NASAL ADMINISTRATION

• US 20170274164A1
• Filed: 04/07/2017
• Published: 09/28/2017
• Est. Priority Date: 04/05/2007
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: DJUPESLAND, Per Gisle, HAFNER, Roderick Peter
• Granted Patent: US 10,722,667 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61M 15/0005 with means for agitating the medicament
• CPC Class Codes: A61M 15/0008 rotating by airflow
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/003 using capsules, e.g. to be perforated or broken-up
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A delivery device for and method of delivering a powdered substance, in particular a triptan, such as sumatriptan, to the posterior region of a nasal cavity of a subject, in particular for the treatment of headaches, for example, cluster headaches and migraine, and neuropathic pain, the delivery device comprising: a nosepiece for insertion into a nasal cavity of a subject through which the powdered substance is delivered to the posterior region of the nasal cavity of the subject, in particular the upper posterior two thirds of the nasal cavity; and a substance supply unit which is operable to deliver the powdered substance through the nosepiece.

Claims

1-92. -92. (canceled)

93. A device for delivering powdered sumatriptan substance to a nasal cavity of a subject, comprising:

a nosepiece configured to be fit to a nostril of the subject, wherein the nosepiece is configured to extend into the nostril of the subject and expand at least a portion of a nasal valve of the subject; and

a substance containing unit connected to the nosepiece, the substance containing unit containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject, the powdered sumatriptan substance comprising a particle size distribution in which at least 10% of the particles are less than about 20 μ

m, at least 50% of the particles are less than about 50 μ

m, and at least 90% of the particles are less than about 150 μ

m;

wherein the device is configured such that, when the nosepiece is fitted to the nostril of the subject, oral exhalation by the subject through the substance containing unit and the nosepiece acts to close the oropharyngeal velum of the subject and produce an exhalation flow passing into one nasal passage of the subject and out of the other nasal passage of the subject, thereby achieving a bi-directional exhalation flow for delivering the powdered sumatriptan substance to a portion of the nasal cavity of the subject.

94. The device of claim 93, wherein the powdered sumatriptan substance comprises a sumatriptan base or sumatriptan succinate.

95. The device of claim 93, wherein the powdered sumatriptan substance contains only sumatriptan succinate and no introduced excipients or adjuvants.

96. The device of claim 93, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a substance container.

97. The device of claim 96, wherein the substance container is a capsule.

98. The device of claim 96, wherein the substance container contains a 10 mg dose of the powdered sumatriptan substance.

99. The device of claim 93, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a capsule.

100. The device of claim 93, wherein the powdered sumatriptan substance has a particle size distribution in which at least 10% of the particles are less than about 10 μ

m, at least 50% of the particles are less than about 30 μ

m, and at least 90% of the particles are less than about 90 μ

m.

101. The device of claim 93, further including a trap disposed between the substance containing unit and the nosepiece.

102. A device for delivering powdered sumatriptan substance to a nasal cavity of a subject, comprising:

a mouthpiece configured to be fit to an oral cavity of the subject;

a nosepiece configured to be fit to a nostril of the subject, wherein the nosepiece is configured to extend into the nostril of the subject and expand at least a portion of a nasal valve of the subject; and

a substance containing unit connected to the nosepiece, the substance containing unit containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject, the powdered sumatriptan substance comprising a particle size distribution in which at least 10% of the particles are less than about 20 μ

m, at least 50% of the particles are less than about 50 μ

m, and at least 90% of the particles are less than about 150 μ

m;

wherein the device is configured such that, when the nosepiece is fitted to the nostril of the subject and the mouthpiece is fitted to the oral cavity of the subject, oral exhalation by the subject through the mouthpiece, through the substance containing unit, and through the nosepiece acts to close the oropharyngeal velum of the subject and produce an exhalation flow passing into one nasal passage of the subject and out of the other nasal passage of the subject, thereby achieving a bi-directional exhalation flow for delivering the powdered sumatriptan substance to a portion of the nasal cavity of the subject.

103. The device of claim 102, wherein the powdered sumatriptan substance comprises a sumatriptan base or sumatriptan succinate.

104. The device of claim 102, wherein the powdered sumatriptan substance contains only sumatriptan succinate and no introduced excipients or adjuvants.

105. The device of claim 102, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a substance container.

106. The device of claim 105, wherein the substance container is a capsule.

107. The device of claim 105, wherein the substance container contains a 10 mg dose of the powdered sumatriptan substance.

108. The device of claim 102, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a capsule.

109. The device of claim 102, wherein the powdered sumatriptan substance has a particle size distribution in which at least 10% of the particles are less than about 10 μ

m, at least 50% of the particles are less than about 30 μ

m, and at least 90% of the particles are less than about 90 μ

m.

110. The device of claim 102, further including a trap disposed between the substance containing unit and the nosepiece.

111. The device of claim 102, further including a labyrinthine structure disposed between the mouthpiece and the substance containing unit.