Non-sedating antihistamine injection formulations and methods of use thereof

• US 9,161,902 B2
• Filed: 07/12/2013
• Issued: 10/20/2015
• Est. Priority Date: 07/03/2009
• Status: Active Grant

• Current Assignee: JDP Therapeutics, LLC
• Original Assignee: JDP Therapeutics, Inc.
• Inventors: Du, Jie
• Primary Examiner(s): RICCI, CRAIG D
• Application Number:
  US13/940,747
• Publication Number:
  US 20130296829A1
• Time in Patent Office: 830 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/341 not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4545 containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

Described herein are automatic injectors suitable for administration of a non-sedating antihistamine, and methods of using the automatic injectors. A specific non-sedating antihistamine is cetirizine. The automatic injectors are useful in treating acute urticaria or angioedema associated with an acute allergic reaction including anaphylaxis.

Claims

1. A method of treating acute urticaria or angioedema associated with an acute allergic reaction in an individual in need thereof, comprising

self-administering from an automatic injector a pre-measured dose of a composition comprising a non-sedating antihistamine either subcutaneously or intramuscularly,

wherein the automatic injector comprises a housing comprising a chamber for the non-sedating antihistamine composition and a dispensing assembly in communication with the chamber, and wherein the dispensing assembly provides for self-administration of the pre-measured dose of the non-sedating antihistamine composition subcutaneously or intramuscularly,

wherein the non-sedating antihistamine is cetirizine, levocetirizine, or a salt thereof.

2. The method of claim 1, wherein the non-sedating antihistamine composition comprises a pH adjusting agent and has a pH of 3 to 9.

3. The method of claim 1, wherein the non-sedating antihistamine is cetirizine or a salt thereof.

4. The method of claim 1, wherein the non-sedating antihistamine composition further comprises ranitidine, cimetidine, epinephrine, methylprednisolone, prednisolone, or a combination thereof.

5. The method of claim 1, further comprising self-administering from a second automatic injector an epinephrine composition, wherein the second automatic injector comprises a second housing comprising a second chamber for the epinephrine composition and a second dispensing assembly in communication with the second chamber.

6. The method of claim 1, wherein treating is in an emergency situation.

7. The method of claim 1, wherein self-administering the non-sedating antihistamine from the automatic injector is non-cardiotoxic and non-sedating.

8. The method of claim 1, wherein the acute allergic reaction includes anaphylaxis.