Claims for Patent: 6,245,740

Summary for Patent: 6,245,740

Title:	Polyol:oil suspensions for the sustained release of proteins
Abstract:	The present invention relates to the preparation of polyol/thickened oil suspensions containing a biologically active agent, for the sustained delivery of the biologically active agent. The described protein/glycerol/oil suspensions show sustained release of protein, e.g., G-CSF, of up to at least one week.
Inventor(s):	Goldenberg; Merrill (Thousand Oaks, CA), Shan; Daxian (Thousand Oaks, CA), Beekman; Alice (Thousand Oaks, CA)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	09/221,181
Patent Claims:	1. A sustained-release pharmaceutical composition comprising granulocyte-colony stimulating factor (G-CSF) incorporated into a biocompatible polyol:oil suspension, wherein said suspension contains a thickener, and wherein said composition is prepared by a process which comprises: (a) suspending G-CSF powder in a polyol to form a G-CSF:polyol mixture; (b) suspending said G-CSF:polyol mixture in a mixture comprising a thickened oil to form a G-CSF:polyol:oil suspension; wherein the level of said polyol in said suspension is in the range from 15%-30% by weight. 2. The composition of claim 1 wherein said biocompatible polyol is selected from the group consisting of glycerol, erythritol, arabinose, xylose, ribose, inositol, fructose, galactose, maltose, and sucrose. 3. The composition of claim 1 wherein the thickener is selected from the group consisting of polyvalent metal salts of organic acids waxes and high viscosity oils. 4. The composition of claim 3 wherein the thickener is aluminum monostearate. 5. The composition of claim 3 wherein the thickener is white wax. 6. The composition of claim 1 wherein said oil is selected from the group consisting of sesame, castor, cottonseed, cannola, saffron, olive, peanut, sunflower seed, .alpha.-tocopherol, and ethyl oleate. 7. A process for preparing sustained-release pharmaceutical compositions of G-CSF:polyol:oil suspensions which comprises: (a) suspending G-CSF powder in a polyol to form a G-CSF:polyol mixture; (b) suspending said G-CSF:polyol mixture in a mixture comprising a thickened oil to form a G-CSF:polyol:oil suspension; wherein the level of said polyol in said suspension is in the range from 15%-30% by weight. 8. A method for the parenteral administration of G-CSF:polyol:oil suspension to a warm blooded animal, wherein said suspension is administered subcutaneously, or intramuscularly and the G-CSF is released from theto said animal suspension at a controlled rate for up to one week or more.

Details for Patent 6,245,740

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	March 25, 2003		2018-12-23
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	July 31, 2014		2018-12-23
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020		2018-12-23