Dual chamber inhaler for sequentially administering multiple drugs

• US 10,406,300 B2
• Filed: 08/18/2016
• Issued: 09/10/2019
• Est. Priority Date: 02/06/2015
• Status: Active Grant

• Current Assignee: Emad Sabry, Jacques Seguin
• Original Assignee: Vapomed Limited
• Inventors: Seguin, Jacques, Sabry, Emad
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US15/241,030
• Publication Number:
  US 20160354558A1
• Time in Patent Office: 1,118 Days
• 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 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/5517 condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8256 being integrated in the case or housing of the apparatus
• CPC Class Codes: A61M 2205/8262 : connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter
• CPC Class Codes: A61M 2210/0618 : Nose
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 39/22 : Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/36 : Opioid-abuse
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Devices and methods for sequential aerosolized administration of pharmaceutical agents. A portable device may be used to administer an initial dose of an active formulation comprising at least one first pharmaceutical agent and a subsequent dose of an active formulation comprising at least one second pharmaceutical agent that may have the effect of countering, enhancing, or mitigating the first pharmaceutical agent.

Claims

1. A portable medical device for sequential aerosolized administration of at least two pharmaceutical agents, the device comprising:

a first chamber configured to have a first sprayable active formulation disposed therein, the first sprayable active formulation comprising a first pharmaceutical agent;

a second chamber configured to have a second sprayable active formulation disposed therein, the second sprayable active formulation comprising a second pharmaceutical agent having an effect of countering, enhancing, or mitigating an effect of the first pharmaceutical agent;

a dispensing nozzle configured to permit an initial administration of the first sprayable active formulation, the dispensing nozzle further configured to permit one or more subsequent administrations of the second sprayable active formulation through a bodily tissue; and

a valve chamber in communication with the first chamber, the second chamber, and the dispensing, nozzle, the valve chamber having a valve member configured to move between a first position where the valve member only permits communication between the first chamber and the dispensing nozzle, and a second position where the valve member only permits communication between the second chamber and the dispensing nozzle.

2. The device of claim 1, wherein the first sprayable active formulation comprises a first pharmaceutical agent having at least one active ingredient selected from a drug group, and wherein the second sprayable active formulation comprises a second pharmaceutical agent having at least one active ingredient selected from an antidote group.

3. The device of claim 2, wherein the first sprayable active formulation comprises a first pharmaceutical agent having at least one active ingredient selected from a drug group comprising opioid agonists, and wherein the second sprayable active formulation comprises a second pharmaceutical agent having at least one active ingredient selected from an antidote group comprising opioid antagonists.

4. The device of claim 2, wherein the first sprayable active formulation comprises a first pharmaceutical agent having at least one active ingredient selected from a drug group comprising benzodiazepines, and wherein the second sprayable active formulation comprises a second pharmaceutical agent having at least one active ingredient selected from an antidote group comprising benzodiazepine antagonists.

5. The device of claim 1, wherein the first sprayable active formulation further comprises a second pharmaceutical agent having an effect of countering, enhancing, or mitigating an effect of the first pharmaceutical agent.

6. The device of claim 5, wherein the second pharmaceutical agent of the first sprayable active formulation is identical to the second pharmaceutical agent of the second sprayable active formulation.

7. The device of claim 1, wherein the second sprayable active formulation further comprises a first pharmaceutical agent.

8. The device of claim 7, wherein the first pharmaceutical agent of the second sprayable active formulation is identical to the first pharmaceutical agent of the first sprayable active formulation.

9. The device of claim 1, wherein the dispensing nozzle is configured to permit the initial and one or more subsequent, administrations of the first and second active formulations through the bodily tissue comprising at least one of a nasal mucosa, a buccal mucosa, a rectal mucosa, a bladder mucosa, a vaginal mucosa, a lung tissue, or a pulmonary tissue.

