Iron deficiency is frequently encountered in chronic kidney disease (CKD) patients and many other populations. Current oral iron formulations are poorly tolerated. Injectable iron preparations are difficult to administer, costly and have serious adverse reactions. Therefore, a highly absorbable, well tolerated oral iron supplement for the treatment of anemia associated with chronic kidney disease (CKD) is needed to complement erythropoiesis-stimulating agents. Our iron replacement agent will have the following attributes: 1) oral delivery with minimal adverse events, 2) efficient intestinal transit with vascular system entry, 3) liver targeting where the iron is released to normal iron stores and 4) cost-effective manufacture providing savings to the medical economy. Our Phase I SBIR application is designed to synthesize prototype products fitting this description. This will be accomplished by applying the company's nano-technology expertise to develop a stable iron oxide colloid having a surface coating to permit intestinal transport while protecting against bacterial bloom within th gut. Our proposed product is expected to be the first commercially feasible oral iron replacement therapy that can be safely self-administrated by the patient.
Public Health Relevance Statement: Public Health Relevance: This project will develop an oral iron supplement to more effectively treat iron deficient patients, a common occurrence in chronic kidney disease. The advantage of this product will be its low cost and the easy-of-use. This product is expected to be the first commercially feasible method that will allow patients to self-treat iron deficiency.
NIH Spending Category: Bioengineering; Biotechnology; Digestive Diseases; Hematology; Kidney Disease; Nanotechnology; Nutrition
Project Terms: Adverse event; Adverse reactions; Albumins; Amino Acids; Anemia; Animals; arabinogalactan; Biochemical; Biotin; Caco-2 Cells; Cell Culture Techniques; cell type; cellular microvillus; Centers for Disease Control and Prevention (U.S.); Characteristics; Charge; Chemicals; Cholic Acids; Chronic Kidney Failure; Colloids; Complement; cost; cost effective; design; dextran; Dextrans; Dialysis procedure; Disease Outcome; Distress; Dose; Drug Formulations; Enterocytes; Erythropoiesis; experience; Fatty Acids; ferric gluconate; Ferumoxytol; Folate; Foundations; Gastrointestinal Transit; Glycoproteins; Growth; Guidelines; Health Personnel; Hemin; Hemoglobin; Hospitals; hydrophilicity; Hydrophobicity; Hydroxyl Radical; improved; indexing; Injectable; inorganic phosphate; Intestinal Absorption; Intestines; Intravenous; Inulin; Iron; iron deficiency; Iron deficiency anemia; iron oxide; iron supplement; iron supplementation; Iron-Dextran Complex; Kidney; Kidney Diseases; Lead; Length; Liver; Malnutrition; Mannans; Marketing; Medical; Methods; Molecular Weight; Monitor; monolayer; nanoparticle; Nanotechnology; oncology; Oral; Oral Administration; Patients; Peptides; Pharmaceutical Preparations; Phase; phase 1 study; phase 2 study; Polysaccharides; Population; Preparation; prototype; public health relevance; Pyridoxal; Pyridoxal Phosphate; Qualifying; Replacement Therapy; saccharated ferric oxide; Savings; Serum; Small Business Innovation Research Grant; Stomach; success; Surface; surface coating; System; Testing; Tight Junctions; Toxic effect; United States; uptake; Vascular System; Venipunctures; Visit; Vitamin B 12
