# US 2016/0354558 A1 · Dual chamber inhaler for sequentially administering multiple drugs

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- Number: US 2016/0354558 A1
- Document ID: US20160354558A1
- Status: Published application
- Kind: A1
- Application number: 15/241,030
- Filed: 2016-08-18
- Published: 2016-12-08
- Earliest claimed: 2015-02-06
- Assignees: Vapomed Limited
- Inventors: Jacques SEGUIN; Emad SABRY
- Web page: https://patentgrep.com/patent/US20160354558A1

## CPC

- A61M 11/00: Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14})
- A61K 9/0043: {Nose}
- 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}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/5517: condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 15/08: Inhaling devices inserted into the nose
- 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})
- 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)}
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/36: Opioid-abuse
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/583: by visual feedback
- A61M 2205/587: Lighting arrangements
- A61M 2205/8206: battery-operated
- A61M 2205/8256: being integrated in the case or housing of the apparatus
- A61M 2205/8262: connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter
- A61M 2210/0618: Nose
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/20: Blood composition characteristics
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/42: Rate
- A61M 2230/435: partial O2 pressure (P-O2)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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

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

### Claim 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 permit communication between the first chamber or the second chamber, and the dispensing nozzle.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 5)

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.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 10)

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.

### Claim 12 (depends on 11)

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.

### Claim 13 (depends on 10)

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.

### Claim 14 (depends on 10)

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

### Claim 15 (depends on 14)

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.

### Claim 16 (depends on 10)

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.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 16)

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.

### Claim 19 (depends on 10)

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

### Claim 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.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 20)

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 or the second sprayable active formulation upon activation of the actuator by the patient based on the one or more signals.
