IP Library Granted Patent US 11,364,225
Granted Patent B2
US 11,364,225 · App. 16/854,426 · Granted Jun 21, 2022

Pharmaceutical formulation for treating symptoms of migraine and cluster headaches, and method of using the same

Inventors: Donald M. Pell (St. Petersburg, FL); Paula Pell (St. Petersburg, FL); Michael Spuza (St. Petersburg, FL); Govindan Nair (Seminole, FL)
Assignee: BN INTELLECTUAL PROPERTIES, INC.
A61K31/4045A61K9/0078A61M11/005A61M15/0085A61P25/06A61B5/4824
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Quick Facts
Patent No.
US 11,364,225
App. No.
16/854,426
Granted
Jun 21, 2022
Kind
B2
Abstract

A treatment for symptoms of migraine and cluster headaches includes operations of providing a solution of a serotonin receptor agonist (SRA) in an active mesh nebulizer, triggering the formation of a plume of particles from the active mesh nebulizer, and delivery of the plume of particles into the lungs of a patient during an inhalation process.

Claims (39)

1. A method of treating symptoms of migraine headache or cluster headache, comprising:

providing a solution in an active mesh nebulizer, the solution having

at least 99% by weight of water, and

a serotonin receptor agonist (SRA);

receiving, in a processor of the active mesh nebulizer, information regarding a prescribed dose of the SRA;

calculating instructions for how to deliver the prescribed dose of the SRA based on a delivery rate of the SRA through an active mesh of the active mesh nebulizer, and the prescribed dose of the SRA;

generating at least one plume of particles of the solution having the SRA using the active mesh nebulizer, wherein generating the plume of particles is based on the instructions provided by the processor of the active mesh nebulizer to vibrate the active mesh of the active mesh nebulizer;

providing the at least one plume of particles to a patient during inhalation; and

monitoring delivering the prescribed dose of the SRA by monitoring an amount of time that an active mesh of the active mesh nebulizer vibrates to produce the plume of particles.

2. The method of claim 1 , further comprising

evaluating patient headache symptoms subsequent to directing the plume of particles into the lungs of the patient; and

determining whether to provide an additional prescribed dose of the SRA.

3. The method of claim 2 , wherein evaluating patient headache symptoms comprises:

waiting, subsequent to directing the plume of particles into a lung of the patient during inhalation, from 5 to 10 minutes.

4. The method of claim 3 , further comprising:

determining, based on a result of evaluating patient headache symptoms, whether to generate another plume of particles of the solution having the SRA; and

generating a second plume of particles of the solution having the SRA; and

directing the second plume of particles into the lungs of the patient during inhalation.

5. The method of claim 1 , wherein the SRA is a solution of a 5-hydroxytryptamine (5-HT) agonist in water.

6. The method of claim 5 , wherein providing a solution having a SRA in the active mesh nebulizer further comprises providing a solution of a 5-HT 1B , a 5-HT 1D , or a 5-HT 1F agonist in water.

7. The method of claim 6 , wherein providing a solution having a 5-HT 1B , a 5-HT 1D , or a 5-HT 1F agonist further comprises providing a SRA in the triptan family in water.

8. The method of claim 7 , wherein providing a SRA in the triptan family further comprises providing a solution containing sumatriptan succinate in water.

9. The method of claim 5 , wherein providing the dose of SRA further comprises providing a solution of a 5-HT 1B , a 5-HT 1D , or a 5-HT 1F agonist in water.

10. The method of claim 1 , wherein the SRA solution comprises a 5-hydroxytryptamine (5-HT) agonist in water.

11. A method of relieving symptoms of migraine or cluster headache, comprising:

receiving, in a controller of the active mesh nebulizer, information regarding a prescribed dose of the SRA in an SRA solution;

determining a number of vibration periods of an active mesh of the active mesh nebulizer to deliver the prescribed dose of the SRA, wherein the number of vibration periods is based on a delivery rate of the SRA through the active mesh of the active mesh nebulizer, and wherein the number of vibration periods corresponds to vibrating the active mesh for a first vibration time;

generating at least one plume of particles of the SRA solution by vibrating the active mesh for each vibration period of the number of vibration periods;

providing the plume of particles of the SRA solution to a patient during at least one a first inhalation; and

monitoring delivering the dose of the SRA by monitoring an amount of time that the active mesh of the active mesh nebulizer vibrates to produce the plume of particles.

12. The method of claim 11 , further comprising:

evaluating patient headache symptoms following providing the patient the plume of particles during the first inhalation; and

determining whether to provide an additional dose of the SRA to the patient.

13. The method of claim 12 , wherein evaluating patient headache symptoms further comprises:

waiting, after providing the plume of particles of the SRA solution to a patient during the first inhalation, from 5 to 10 minutes before evaluating patient headache symptoms.

14. The method of claim 13 , further comprising:

determining, based on a result of evaluating patient headache symptoms, whether to generate another plume of particles of the SRA solution;

generating a second plume of particles of the SRA solution; and

providing the plume of particles of the SRA solution to a patient during a second inhalation.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 1, 2020
From: PELL, DONALD M; PELL, PAULA; SPUZA, MICHAEL; NAIR, GOVINDAN
To: BN INTELLECTUAL PROPERTIES, INC.
Reel/Frame 052549/0533 →
Continuity (3)
Continuation In Part 16836485 · Mar 31, 2020
Continuation In Part 16547072 · Aug 21, 2019
Related Publication 20210052552A1 · Feb 25, 2021
Cited By (1)
US 12,194,037