Biomaterial Database

Pharmaceutical analysis of the oral iron chelator deferiprone (DMHP,L1). 1996

R Lange, and W Lameijer, and C Slijkhuis, and D de Kaste

Department of Clinical Pharmacy, St. Antonius Zlekenhuis, Nieuwegein, The Netherlands.

The oral iron chelator deferiprone (1,2-dimethyl-3-hydroxy-pyrid-4-one, DMHP, LT or CP20) can be a useful drug in patients with transfusional hemosiderosis. From 1987 about 1000 patients in 16 countries have taken this drug on the base of clinical trials or compassionate use. Since this compound is only available as a raw substance, it is important to ascertain its purity before bringing the drug into a pharmaceutical formulation. Because deferiprone is administered chronically and in high doses, intake of potential toxic impurities can be substantial. In this article a proposal for the quality control of deferiprone is presented in the form of a pharmaceutical monograph. This includes the analytical methods required for identification, purity checking and assay. Furthermore the way we synthesized the drug to get hold of it in a pure form is described. This synthesis is also used in manufacturing the drug commercially. The monograph can be used as a guideline for standardization of the quality of deferiprone to be used for further study and treatment.

UI	MeSH Term	Description	Entries
D007501	Iron	A metallic element with atomic symbol Fe, atomic number 26, and atomic weight 55.85. It is an essential constituent of HEMOGLOBINS; CYTOCHROMES; and IRON-BINDING PROTEINS. It plays a role in cellular redox reactions and in the transport of OXYGEN.	Iron-56,Iron 56
D011728	Pyridones	Pyridine derivatives with one or more keto groups on the ring.	Pyridinones
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D006486	Hemosiderosis	Conditions in which there is a generalized increase in the iron stores of body tissues, particularly of liver and the MONONUCLEAR PHAGOCYTE SYSTEM, without demonstrable tissue damage. The name refers to the presence of stainable iron in the tissue in the form of hemosiderin.	Hemosideroses
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077543	Deferiprone	A pyridone derivative and iron chelator that is used in the treatment of IRON OVERLOAD in patients with THALASSEMIA.	1,2-Dimethyl-3-hydroxy-4-pyridinone,1,2-Dimethyl-3-hydroxypyrid-4-one,1,2-Dimethyl-3-hydroxypyridin-4-one,3-Hydroxy-1,2-dimethyl-4-pyridinone,DMOHPO,Ferriprox,HDMPP,1,2 Dimethyl 3 hydroxy 4 pyridinone,1,2 Dimethyl 3 hydroxypyrid 4 one,1,2 Dimethyl 3 hydroxypyridin 4 one,3 Hydroxy 1,2 dimethyl 4 pyridinone
D000284	Administration, Oral	The giving of drugs, chemicals, or other substances by mouth.	Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations