Claims for Patent: 5,008,388

Summary for Patent: 5,008,388

Title:	Process for preparation of a new hemin complex
Abstract:	The present invention relates to a method for the preparation of a new, physiologically active, water-soluble complex compound, hemin arginate or hemin lysinate. According to the invention crystalline hemin and one of the amino acids L-arginine or L-lysine, in a molar proportion of 1:3, are allowed to react at room temperature under vigorous stirring for 10 to 15 hours in a solvent mixture of acetone and water in a ratio of 300:20 v/v. The hemin arginate or hemin lysinate thus formed is a powdery, stable compound suitable for use as raw material in tablets or capsules or as dry substance for preparation of injections for treatment of various types of anemia, including iron deficiency anemia and anemias and diseases associated with defects in heme synthesis.
Inventor(s):	Ingberg; Grels D. (Ekenas, FI), Penttila; Ritva L. A. (Helsinki, FI), Tokola; Reino O. (Helsinki, FI), Tenhunen; Raimo (Helsinki, FI)
Assignee:	Huhtamaki Oy (Turku, FI)
Application Number:	06/803,630
Patent Claims:	1. A method for preparing a physiologically active, water-soluble complex of hemin and a material selected from the group consisting of L-arginine and L-lysine comprising vigorously stirring a mixture of said hemin and said material selected from the group consisting of L-arginine and L-lysine at room temperature for a period of 10 to 15 hours, the molar ratio of hemin to said material selected from the group consisting of L-arginine and L-lysine being from 1:1 to 1:4, the reaction taking place in a mixture of acetone and water which are in a ratio, on a volume basis, of from 300:10 to 300:25. 2. The method of claim 1 wherein the ratio of acetone and water is 300:20, on a volume basis. 3. The method of claim 1 wherein the molar ratio is approximately 1:3. 4. The method of claim 1 wherein the material complexed with hemin is L-arginine. 5. The method of claim 1 wherein the material complexed with hemin is L-lysine. 6. The method of claim 1 wherein the ratio of acetone to water is approximately 300:20. 7. The method of claim 1 wherein the ratio of acetone and water is 300:20, on a volume basis, and the molar ratio is approximately 1:3.

Details for Patent 5,008,388

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	PANHEMATIN	hemin for injection	For Injection	101246	07/20/1983		2008-04-16