Claims for Patent: 10,112,021

Summary for Patent: 10,112,021

Title:	Intranasal administration
Abstract:	Intranasal administration of proteins, such as insulin and insulin analogues, in particular immunogenic proteins to the upper posterior region of a nasal cavity of a subject, and in particular the olfactory bulb region.
Inventor(s):	Hafner; Roderick Peter (Wiltshire, GB)
Assignee:	OptiNose AS (Oslo, NO)
Application Number:	14/635,561
Patent Claims:	1. A method of delivering a protein formulation to the upper posterior region of a nasal cavity of a subject for uptake into the central nervous system (CNS) of the subject, the method comprising the steps of: delivering the formulation through a nozzle of a nosepiece of a delivery device into the nasal cavity of the subject to provide for uptake of the protein to the CNS without triggering an immune response; and the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; wherein air exhaled from an exhalation breath is delivered through the nosepiece to entrain the protein formulation as delivered from the nozzle; and wherein the nosepiece includes a coating which prevents the accumulation of endotoxins thereon. 2. The method of claim 1, wherein the protein comprises a corticotrophic releasing hormone. 3. The method of claim 2, wherein the corticotrophic releasing hormone is corticorelin. 4. The method of claim 1, wherein the protein comprises a somatotrophic hormone receptor antagonist. 5. The method of claim 4, wherein the somatotrophic hormone receptor antagonist is pegvisomant. 6. The method of claim 1, wherein the protein comprises insulin or an insulin analogue. 7. The method of claim 1, wherein the coating degrades endotoxin polysaccharides. 8. The method of claim 1, wherein the nosepiece is replaceable. 9. The method of claim 1, wherein the delivery device further comprises an outer sleeve that covers the nosepiece. 10. The method of claim 9, wherein the outer sleeve includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 11. The method of claim 10, wherein the indicator material of the outer sleeve indicates exposure to endotoxins. 12. The method of claim 1, wherein the delivery device further comprises a plurality of removable outer sleeves, each of the plurality of outer sleeves configured to cover the nosepiece. 13. The method of claim 12, wherein each of the plurality of removable outer sleeves includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 14. The method of claim 1, wherein the nosepiece includes an anti-bacterial coating which degrades endotoxin polysaccharides. 15. A method of delivering a protein formulation to the upper posterior region of a nasal cavity of a subject for uptake into the CNS of the subject, the method comprising the steps of: delivering the formulation through a nozzle of a nosepiece of a delivery device into the nasal cavity of the subject to provide for uptake of the protein to the CNS without triggering an immune response; and delivering a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, to the nosepiece to entrain the protein formulation as delivered from the nozzle; and wherein the nosepiece includes a coating which prevents the accumulation of endotoxins thereon. 16. The method of claim 15, wherein the protein comprises insulin or an insulin analogue. 17. The method of claim 15, wherein the coating degrades endotoxin polysaccharides. 18. The method of claim 15, wherein the nosepiece is replaceable. 19. The method of claim 15, wherein the delivery device further comprises an outer sleeve that covers the nosepiece. 20. The method of claim 13, wherein the outer sleeve includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 21. The method of claim 20, wherein the indicator material of the outer sleeve indicates exposure to endotoxins. 22. The method of claim 15, wherein the delivery device further comprises a plurality of removable outer sleeves, each of the plurality of outer sleeves configured to cover the nosepiece. 23. The method of claim 16, wherein each of the plurality of removable outer sleeves includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 24. The method of claim 15, wherein the nosepiece includes an anti-bacterial coating which degrades endotoxin polysaccharides. 25. A method of delivering insulin or an insulin analogue to a subject, the method comprising: delivering a therapeutically effective amount of a formulation consisting essentially of insulin or an insulin analogue in solubilized or power form through a nozzle of a nosepiece of a delivery device to the olfactory bulb in the upper posterior region of a nasal cavity of the subject for uptake of the insulin or insulin analogue into the central nervous system of the subject without triggering an immune response; and causing the subject to exhale through a mouthpiece unit of the delivery device to cause closure of the oropharyngeal velum of the subject; wherein air exhaled from an exhalation breath of the subject is delivered through the nosepiece to entrain the formulation as delivered from the nozzle; and wherein the nosepiece includes a coating which prevents the accumulation of endotoxins thereon. 26. The method of claim 25, wherein the delivery of the formulation is under conditions that avoid presentation to nasal associated lymphatic tissue (NALT), adenoids, antigen presenting cells (APCs), and nasal mucosa. 27. The method of claim 25, wherein the coating degrades endotoxin polysaccharides. 28. The method of claim 25, wherein the nosepiece is replaceable. 29. The method of claim 25, wherein the delivery device further comprises an outer sleeve that covers the nosepiece. 30. The method of claim 29, wherein the outer sleeve includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 31. The method of claim 30, wherein the indicator material of the outer sleeve indicates exposure to endotoxins. 32. The method of claim 25, wherein the delivery device further comprises a plurality of removable outer sleeves, each of the plurality of outer sleeves configured to cover the nosepiece. 33. The method of claim 32, wherein each of the plurality of removable outer sleeves includes an indicator material which indicates exposure to one or more of moisture and biomaterials. 34. The method of claim 25, wherein the nosepiece includes an anti-bacterial coating which degrades endotoxin polysaccharides.

Details for Patent 10,112,021

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	March 25, 2003	10,112,021	2035-03-02
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	July 31, 2014	10,112,021	2035-03-02