INTRANASAL ADMINISTRATION OF PHARMACEUTICAL AGENTS FOR TREATMENT OF NEUROLOGICAL DISEASES

• US 20140100282A1
• Filed: 10/10/2013
• Published: 04/10/2014
• Est. Priority Date: 10/10/2012
• Status: Abandoned Application

• Current Assignee: Patrick S.L. Wong
• Original Assignee: Patrick S.L. Wong
• Inventors: Wong, Patrick S L
• Application Number:
  US14/051,344
• Publication Number:
  US 20140100282A1
• Time in Patent Office: Days
• US Class Current: 514/561
• 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 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0043 Nose

Abstract

Pharmaceutical formulations for treating neurological diseases are described, wherein the formulations comprise a pharmaceutically active agent-transport moiety complex. The formulations are suitable for administration via an intranasal route. Neurological diseases and conditions are associated with reduced brain insulin signaling (i.e., CNS insulin insensitivity), reduced dopaminergic signaling, reduced serotonergic signaling, reduced cholinergic signaling, or reduced GABAergic signaling, and include Alzheimer'"'"'s disease, Parkinson'"'"'s disease, epilepsy, neuropathic pain, fibromyalgia, post-herpetic neuralgia, insomnia, or anxiety. Neurological diseases also include cancers of the central nervous system (CNS).

Claims

1. A pharmaceutical formulation for treating neurological diseases comprising a pharmaceutically active agent-transport moiety complex and a pharmaceutically acceptable carrier, wherein said formulation is suitable for administration via an intranasal route.

2. The formulation of claim 1, wherein the pharmaceutically active agent is a neurotransmitter or neurotransmitter analog.

3. The formulation of claim 2, wherein the pharmaceutically active agent is gabapentin, pregabalin, or atagabalin.

4. The formulation of claim 2, wherein the pharmaceutically active agent is dopamine.

5. The formulation of claim 1, wherein the pharmaceutically active agent is an anti-hyperglycemic agent.

6. The formulation of claim 5, wherein the pharmaceutically active agent comprises a guanidinium moiety.

7. The formulation of claim 6, wherein the pharmaceutically active agent is selected from metformin, phenformin, buformin, or homologs or derivatives thereof.

8. The formulation of claim 1, wherein the transport moiety is a fatty acid.

9. The formulation of claim 8, wherein the transport moiety is a fatty acid having a branched or straight chain alkyl or alkenyl group comprising 5 to 23 carbon atoms, or mixtures thereof.

10. The formulation of claim 8, wherein the transport moiety is selected from caprylic acid, lauric acid, oleic acid, linoleic acid, or arachidonic acid, or mixtures thereof.

11. The formulation of claim 1, wherein the formulation is in the form of a cream, liquid, spray, powder, or suppository.

12. The formulation of claim 11, wherein the formulation comprises a biocompatible adhesive.

13. The formulation of claim 1, wherein the pharmaceutically active agent-transport moiety complex is characterized by a tight ion-pair bond.

14. The formulation of claim 1, wherein the pharmaceutically active agent-transport moiety complex is characterized by a loose ion-pair bond.

21. The method of claim 1, further comprising administering the formulation of claim 1 on a prescribed schedule.

15. A method for treating a neurological disease comprising intranasally administering a pharmaceutical formulation comprising a pharmaceutically active agent-transport moiety complex.

16. The method of claim 15, wherein the neurological disease is associated with reduced brain insulin signaling, reduced dopaminergic signaling, reduced serotonergic signaling, reduced cholinergic signaling, reduced GABAergic signaling.

17. The method of claim 15, wherein the pharmaceutically active agent is an anti-hyperglycemic agent.

18. The method of claim 15, wherein the pharmaceutically active agent comprises a guanidinium moiety.

19. The method of claim 18, wherein the pharmaceutically active agent is selected from metformin, phenformin, buformin, or homologs or derivatives thereof.

20. The method of claim 15, wherein the neurological disease is Alzheimer'"'"'s disease, Parkinson'"'"'s disease, epilepsy, neuropathic pain, fibromyalgia, post-herpetic neuralgia, insomnia, or anxiety.

22. The method of claim 15, wherein the pharmaceutically active agent is gabapentin.

23. A method for treating a neurological disease comprising intranasally administering a pharmaceutical formulation comprising a dopamine-transport moiety complex.

24. The method of claim 23, wherein the pharmaceutical formulation further comprises an anti-hyperglycemic agent-transport moiety complex.