STUDY OF THE RELEASE KINETICS OF FERRIC FUMARATE FROM A SOLID DOSAGE FORM USING THE IN VITRO METHOD
Keywords:
Iron fumarate, iron deficiency anemia, bioequivalence, solubility, dissolution.Abstract
To study the biopharmaceutical parameters of the recommended pharmaceutical composition with antianemic action, containing ferrous fumarate.
References
Vetchý D, Frýbortová K, Rabisková M, Danecková H. Bioequivalence studies of pharmaceutical preparations. Cas Lek Cesk (2007) 146(5):431–3.
FDA. Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products – General Considerations. Center for Drug Evaluation and Research, the US Food and Drug Administration; Rockville, Maryland, USA: 2003.
Baker RD, Greer FR Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age) // Pediatrics. - 2010. - Vol. 126, N5.-P. 1040-1050.
Burton JK, Yates LC New horizons in iron deficiency anemia in older adults. // Age and Aging. – 2020.
Camaschella C. Iron deficiency. Blood. 2019;133:30 –9. Doi: 10.1182/blood-2018-05-815944.
Chapman Hall/CRC Press, Taylor& Francis; New York, New York, USA: 2008.
Chow, SC.; Liu, JP. Design and Analysis of Bioavailability and Bioequivalence Studies.
FDA. Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products – General Considerations. Center for Drug Evaluation and Research, the US Food and Drug Administration; Rockville, Maryland, USA: 2003.
FIP Guidelines for Dissolution Testing of Solid Oral Products. Dissolution Technol 1997; 4:5–14.
Garrick MD, Garrick LM. Cellular iron transport // Biochim Biophys Acta. 2009; 1790: 309–325. http://dx.doi.org/10.1016/j.bbagen.2009.03.018 .
Giblin TJ Jr, Lee JF, Rattigan JP. Ferrous fumarate: a well tolerated oral iron preparation. Clin Med (Northfield) 1962; 69:2258–2260.
Global Health Metrics. Anemia-Level 1 impairment. Lancet. 2019;393 [https://www.healthdata.org/results/gbd_summaries/2019/anemia-level-1-impairment].
Guidance for Industry. Immediate Release Solid Oral Dosage Forms. ScaleUp and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. September 1997.
Haidar SH, Davit BM, Chen ML, et al. Bioequivalence approaches for highly variable drugs and drug products. Pharmaceutical Research. 2008; 25:237–241. [PubMed: 17891552].
Hurrell, R. Use of ferrous fumarate to fortify foods for infants and young children / R. Hurrell // Nutr. Rev. – 2010. – No. 68 (9). – R. 522–530.
Iron deficiency anemia: assessment, prevention, and control. A guide for program managers. UNICEF, United Nations University, WHO. Geneva: World Health Organization, 2001.
Johnson-Wimbley TD, Graham DY. Diagnosis and management of iron deficiency anemia in the 21st century. Ther Adv Gastroenterol 2011; 4 (3): 177–84.
Liu, T.C. Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: A Taiwanese study [Text] / T.C. Liu, S.F. Lin, C.S. Chang, W.C. Yang, T. P. Chen / / International Journal of Hematology. – 2004. – Vol. 80, Issue 5. – P. 416–420.
Maureen M. Okam , Todd A. Koch, b Minh-Ha Tran. Iron Supplementation, Response in Iron-Deficiency Anemia: Analysis of Five Trials // The American Journal of Medicine, Vol 130, No 8, August 2017; 130:991.e 1-991.e8. https://doi.org/10.1016/j.amjmed.2017.03.045 .
Panakanti R, Narang AS. Impact of excipient interactions on drug bioavailability from solid dosage forms // Pharm Res. 2012; 29:2639–2659. http://dx.doi.org/10.1007/s11095-012-0767-8 .130. Recommendations on dissolution testing. PHARMEUROPA 2008;20(3):525–527.
Reddy K, Karunakar A. Biopharmaceutics classification system: a regulatory approach. Dissolution Technol 2011; February:31–3.
State Pharmacopoeia of the Republic of Uzbekistan. First edition. Volume 1, 1-2 parts.
Tomasevic R., Gluvic Z., Mijac D. et al. Anemia as a problem: GEH approach. Dig Dis 2022;40(2):133–41. DOI: 10.1159/000516480.
Vetchý D, Frýbortová K, Rabisková M, Danecková H. Bioequivalence studies of pharmaceutical preparations. Cas Lek Cesk (2007) 146(5):431–3.
World Health Organization. Weekly iron and folic acid supplementation as an anemia -prevention strategy in women and adolescent girls [Text]/World Health Organization 2018 // WHO. – 2018. – P.1– 40.
