Pharmaceutical composition and device for treating pain

• US 10,406,299 B2
• Filed: 02/08/2016
• 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): Bosworth, Kami A
• Application Number:
  US15/120,120
• Publication Number:
  US 20170100333A1
• Time in Patent Office: 1,310 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

The invention relates to a system for the sequential intranasal administration of at least one active ingredient selected from a DR group having at least one side effect of respiratory depression and at least one active ingredient selected from an ADR group that counteracts the respiratory depression that may be induced by the active ingredients of the DR group. The invention also relates to a portable sequential intranasal administration device comprising an intranasal administration system according to the principles of the invention.

Claims

1. A method for sequential intranasal administration of at least one active ingredient selected from a DR group having at least one side effect of respiratory depression and at least one active ingredient selected from an ADR group that counteracts respiratory depression that may he induced by the at least one active ingredient of the DR group, the method comprising:

administering, from a first storage space, an initial dose of a first active formulation comprising the at least one active ingredient selected from the DR group, in response to an initial actuation of a portable sequential intranasal administration medical device by a patient wishing to receive pharmaceutical administration; and

after administering the initial dose, administering, from at least a second storage space, at least one subsequent dose of a second active formulation different from the first active formulation comprising the at least one active ingredient selected from the ADR group without administering the first active formulation, in response to at least one subsequent actuation of the portable sequential intranasal administration medical device by the patient wishing to receive subsequent pharmaceutical administration.

2. The method for sequential intranasal administration of claim 1, wherein the first active formulation further comprises at least one active ingredient from the ADR group.

3. The method for sequential intranasal administration of claim 2, wherein the at least one active ingredient from the ADR group of the first active formulation is identical to the at least one active ingredient from the ADR group of the second active formulation.

4. The method for sequential intranasal administration of claim 1, wherein the portable sequential intranasal administration medical device comprises at least one device for measuring at least one of time or at least one biological parameter, the method further comprising measuring at least one of time or at least one biological parameter via the at least one device, wherein administering the at least one subsequent dose is based on the measured time and/or the at least one biological parameter.

5. The method for sequential intranasal administration of claim 4, wherein the at least one device for measuring at least one of time or at least one biological parameter is configured to measure at least one of oxygen saturation or respiratory rate.

6. The method for sequential intranasal administration of claim 1, wherein the second active formulation further comprises at least one active ingredient from the DR group.

7. The method for sequential intranasal administration of claim 6, wherein the at least, one active ingredient from the DR group of the second active formulation is identical to the at least one active ingredient from the DR group of the first active formulation.

8. The method for sequential intranasal administration of claim 1, wherein the at least one active ingredient from the DR group is selected from a group consisting of benzodiazepines and the least one active ingredient from the ADR group is flumazenil.

9. The method for sequential intranasal administration of claim 1, wherein the at least one active ingredient from the DR group is sufentanil and the at least one active ingredient from the ADR group is naloxone.

10. The method for sequential intranasal administration of claim 1, wherein the at least one active ingredient from the DR group is selected from a group consisting of opioid agonists and the at least one active ingredient from the ADR group is selected from a group consisting of opioid antagonists.