NASAL ADMINISTRATION

• US 20140246022A1
• Filed: 05/09/2014
• Published: 09/04/2014
• 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 8,875,704 B2
• Time in Patent Office: Days
• US Class Current: 128/203.15
• 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 nasal delivery device for delivering powdered sumatriptan substance to a nasal cavity of a human subject, the delivery device comprising:

a nosepiece for fitting to a nasal cavity of the subject, and

a capsule-containing member which contains a capsule, the capsule containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject,

wherein the delivery device is configured to receive a housing and a mouthpiece unit through which the subject in use exhales, and the capsule-containing member includes a flow passage in which the capsule is disposed to be rotatable therewithin when an air flow is delivered therethrough, the flow passage including an inlet and an outlet which is in fluid communication with the nosepiece.

94. The delivery device of claim 93, wherein the inlet of the flow passage includes an inlet aperture which provides a flow restriction to an air flow as delivered therethrough.

95. The delivery device of claim 94, wherein the inlet aperture provides a seat for a lower end of the capsule prior to delivery of an air flow through the flow passage.

96. The delivery device of claim 93, wherein the flow passage is an elongate flow passage and the capsule is oriented axially therealong.

97. The delivery device of claim 93, wherein the delivery device is a replaceable nosepiece unit.

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

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

100. The delivery device of claim 99, wherein the capsule contains 10 mg of sumatriptan succinate powder.

101. The delivery device of claim 93, wherein the powdered sumatriptan substance has a pH of between 4.5 and 5.3.

102. The delivery device of claim 93, wherein the powdered sumatriptan substance has a particle size distribution of 10% less than about 20 μ

m, 50% less than about 50 μ

m and 90% less than about 150 μ

m.

103. The delivery device of claim 93, wherein the powdered sumatriptan substance has a particle size distribution of 10% less than about 10 μ

m, 50% less than about 30 μ

m and 90% less than about 90 μ

m.

104. The delivery device of claim 93, wherein the powdered sumatriptan substance has an untapped bulk density of between 0.3 g/ml and 0.5 g/ml.

105. The delivery device of claim 93, wherein the powdered sumatriptan substance has a tapped bulk density of between about 0.5 g/ml and about 0.75 g/ml.

116. A method of treating headache in a human subject, comprising the steps of:

providing a first delivery device of claim 93;

fitting a housing and a mouthpiece unit to the delivery device;

piercing the capsule in the first delivery device;

fitting the nosepiece of the first delivery device into a first nostril; and

the subject exhaling through the mouthpiece of the first delivery device to cause closure of the orpharyngeal velum of the subject and cause the capsule of the first delivery device to be rotated and release the powdered sumatriptan substance from within the capsule of the first delivery device and be entrained in an exhaled air flow.

117. The method of claim 116, further comprising the steps of:

removing the housing and the mouthpiece unit from the first delivery device;

providing a second delivery device of claim 93;

fitting the housing and the mouthpiece unit to the second delivery device;

piercing the capsule in the second delivery device;

fitting the nosepiece of the second delivery device into a second nostril of the subject; and

the subject exhaling through the mouthpiece of the second delivery device to cause closure of the orpharyngeal velum of the subject and cause the capsule of the second delivery device to be rotated and release the powdered sumatriptan substance from within the capsule of the second delivery device and be entrained in an exhaled air flow.

118. The method of claim 117, in the treatment of cluster headaches.

119. The method of claim 117, in the treatment of migraine.

120. The method of claim 117, wherein at least 55% of the dose as initially deposited in the nasal cavity is deposited in the region posterior of the nasal valve.

121. The method of claim 117, wherein at least 35% of the dose as initially deposited in the nasal cavity is deposited in the upper posterior two thirds thereof.

122. The method of claim 117, wherein the step of piercing a capsule comprises piercing the capsule at first and second spaced locations along an axial length thereof, and the first and second spaced locations are above a height of the powdered sumatriptan substance as contained by the capsule.

106. A delivery device for delivering powdered sumatriptan substance to a nasal cavity of a human subject, the delivery device comprising:

a nosepiece for fitting to a nasal cavity of the subject, and

a capsule-containing member which contains a capsule, the capsule containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject, the powdered sumatriptan substance containing only sumatriptan succinate and no introduced excipients or adjuvants,

wherein the delivery device is configured to receive a housing and a mouthpiece unit through which the subject in use exhales, and the capsule-containing member includes a flow passage in which the capsule is disposed to be rotatable therewithin when an air flow is delivered therethrough, the flow passage including an inlet and an outlet which is in fluid communication with the nosepiece.

107. The delivery device of claim 106, wherein the capsule contains 10 mg of sumatriptan succinate powder.

108. The delivery device of claim 106, wherein the powdered sumatriptan substance has a pH of between 4.5 and 5.3.

109. The delivery device of claim 106, wherein the powdered sumatriptan substance has an untapped bulk density of between 0.3 g/ml and 0.5 g/ml and a tapped bulk density of between about 0.5 g/ml and about 0.75 g/ml.

110. A nasal delivery device for delivering powdered sumatriptan to a nasal cavity of a human subject, the delivery device comprising:

a nosepiece for fitting to a nasal cavity of the subject, and

a capsule-containing member which contains a capsule, the capsule containing powdered sumatriptan to be delivered to the nasal cavity of the subject,

wherein the delivery device is configured to receive a housing and a mouthpiece unit through which the subject in use exhales, and the capsule-containing member includes a flow passage in which the capsule is disposed to be rotatable therewithin when an air flow is delivered therethrough, the flow passage including an inlet and an outlet which is in fluid communication with the nosepiece.

111. The delivery device of claim 110, wherein the powdered sumatriptan comprises a sumatriptan base or sumatriptan succinate.

112. The delivery device of claim 110, wherein the powdered sumatriptan contains only sumatriptan succinate and no introduced excipients or adjuvants.

113. The delivery device of claim 110, wherein the capsule contains 10 mg of sumatriptan succinate powder.

114. The delivery device of claim 110, wherein the powdered sumatriptan has a pH of between 4.5 and 5.3.

115. The delivery device of claim 110, wherein the powdered sumatriptan has an untapped bulk density of between 0.3 g/ml and 0.5 g/ml and a tapped bulk density of between about 0.5 g/ml and about 0.75 g/ml.