IP Library Patent Application 16142646
Patent Application
App. No. 16/142,646

INTRANASAL ADMINISTRATION

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Quick Facts
Patent No.
US None
App. No.
16/142,646
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.

Claims (43)

1 - 5 . (canceled)

6 . 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 subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

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;

wherein the air exhaled from an exhalation breath is delivered through the nosepiece to entrain the protein formulation as delivered from the nozzle;

wherein the protein formulation comprises a solubilized protein formulation which includes a solubilizing agent which maintains the protein in solution following delivery.

7 . The method of claim 6 , wherein the nosepiece includes an agent which degrades polysaccharide components of endotoxins.

8 . The method of claim 6 , further comprising replacing the nosepiece following each delivery.

9 . The method of claim 6 , wherein the protein does not precipitate from solution owing to one or more of a shift in pH, ionic balance or osmolarity following delivery.

10 . The method of claim 6 , wherein the protein formulation includes an immunomodulator which acts to prevent an immune response to the protein.

11 . The method of claim 6 , wherein the protein is configured to degrade after about 5 minutes following delivery.

12 . The method of claim 11 , wherein the protein formulation includes a proteolytic agent or one or more of trypsin, chymotrypsin, N terminal peptidases or C terminal peptidases which acts to degrade the protein after delivery.

13 . The method of claim 6 , wherein the protein is configured for uptake from the olfactory region in the upper posterior region within about 5 minutes following delivery.

14 . The method of claim 13 , wherein the protein formulation includes an uptake agent or a cyclodextrin for providing for uptake of the protein from the olfactory region.

15 . The method of claim 6 , wherein the protein comprises insulin or an insulin analogue.

16 . The method of claim 6 , wherein the protein comprises an oxytocic hormone, carbetocin, demoxytocin, oxytocin or a pharmaceutically-acceptable derivative or analogue thereof.

17 . The method of claim 6 , wherein the protein comprises an oxytocin antagonist, atosiban or a pharmaceutically-acceptable derivative or analogue thereof.

18 . The method of claim 6 , wherein the protein comprises:

(i) an antidiurectic hormone, argipressin, lypressin, desmopressin, felypressin, ornipressin, terlipressin, vasopressin or a pharmaceutically-acceptable derivative or analogue thereof;

(ii) a corticotrophic hormone, corticotrophin, tetracosactide or a pharmaceutically-acceptable derivative or analogue thereof;

(iii) a corticotrophic releasing hormone, corticorelin or a pharmaceutically-acceptable derivative or analogue thereof;

(iv) an omatotrophic hormone, mecasermin, somtrem, somatropin or a pharmaceutically-acceptable derivative or analogue thereof;

(v) a somatotrophic hormone receptor antagonist, pegvisomant or a pharmaceutically-acceptable derivative or analogue thereof;

(vi) an omatotrophic releasing hormone, sermorelin, somatorelin or a pharmaceutically-acceptable derivative or analogue thereof;

(vii) a somatotrophic release inhibitor, lanreotide, octreotide, somatostatin, vapreotide or a pharmaceutically-acceptable derivative or analogue thereof;

(viii) a gonadotrophic hormone, choriogonadotrophin alfa, chorionic gonadotrophin, a follicle stimulating hormone, follitropin alfa, follitropin beta, a luteinising hormone, lutropin alfa, menotrophin, urofollitropin or a pharmaceutically-acceptable derivative or analogue thereof;

(ix) a gonadotrophic releasing hormone, buserelin, deslorelin, gonadorelin, goserelin, histrelin, leuprorelin, naferlin, triptorelin or a pharmaceutically-acceptable derivative or analogue thereof;

(x) an onadotrophic releasing hormone antagonist, abarelix, cetorelix, ganirelix or a pharmaceutically-acceptable derivative or analogue thereof;

(xi) a thyrotrophic hormone, thyrotrophin, thyrotrophin alfa or a pharmaceutically-acceptable derivative or analogue thereof;

(xii) a thyrotrophic releasing hormone, posatirelin, protirelin, taltirelin or a pharmaceutically-acceptable derivative or analogue thereof;

(xiii) a lactotrophic hormone, prolactin or a pharmaceutically-acceptable derivative or analogue thereof;

(xiv) a metabolic peptide, an insulin-like growth factor, a glucagon, a growth hormone, PYY3-36 or a pharmaceutically-acceptable derivative or analogue thereof;

(xv) a calcitonin, elcatonin, salcatonin or a pharmaceutically-acceptable derivative or analogue thereof;

(xvi) a melanocyte stimulating hormone;

(xvii) a nerve growth factor;

(xviii) an epidermal growth factor;

(xix) an epoetin or a pharmaceutically-acceptable derivative or analogue thereof;

(xx) an interleukin;

(xxi) a protein involved in one or both of blood coagulation and fibrinolysis; or

(xxii) an antibiotic.

19 . The method of claim 6 , wherein the protein is configured to degrade after about 10 minutes following delivery.

20 . The method of claim 6 , wherein the protein is configured to degrade after about 15 minutes following delivery.

21 . The method of claim 6 , wherein the protein is configured for uptake from the olfactory region in the upper posterior region within about 10 minutes following delivery.

Assignments (2)
RELEASE OF SECURITY INTEREST Recorded May 21, 2025
From: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
To: OPTINOSE INC.
Reel/Frame 071547/0979 →
SECURITY INTEREST Recorded Sep 13, 2019
From: OPTINOSE AS
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 050371/0913 →