Claims for Patent: 8,633,152

Summary for Patent: 8,633,152

Title:	Process for making micro-sized protein particles
Abstract:	A process of making micro-sized protein particles comprising the step of drying nano-sized protein particles suspended in a liquid medium under conditions to agglomerate the nano-sized protein particles and thereby form micro-sized protein particles.
Inventor(s):	Glover; William John (Singapore, SG), Wan; Elsa (Singapore, SG), Yun; Jimmy Sunglai (Faber Heights, SG), Chen; Jianfeng (Beijing, CN)
Assignee:	Nanomaterials Technology Pte Ltd (Singapore, SG)
Application Number:	12/672,384
Patent Claims:	1. A process of making micro-sized protein particles comprising the steps of: precipitating nano-sized protein particles from a precipitant solution under conditions to form a suspension of nano-sized protein particles in a liquid medium, said nano-sized protein particles having a narrow particle size distribution with a span value of less than 3; and spray-drying the nano-sized protein particles suspension under conditions to agglomerate the nano-sized protein particles and thereby form micro-sized protein particles having a porous structure, wherein the micro-sized protein particles are suitable for use as a formulation for pulmonary delivery. 2. The process of making micro-sized protein particles as claimed in claim 1, wherein said precipitating step comprises the step of micro-mixing a precipitant solution and an anti-solvent. 3. The process of making micro-sized protein particles as claimed in claim 1, wherein said protein is selected from the group consisting of insulin, albumin, parathyroid hormone, gonadotropin-releasing hormone, DNAse, cyclosporin, immunoglobulin, erythropoietin, interferon, colony stimulating factor, growth hormone, luteinising-hormone releasing hormone (LHRH) analog, LHRH antagonist, tissue plasminogen activator, somatostatin analog, r Factor VIII, r Factor IX, calcitonin, abciximab, dornase alfa, bone inducing protein, bone morphogenic protein, brain derived growth factor, gastrin 17 immunogen, interleukins, polymerase enhancing factor superoxide, chimeric monoclonal antibody, permeability increasing protein-21, platelet derived growth factor, stem cell factor, recombinant human thyrotropin alfa, somatomedin C and mixtures thereof. 4. The process of making micro-sized protein particles as claimed in claim 1, wherein said suspended nano-sized protein particles in said liquid medium is atomized to form droplets during said spray-drying step. 5. The process of making micro-sized protein particles as claimed in claim 4, wherein the time taken to dry said droplet is less than 10 seconds. 6. The process of making micro-sized protein particles as claimed in claim 1, wherein said suspended nano-sized protein particles have a % solids concentration in the range of 0.1% to 10% in said liquid medium. 7. The process of making micro-sized protein particles as claimed in claim 1, wherein the temperature of said suspended nano-sized protein particles is in the range of 4.degree. C. to 40.degree. C. 8. The process of making micro-sized protein particles as claimed in claim 1, wherein said nano-sized protein particles have a particle size in the range of 50 nm to 500 nm. 9. The process of making micro-sized protein particles as claimed in claim 2, wherein said micro-mixing is undertaken under high shear conditions. 10. The process of making micro-sized protein particles as claimed in claim 9, wherein said high shear condition is characterized by a Reynold's number in the range of 2000 to 200,000. 11. The process of making micro-sized protein particles as claimed in claim 1, wherein said spray-drying step is undertaken without the use of a binder to agglomerate said nano-sized protein particles. 12. The process of making micro-sized protein particles as claimed in claim 1, wherein said protein is biologically active to a target. 13. The process of making micro-sized protein particles as claimed in claim 12, wherein said spray-drying does not substantially degrade the biologically activity of said protein. 14. The process of making micro-sized protein particles as claimed in claim 12, further comprising a protein that is not biologically active to a target. 15. A micro-sized protein particle having a porous structure and comprised of a plurality of agglomerated nano-sized protein particles, said nano-sized protein particles having a narrow particle size distribution with a span value of less than 3, wherein the micro-sized protein particle is suitable for use as a formulation for pulmonary delivery. 16. The micro-sized protein particle as claimed in claim 15, wherein said micro-sized protein particle has a particle size in the range from 1 .mu.m to 10 .mu.m. 17. The micro-sized protein particle as claimed in claim 15, wherein said micro-sized protein particle has a substantially spherical shape. 18. The micro-sized protein particle as claimed in claim 15, wherein the porosity of said micro-sized protein particle is in the range of 10% to 80%. 19. The micro-sized protein particle as claimed in claim 15, wherein said micro-sized protein particle has a porous inner core. 20. The micro-sized protein particle as claimed in claim 15, wherein said micro-sized protein particle has a void in the inner core.

Details for Patent 8,633,152

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	11/30/1998		2039-03-29
Genentech, Inc.	PULMOZYME	dornase alfa	Solution	103532	12/30/1993		2039-03-29
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	12/22/1994		2039-03-29