# US 2014/0193501 A1 · Pulmonary Delivery in Treating Disorders of the Central Nervous System

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- Number: US 2014/0193501 A1
- Document ID: US20140193501A1
- Status: Published application
- Kind: A1
- Application number: 14/152,492
- Filed: 2014-01-10
- Published: 2014-07-10
- Earliest claimed: 2000-09-19
- Assignees: Civitas Therapeutics, Inc.
- Applicants: Civitas Therapeutics, Inc.
- Inventors: Raymond T. Bartus; Dwaine F. Emerich
- Web page: https://patentgrep.com/patent/US20140193501A1

## CPC

- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 9/008: {comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/06: Antimigraine agents
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- 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
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.

## Claims

### Claim 1

A method for delivering a drug to the pulmonary system of a patient comprising, administering a drug selected from a triptan drug to the respiratory tract of the patient in need of the drug, wherein the drug is delivered to the deep lung of the pulmonary system and wherein the drug is delivered in a dose that is therapeutically effective for treating migraines.

### Claim 2 (depends on 1)

The method of claim 1, wherein the dose that is therapeutically effective for treating migraines is at least about two times less than the dose required by oral administration of the drug.

### Claim 3 (depends on 1)

The method of claim 1, wherein the drug is delivered to the pulmonary system in the form of particles.

### Claim 4 (depends on 3)

The method of claim 3, wherein the particles delivered to the pulmonary system have an aerodynamic diameter ranging from about 1 μm to about 5 μm.

### Claim 5 (depends on 3)

The method of claim 3, wherein the particles delivered to the pulmonary system have an aerodynamic diameter in the range from about 1 μm to about 3 μm.

### Claim 6 (depends on 3)

The method of claim 3, wherein the particles deliver at least about 10 milligrams of the drug to the pulmonary system.

### Claim 7 (depends on 1)

The method of claim 1, wherein the drug is delivered to the pulmonary system in a single, breath activated step.

### Claim 8 (depends on 3)

The method of claim 3, wherein the particles consist essentially of the drug.

### Claim 9 (depends on 3)

The method of claim 3, wherein the particles consist of the drug.