blood to carry oxygen.

Medical experts should always be consulted before refilling or starting the dosage of Ferric Maltol supplements. Usually directed by the doctor to be taken twice daily, Ferric Maltol supplements should be taken orally on an empty stomach at least one hour before or two hours after a meal. The capsules should be swallowed whole, i.e. the capsule must not be chewed, broken, or opened.

After the intake of this medication, the patient is advised not to lie down for at least 10 minutes. For the benefit of remembering, the medicine should be taken at a particular time of the day and regularly for best results. Treatment is to be continued as long as necessary until ferritin levels are within the normal range. Duration of treatment depends on severity of iron deficiency but generally at least 12 weeks of treatment is required.

Precautions to Take:

 Yes, it’s extremely important for a patient to inform their doctor or pharmacist about any allergies, medical conditions, and medications they are taking (including herbal and over-the-counter products) before starting a new medication. This helps the doctor or pharmacist to make an informed decision about the safety and effectiveness of the medication for the patient and to avoid any potential interactions or adverse reactions.

Additionally, it’s also important to inform the doctor or pharmacist about any other medical conditions that may affect the metabolism or elimination of the medication. This information can help the doctor adjust the dose or choose a different medication that is safer for the patient.

Lastly, if a woman is breastfeeding, she should always consult with her doctor before starting a new medication as some medications may be harmful to the nursing baby.

Use of Ferric Maltol in iron supplements

Ferric Maltol is used for manufacturing iron supplements which are sold by the brand names Feraccru (EU) and Accrufer (US). Accrufer is the most widely used iron supplement product.

Comprising 201.5 milligrams of Maltol and 30 milligrams of iron, Accrufer (ferric Maltol) capsules are an iron replacement product meant for oral administration. As a complex with a trimaltol ligand, ferric maltol contains iron in a stable state of ferric. With a molecular formula of (C6H5O3)3FE, Ferric Maltol is a 3hydroxy-2-methyl-4H-pyrane-4-one iron(III) complex (3:1) with a molecular mass of 431.2.

Sodium Lauryl Sulfate, magnesium stearate, lactose monohydrate, crospovidone (Type A), and anhydrous silica are present in Ferric Maltol supplements as inactive ingredients. The other elements such as titanium dioxide, gelatin, FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Blue No. 1 are used in the manufacturing of the capsule shell. Propylene glycol, iron oxide black, ethanol, and ammonium hydroxide are used in making the ink used for printing and marking on the shells.

A dose of 30 mg twice daily is the recommended dosage for Accrufer, similar to that of the other Ferric Maltol supplements on the market. At least 12 weeks of treatment is required according to a general survey performed, but the severity of the iron deficiency will show affect how much time this medication will take to provide the benefits toward a cure. Until the normal levels of ferritin are achieved, the medication should be continued daily for treatment.

Frequently Asked Questions on: How Ferric Maltol gained so much acceptance worldwide
What is ferric maltol used for?

Used to treat low iron levels in the bloodstream of an individual, Ferric Maltol is an iron supplement that can treat diseases like anemia. The maintenance of proper health and production of red blood cells require iron as an important mineral to do so.

What can cause low iron?

Pregnancy, chronic blood loss, and lack of iron content in an individual’s diet are the common causes for which an individual might be diagnosed with iron deficiency. The inability to absorb iron from the diet can also lead to iron deficiency. In that case, the iron injections should be administered for the treatment purposes of the patients, when the oral methods become ineffective. However, most of the time, iron deficiency is treated with iron supplementation or by setting up a diet plan which includes iron-rich food.

How do you fix iron deficiency?

The replenishment of iron stores in an individual’s body who is been diagnosed with iron deficiency isn’t an overnight process. The process of replenishing the iron reserves of the body might take up to as long as several months since it is a gradual process. However, the improvement in the health of the patient might be observed within a week or so after the supplementation of iron is started. The measurement of iron stores in the body should be done with a blood test conducted under the supervision and recommendation of a doctor or a medical expert.

How can I raise my iron levels quickly?

Taking the iron supplements that have been administered intravenously or taking iron orally along with the Vitamin C supplementation is often the quickest way to replenish the iron stores of the individual’s body who have been diagnosed with iron deficiency anemia. The Red Blood Cells are responsible for taking and carrying oxygen to the tissues and organs of the body, which requires the production of hemoglobin in the red blood cells caused by the presence of iron stores in the human body.

What is Accrufer used for?

To treat the symptoms of iron deficiency, Accrufer is a prescribed medicine belonging to the class of drugs called Iron Products, that is used with or without other medications.


Request Sample