Inhaler and methods of use thereof

• US 10,238,821 B2
• Filed: 10/10/2017
• Issued: 03/26/2019
• Est. Priority Date: 10/11/2016
• Status: Active Grant

• Current Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Akouka, Henri, Becker, Daniel, Hyer, Renee, Oakum, Craig
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US15/729,526
• Publication Number:
  US 20180104424A1
• Time in Patent Office: 532 Days
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/4418 having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 : Antiasthmatics
• CPC Class Codes: A61P 11/12 : Mucolytics

Abstract

A medicament delivery device comprises a dosing chamber configured to contain dry powder medicament, a transducer and a controller electrically coupled to the transducer. The medicament delivery device is capable of delivering a therapeutically effective dose of dry powder medicament in response to between 2-20 tidal inhalations, the dose preferably having a mass median aerodynamic diameter (MMAD) of about 6 microns or less and a fine particle fraction of at least 30%.

Claims

1. A medicament delivery device comprising:

a dosing chamber comprising an interior that is configured to contain dry powder medicament received from a medicament container,

a transducer confronting the dosing chamber, wherein the dosing chamber and the transducer are acoustically resonant such that the dosing chamber is configured to resonate in response to an activation of the transducer, and

a controller electrically coupled to the transducer and configured to send an electrical signal that activates the transducer when the medicament delivery device senses a subject'"'"'s dosing breath,

the medicament delivery device having a flow resistance in a range from about 0.040 cmH2O^0.5/LPM to about 0.1 cmH2O^0.5/LPM at 30 liters per minute (LPM) and capable of delivering a therapeutically effective dose of dry powder medicament in response to between 2-20 tidal inhalations, the dose having a mass median aerodynamic diameter (MMAD) of about 6 microns or less and a fine particle fraction of at least 30%.

2. The medicament delivery device of claim 1, wherein the controller is configured to activate the transducer for a total on-time of 5 seconds or less over the 2-20 tidal inhalations.

3. The medicament delivery device of claim 1, wherein the controller is configured to activate the transducer for between 50 ms and about 1000 ms during each dosing breath.

4. The medicament delivery device of claim 1, wherein the medicament delivery device is capable of delivering the dose of dry powder medicament at flow rates at least within a range of about 15 LPM to about 30 LPM.

5. The medicament delivery device of claim 1, wherein the medicament delivery device is capable of delivering the dose of dry powder medicament at flow rates at least within a range of about 15 LPM to about 90 LPM.

6. The medicament delivery device of claim 1, wherein the medicament delivery device is configured to administer at least 10% of the dry powder medicament dose in response to a first dosing breath.

7. The medicament delivery device of claim 1 comprising a base and a removable cartridge, and one or more doses of dry powder medicament are contained in the removable cartridge.

8. The medicament delivery device of claim 7, wherein the amount of each of the one or more doses of dry powder medicament is from about 1 mg to about 10 mg.

9. The medicament delivery device of claim 1 comprising one or more lights configured to illuminate when a dose has been administered.

10. A method of treating a respiratory disease or condition, or one or more symptoms thereof, the method comprising:

inhaling a therapeutically effective dose of dry powder medicament through a medicament delivery device using between 2-20 tidal inhalations over the course of an inhalation cycle, the inhalation cycle comprising dosing breaths,

wherein the medicament delivery device comprises a vibratory element that is activated upon each dosing breath and causes dry powder medicament to be aerosolized within a dosing chamber and expelled from one or more openings in the dosing chamber into an air flow conduit, the dosing chamber receiving the dry powder medicament from a medicament container, wherein pressure oscillations in the dosing chamber are sufficiently high at the one or more openings to aerosolize and expel the dry powder medicament via synthetic jetting,

the medicament delivery device having a flow resistance in a range from about 0.040 cmH2O^0.5/LPM to about 0.1 cmH2O^0.5/LPM at 30 liters per minute (LPM) and capable of delivering the dose of dry powder medicament at flow rates at least within a range of about 15 LPM to about 30 LPM,

wherein the dose of dry powder medicament administered by the medicament delivery device has a mass median aerodynamic diameter (MMAD) of about 6 microns or less and a fine particle fraction of at least 30%.

11. The method of claim 10 further comprising exhaling away from the medicament delivery device after each tidal inhalation.

12. The method of claim 10, wherein the medicament delivery device comprises a base and a removable cartridge, the method further comprising attaching the base and the removable cartridge together.

13. The method of claim 10, wherein the medicament delivery device administers at least 10% of the dry powder medicament dose in response to the first dosing breath in the inhalation cycle.

14. The method of claim 10, wherein the transducer has an on-time of about 5 seconds or less over the course of the inhalation cycle.

