Claims for Patent: 9,486,531

Summary for Patent: 9,486,531

Title:	Dehydrated hydrogel inclusion complex of a bioactive agent with flowable drug delivery system
Abstract:	The invention provides a controlled release biodegradable polymer formulation adapted for administering bioactive agents such as therapeutic proteins to a patient through implantation of a bolus that forms a depot within the patient\'s body tissues. The formulation includes a dehydrated inclusion complex of the bioactive agent within a hydrogel, wherein the hydrogel can comprise a polymerized polyalkyleneglycolyl diacrylate, and, optionally, polyalkyleneglycolyl monoacrylates, including methacrylates. Alternatively, the hydrogel can comprise hyaluronic acid, chitosan, agarose, polyvinylacetate, polyvinylpyrrolide, or polyvinylalcohol nanoparticles. The bioactive agent can be a macromolecular material, such as a protein. A method of forming the inventive formulation is also provided, as well as a method for using the formulation in the treatment of a malcondition in a patient in need thereof.
Inventor(s):	Dadey; Eric (Furlong, PA), Watkins; Andrew (Drew) (Fort Collins, CO)
Assignee:	INDIVIOR UK LIMITED (Slough, GB)
Application Number:	12/995,956
Patent Claims:	1. A formulation comprising a dehydrated inclusion complex dispersed in a solution; wherein the dehydrated inclusion complex comprises a protein stabilized within a hydrogel; wherein the hydrogel comprises a polymerized polyethyleneglycolyl dimethacrylate having a molecular weight from about 500 Daltons to about 10,000 Daltons, and wherein the solution consists of: (i) a poly(lactide-glycolide) copolymer, and (ii) N-methylpyrrolidone, dimethylacetamide, dimethylformamide, dimethylsulfoxide, a polyethyleneglycol, or a combination of two or more thereof. 2. The formulation of claim 1, wherein the polyalkyleneglycol diacrylate has a molecular weight of about 750 Daltons to about 2,000 Daltons. 3. The formulation of claim 1, wherein the protein is a monoclonal antibody. 4. The formulation of claim 1, wherein the protein is insulin, human growth hormone, cetuximab, or bevacizumab. 5. The formulation of claim 1, wherein the hydrogel particles are present in a concentration of about 5 wt % to about 50 wt %. 6. A formulation comprising: (i) a dehydrated inclusion complex comprising a protein stabilized within a hydrogel; wherein the hydrogel comprises a polyalkyleneglycol diacrylate; (ii) a biodegradable polymer consisting of a poly(lactide-glycolide) copolymer; and (iii) N-methylpyrrolidone, dimethylacetamide, dimethylformamide, dimethylsulfoxide, a polyethyleneglycol, or a combination of two or more thereof. 7. The formulation of claim 6, wherein the polyalkyleneglycol diacrylate has a molecular weight of about 500 Daltons to about 10,000 Daltons. 8. The formulation of claim 6, wherein the polyalkyleneglycol diacrylate is a polyalkyleneglycolyl dimethacrylate. 9. The formulation of claim 6, wherein the polyalkyleneglycolyl diacrylate is a polyethyleneglycolyl dimethacrylate. 10. The formulation of claim 6, wherein the protein is insulin, human growth hormone, cetuximab, or bevacizumab. 11. The formulation of claim 6, wherein the protein is a monoclonal antibody.

Details for Patent 9,486,531

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2028-06-03
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2028-06-03
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2028-06-03
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2028-06-03