Ferric Citrate Oral Formulation for Anemia Treatment
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Solution Overview
Problem
Current treatments for iron-deficiency anemia, such as oral and intravenous iron supplements, often come with adverse side effects and are not readily accessible due to equipment limitations, and erythropoiesis-stimulating agents pose safety risks and worsen iron depletion.
Innovation Solution
Administering ferric citrate orally at specific doses and frequencies, monitoring iron storage parameters, and adjusting dosing based on patient response to maintain optimal iron levels without food, thereby reducing the need for intravenous iron and erythropoiesis-stimulating agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oral iron supplements are administered to treat iron-deficiency anemia, then iron deficiency is corrected, but adverse side effects occur leading to patient non-compliance
Solution Approach 1:
The patent changes the chemical form of iron from conventional salts (sulfate, gluconate) to ferric citrate, and administers it in a controlled-release formulation. This parameter change in chemical composition and delivery mechanism reduces gastrointestinal side effects while maintaining iron supplementation effectiveness, directly resolving the contradiction between treatment reliability and harmful factors.
2Reliability
If intravenous iron supplementation is used to treat iron-deficiency anemia, then iron deficiency is corrected, but the treatment requires specialized equipment and is not readily accessible
Solution Approach 1:
The patent replaces the mechanical/invasive intravenous administration system with an oral pharmaceutical composition. This substitution eliminates the need for needles, infusion equipment, and specialized medical facilities, making iron supplementation accessible in primary care settings while maintaining treatment effectiveness through the controlled-release ferric citrate formulation.
3Reliability
If erythropoiesis-stimulating agents are administered to treat anemia, then hemoglobin production is stimulated, but iron depletion worsens and safety risks increase
Solution Approach 1:
The patent introduces ferric citrate as an intermediary substance that provides iron in a form that supports erythropoiesis without the harmful effects of ESA agents. The controlled-release formulation acts as a mediator that gradually supplies iron to support hemoglobin production while avoiding the iron depletion and safety risks associated with ESA therapy, particularly in CKD patients.
Data Source
AI summary
Described herein are methods fir treating patients with iron-deficiency anemia (IDA), comprising administering ferric citrate to such patients. In certain aspects, the patients treated for iron-deficiency anemia have a gastrointestinal disorder, such as inflammatory bowel disease, inflammatory bowel syndrome, Crohn's disease, microscopic colitis (such as collagenous or lymphocytic colitis), or chemically-induced colitis (e.g., NSAID (nonsteroidal anti-inflammatory drug)-induced colitis). In certain aspects, the patients treated for iron-deficiency anemia have blood loss associated with childbirth, menstruation or infection. In some aspects, the patients treated for iron-deficiency anemia have insufficient dietary intake of iron and/or insufficient absorption of iron.