Chelon — Technical Documentation

Chelon: A High Compliance Oral Iron for Better Absorption and Gastrointestinal Tolerance

Product Monograph Ferrous Bisglycinate + Vitamin C Version 1.0

Iron deficiency is one of the most common nutritional deficiencies in clinical practice. Iron deficiency can be observed in people of different age groups, including children, adolescents, women in reproductive age, pregnant and lactating women, working adults and people with poor diet or chronic blood loss. Iron deficiency may manifest itself in fatigue, weakness, poor concentration, poor work performance, poor tolerance of physical activity, pallor, hair loss, iron deficiency anaemia. While iron deficiency is a common and manageable problem, successful correction of iron deficiency requires not only prescription of iron, but also patient compliance.

Oral iron is the most commonly used form of iron supplementation. Nevertheless, conventional iron preparations, like ferrous sulphate, ferrous fumarate and ferrous ascorbate, suffer from practical difficulties. Iron salt formulations cause gastric irritation, constipation, nausea, abdominal pain, metallic taste or sensation of heaviness in some people. All these symptoms usually lead to missed doses and early discontinuation of the therapy. Consequently, despite adequate prescription, the patient suffers from iron deficiency.

Key Insight: The efficacy of oral iron therapy depends not just on the dose prescribed, but on the dose absorbed and tolerated. Poor compliance due to gastrointestinal side effects is the primary reason conventional iron therapy fails.

Design Philosophy

Chelon has been designed to solve this problem. Chelon is an oral iron supplement containing 30 mg elemental iron in a form of ferrous bisglycinate along with Vitamin C 65 mg. The concept of Chelon lies in the fact that iron therapy should not only contain a certain amount of iron, but also take into account its absorption, tolerability and compliance. Ferrous bisglycinate is an amino acid chelate iron which is considered to be a high bioavailability iron molecule. In Chelon, iron is bound with glycine which improves iron absorption and reduces exposure of free iron to the gastrointestinal tract.

Ferrous bisglycinate has one more advantage: a relatively low elemental iron dosage can help to achieve effective iron supplementation. In Chelon, the elemental iron dose is 30 mg, not as a high-dose approach, but as an absorption-focused approach. High elemental iron dose will not ensure good results if it is poorly absorbed or if the patient discontinues the tablet due to side effects. Relatively low-dose, well-absorbed and well-tolerated form of iron is more beneficial for patients who require continuing their supplementation. This is especially true as the correction of iron deficiency may take several weeks or months.

Role of Vitamin C

Vitamin C 65 mg in Chelon is aimed at supporting iron absorption. Vitamin C helps to keep iron in the absorptive state and enhances iron absorption in gastrointestinal tract. Thus, Vitamin C plays a complementary role to ferrous bisglycinate and helps to reinforce Chelon positioning as an absorption-focused iron supplement.

Tablet Design & Compliance

Chelon is also positioned as a small-size and easily-consumed tablet. Small tablet may seem a minor issue, but it is a very practical one. Patients who already have a negative association about iron tablets regarding nausea, gastric irritation or constipation may not want to consume a large tablet or capsule. Small-size tablet will be more acceptable and may promote better compliance, especially in those patients who need long-term therapy.

Clinical Applications

The product may be used in a variety of clinical settings when iron supplementation is required. These include:

Iron deficiency in adults
Iron deficiency anaemia under medical recommendation
Iron supplementation during pregnancy under medical supervision
Paediatric use of iron under physician prescription
Iron deficiency-related hair loss

Chelon may be of great help in those cases when the patients discontinued conventional iron because of constipation, gastric irritation, nausea or poor tolerability.

Note: During pregnancy and lactation iron needs increase, but the supplementation should always be done under medical prescription. Chelon may be considered where tolerability is of great importance, but pregnant women should not use several iron-containing products without consultation with a doctor. During childhood, the use of Chelon should be physician-guided, with individualized dose and duration of therapy depending on the child's age, weight, and clinical condition.

Monitoring & Follow-up

Monitoring is always an important aspect of the therapy. Patient's response may be checked using haemoglobin level, full blood count, serum ferritin, transferrin saturation and other necessary examinations. A practical clinical approach includes:

2–3 weeks: Check patient compliance and tolerability
3–6 weeks: Assess haematological response

Replenishment of iron storage may need longer treatment even after the patient feels better or after an increase in haemoglobin level.

Managing Poor Response

If the patient shows poor response to the therapy, the cause should be identified. Poor response can be caused by:

Poor compliance
Menstrual blood loss
Gastrointestinal bleeding
Malabsorption
Inflammation or chronic disease
Co-existing iron deficiency with B12 and folic acid deficiency
Wrong diagnosis or insufficient treatment duration

Thus, therapy failure should not be concluded before checking compliance, tolerability and sources of iron deficiency.

Responsible Marketing & Safety

Chelon should be marketed responsibly. Chelon has been created for improved gastrointestinal tolerability, but it should not be marketed as an iron preparation without any side effects. There are still patients who may experience nausea, abdominal discomfort, constipation, loose stool, dark stool, or metallic taste.

Safety Warning: Iron overdose is dangerous, especially for children. The preparation should be stored safely and away from children. Patients with iron overload diseases, repeated transfusion states, unexplained anaemia, liver disease, active gastrointestinal disease or with suspected bleeding should use iron preparations only under medical supervision.

Conclusion

Summarizing the above, Chelon is a small-size, high-bioavailability iron amino acid chelate with Vitamin C 65 mg, designed for better absorption, improved gastrointestinal tolerability and better patient compliance. The clinical message of Chelon is quite clear: oral iron therapy is effective only when the patient continues it. By using ferrous bisglycinate, Vitamin C, low elemental iron content and a small tablet size, Chelon solves the practical aspects of iron therapy and offers a reasonable choice to patients requiring correction of iron deficiency with better acceptance and compliance.