10. The device of claim 1, further comprising:

a signal processing unit operatively connected to the valve chamber;

one or more sensors operatively connected to the signal processing unit, the one or more sensors configured to measure data;

one or more sensory alarms operatively connected to the signal processing unit, the one or more sensory alarms configured to communicate to a patient one or more signals indicative of whether the valve member is positioned to permit communication between the first chamber or second chamber, and the dispensing nozzle, based on the measured data;

an actuator operatively connected to the signal processing unit, the actuator configured to be activated by the patient, based on the one or more signals, to cause the signal processing unit to permit administration of the first sprayable active formulation or the second sprayable active formulation; and

a power source configured to provide energy to the device.

11. The device of claim 10, wherein the signal processing unit further comprises a memory configured to store at least one of the measured data or predetermined threshold values.

12. The device of claim 11, wherein the signal processing unit is further configured to perform one or more comparisons between the measured data and the predetermined threshold values, and wherein the one or more sensory alarms are configured to communicate one or more signals indicative of whether the valve member is positioned to permit the administration of the first sprayable active formulation or the second sprayable active formulation, based on the one or more comparisons.

13. The device of claim 10, wherein at least one of the one or more sensors comprises a timer configured to measure a time interval elapsed from the time of the data measurement and a previous administration.

14. The device of claim 10, wherein at least one of the one or mor sensors comprises a flow sensor configured to measure an amount of active formulation administered.

15. The device of claim 14, wherein the signal processing unit is further configured to permit one or more subsequent administrations of a controlled dosage of the second sprayable active formulation having an amount of the second pharmaceutical agent sufficient to counter undesirable side effects induced by a previous administration of the first sprayable active formulation based, on the amount measured by the flow sensor.

16. The device of claim 10, wherein at least one of the one or more sensors comprises a device configured to measure at least one biological parameter.

17. The device of claim 16, wherein the device configured to measure at least one biological parameter comprises at least one of an oximeter or a respiratory rate sensor.

18. The device of claim 16, wherein the device configured to measure at least one biological parameter is configured to be positioned on the dispensing nozzle.

19. The device of claim 10, wherein at least one of the one or more sensory alarms comprises a device configured to emit light.

20. A method for sequential aerosolized administration of at least two pharmaceutical agents for the treatment of pain, the method comprising:

selecting a portable device for sequential aerosolized administration of at least two pharmaceutical agents for the treatment of pain, the device comprising a first chamber having a first sprayable formulation disposed therein, a second chamber having a second sprayable formulation disposed therein, a dispensing nozzle configured to permit administration of the first sprayable formulation and the second sprayable formulation, and a valve chamber in communication with the first chamber, the second chamber, and the dispensing nozzle, the valve chamber having a valve member configured to permit communication between the first chamber or the second chamber, and the dispensing nozzle;

administering an initial dose of the first sprayable active formulation alone through a bodily tissue of a patient, the first sprayable active formulation comprising a first pharmaceutical agent; and

administering a subsequent dose of the second sprayable active formulation alone through the bodily tissue of the patient, the second sprayable active formulation comprising a second pharmaceutical agent having an effect of countering, enhancing, or mitigating an effect of the first pharmaceutical agent;

wherein the first and second sprayable active formulations are not co-administered simultaneously.

21. The method of claim 20, further comprising administering a subsequent dose of the first sprayable active formulation alone through the bodily tissue of the patient prior to the administration of the subsequent dose of the second sprayable active formulation.

22. The method of claim 20, wherein the portable device for sequential aerosolized administration of at least two active formulations further comprises a signal processing, unit having a memory, the signal processing unit operatively connected to the valve chamber, one or more sensors, an actuator, and one or more sensory alarms, the signal processing unit configured to:

receive measured data indicative of at least one of a time interval since a previous administration, an amount of active formulation administered, or a biological parameter from the one or more sensors;

compare the measured data to a predetermined threshold value stored in the memory;

actuate the valve chamber to position the valve member to permit communication between the first chamber or the second chamber, and the dispensing nozzle based on the comparison;

direct the one or more sensory alarms to communicate one or more signals to the patient based on the comparison; and

permit administration of the first sprayable active formulation the sewn sprayable active formulation upon activation of the actuator by the patient based on the one or more signals.