Pharmaceutical compositions for intranasal administration for the treatment of neurodegenerative disorders

• US 8,987,199 B2
• Filed: 06/15/2012
• Issued: 03/24/2015
• Est. Priority Date: 06/15/2011
• Status: Active Grant

• Current Assignee: Nerve Access Incorporated
• Original Assignee: Nerve Access Incorporated
• Inventors: Abdel Maksoud, Yaser A., Maher, Mustafa A.
• Primary Examiner(s): Skowronek, Karlheinz R
• Assistant Examiner(s): MADER, CATHERINE J
• Application Number:
  US13/525,176
• Publication Number:
  US 20120322727A1
• Time in Patent Office: 1,012 Days
• Field of Search: 514/6.5
• US Class Current: 514/6.5
• 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 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

In one embodiment of the invention, a pharmaceutical composition for intranasal administration comprises insulin, dimethyl sulfoxide and at least one pharmaceutically acceptable excipient. In another embodiment of the invention, a pharmaceutical composition for intranasal administration comprises clioquinol, dimethyl sulfoxide and at least one pharmaceutically acceptable excipient. In yet another embodiment of the invention, a pharmaceutical composition for intranasal administration comprises insulin, clioquinol, dimethyl sulfoxide and at least one pharmaceutically acceptable excipient. The pharmaceutical compositions of the invention may be used to treat or prevent a neurodegenerative disorder such as Alzheimer'"'"'s disease, stroke, Parkinson'"'"'s disease, multiple sclerosis, spinal cord injuries, and/or traumatic brain injuries and the like, in addition to other systemic and local diseases.

Claims

1. A pharmaceutical composition for intranasal administration consisting of:

insulin present in an amount from about 400 IU/mL to about 600 IU/mL;

dimethyl sulfoxide present in an amount from about 24% (v/v) to about 36% (v/v);

polyethylene glycol present in an amount from about 1.6% (v/v) to about 2.4% (v/v);

glycerin present in an amount from about 1.2% (v/v) to about 1.8% (v/v);

phenol present in an amount from about 0.05% (v/v) to about 0.15% (v/v);

and water in a quantity sufficient to reach final volume.

2. The composition of claim 1, consisting of about 500 IU/mL insulin, about 30% (v/v) dimethyl sulfoxide, about 2% (v/v) polyethylene glycol, about 1.5% (v/v) glycerin, about 0.1% (v/v) phenol;

and water in a quantity sufficient to reach final volume.

3. A method of treating a neurodegenerative disorder in a patient, comprising intranasally administering the composition of claim 1 to the patient.