15. The method of claim 10, wherein the medicament delivery device achieves maximum synthetic jetting within about 1000 ms or less from the start of each transducer activation.

16. The method of claim 10, wherein the dose of dry powder medicament is administered within 2 minutes or less.

17. The method of claim 10, wherein the respiratory disease or condition is COPD.

18. The method of claim 10, wherein the respiratory disease or condition is COPD and the dry powder medicament comprises a LAMA and a LABA.

19. The method of claim 10, wherein the respiratory disease or condition is COPD and the dry powder medicament comprises glycopyrronium bromide and formoterol fumarate.

20. The method of claim 10, wherein the respiratory disease or condition is asthma.

21. The method of claim 10, wherein the respiratory disease or condition is cystic fibrosis and the dry powder medicament comprises one or more antibiotics.

22. The method of claim 10, wherein the respiratory disease or condition is cystic fibrosis and the dry powder medicament comprises DNase.

23. The method of claim 10, wherein the respiratory disease or condition is idiopathic pulmonary fibrosis and the dry powder medicament comprises pirfenidone.

24. A method of increasing FEV₁ in a subject, the method comprising:

inhaling a therapeutically effective dose of dry powder medicament through a medicament delivery device using between 2-20 tidal inhalations over the course of an inhalation cycle, the inhalation cycle comprising dosing breaths,

wherein the medicament delivery device comprises a vibratory element that is activated upon each dosing breath and causes dry powder medicament to be aerosolized within a dosing chamber and expelled from one or more openings in the dosing chamber into an air flow conduit, the dosing chamber receiving the dry powder medicament from a medicament container, wherein pressure oscillations in the dosing chamber are sufficiently high at the one or more openings to aerosolize and expel the dry powder medicament via synthetic jetting,

the medicament delivery device having a flow resistance in a range from about 0.040 cmH2O^0.5/LPM to about 0.1 cmH2O^0.5/LPM at 30 liters per minute (LPM) and capable of delivering the dose of dry powder medicament at flow rates at least within a range of about 15 LPM to about 30 LPM,

wherein the dose of dry powder medicament delivered by the medicament delivery device has a mass median aerodynamic diameter (MMAD) of about 6 microns or less and a fine particle fraction of at least 30%.

25. The method of claim 24, wherein the medicament delivery device administers at least 10% of the dry powder medicament dose in response to the first dosing breath in the inhalation cycle.

26. The method of claim 24, wherein the transducer has an on-time of about 5 seconds or less over the course of the inhalation cycle.

27. The method of claim 24, wherein the medicament delivery device achieves maximum synthetic jetting within about 1000 ms or less from the start of each transducer activation.

28. The method of claim 24, wherein the dry powder medicament comprises formoterol fumarate.

29. The method of claim 24, wherein the medicament delivery device is capable of delivering the dose of dry powder medicament at flow rates at least within a range of about 15 LPM to about 20 LPM.

30. A medicament delivery device comprising:

a dosing chamber comprising an interior that is configured to contain dry powder medicament,

a transducer confronting the dosing chamber, wherein the dosing chamber and the transducer are acoustically resonant such that the dosing chamber is configured to resonate in response to an activation of the transducer,

a controller electrically coupled to the transducer and configured to send an electrical signal that activates the transducer when the medicament delivery device senses a subject'"'"'s dosing breath, and

an air flow conduit extending from an air inlet to an outlet, the air flow conduit comprising (i) an upstream area disposed upstream from an area of the air flow conduit into which the dry powder medicament is expelled from the dosing chamber, and (ii) a downstream area disposed downstream from the area of the air flow conduit into which the dry powder medicament is expelled from the dosing chamber, the downstream area comprising the outlet and an exit channel disposed about an exit channel axis, wherein the upstream area comprises the air inlet and a first leg of an upper flow path in fluid communication with the exit channel, the first leg disposed about a first leg axis transverse to both the exit channel axis and a dosing chamber axis,

wherein the dosing chamber'"'"'s interior shape is at least partially defined by a lower sidewall that transitions to a shoulder, the shoulder transitions to an apex extending away from the lower sidewall, and the apex converges to a point,

wherein one or more openings in the dosing chamber are disposed in the apex, and

wherein an internal height of the dosing chamber is configured so that pressure oscillation at the one or more openings is sufficiently high to cause the dry powder medicament to become aerosolized and delivered from the one or more openings,

the medicament delivery device having a flow resistance in a range from about 0.040 cmH2O^0.5/LPM to about 0.1 cmH2O^0.5/LPM at 30 liters per minute (LPM) and capable of delivering a therapeutically effective dose of dry powder medicament in response to between 2-20 tidal inhalations, the dose having a mass median aerodynamic diameter (MMAD) of about 6 microns or less and a fine particle fraction of at least 30%.