NASAL ADMINISTRATION
An apparatus or method for delivering a substance, such as one or more of a triptan, a topical steroid or carbon dioxide gas, to the nasal cavity of a subject, in particular for the treatment of headaches, for example, migraine, or rhinosinusrtis, for example, chronic rhinosinusitis, optionally with polyps, the method comprising the steps of fitting a nosepiece to one nostril of the subject, delivering the substance through the nosepiece to the posterior region of the nasal cavity of the subject.
1 . An apparatus or method for therapeutically treating a patient, comprising:
administering, in a first step, a therapeutic agent; and
delivering, in a second step, to a location at an interior of a nasal passage of the patient a therapeutic amount of at least one of carbon dioxide or a pH adjusting material, wherein the first step is performed before, after, before and after and/or at the same time as the second step.
2 . The apparatus or method of claim 1 , wherein the first step is performed before the second step.
3 . The apparatus or method of claim 1 , wherein the first step is performed after the second step.
4 . The apparatus or method of claim 1 , wherein the second step is performed both before and after the first step and/or the first step is performed at the same time as the second step.
5 . The apparatus or method of claim 1 , wherein the location includes an upper posterior region of the nasal passage.
6 . The apparatus or method of claim 1 , wherein the therapeutic agent includes sumatriptan, optionally in the form of sumatriptan succinate, optionally administered as a powder aerosol.
7 . The apparatus or method of claim 1 , wherein the therapeutic agent includes a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.
8 . The apparatus or method of claim 7 , wherein the therapeutic agent is delivered in amount of at least 100 ug, optionally twice daily.
9 . The apparatus or method of claim 8 , wherein the therapeutic agent is delivered in amount of at least 200 ug, optionally twice daily.
10 . The apparatus or method of claim 9 , wherein the therapeutic agent Is delivered in amount of at least 400 ug, optionally twice daily.
11 . The apparatus or method of claim 8 , wherein the delivering comprises:
placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient, the mouthpiece being fluidly connected to the nosepiece; and
the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece;
and wherein the therapeutic agent when intranasally administered has a systemic bioavailability or pharmacokinetic (PK) profile which is equivalent to or not greater than the systemic bioavailability of 50 ug of the therapeutic agent when intranasally administered without the delivering.
12 . The apparatus or method of claim 1 , wherein the second step adjusts a pH in the nasal passage location by an amount ranging from about 0.01 to about 0.5 pH units.
13 . The apparatus or method of claim 12 , wherein the amount ranges from about 0.1 to about 0.2 pH units.
14 . The apparatus or method of claim 1 , wherein the second step comprises delivering a concentration of carbon dioxide from about 1% vol/vol to about 10% vol/vol carbon dioxide.
15 . The apparatus or method of claim 14 , wherein the concentration of carbon dioxide is from about 5% to about 6% vol/vol carbon dioxide.
16 . The apparatus or method of claim 1 , wherein delivering comprises:
placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient;
the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece; and
directing the fluid flow to the location within the nasal passage.
17 . The method of claim 16 , wherein delivering further comprises:
adjusting a pH at the location by controlling the fluid flow.
18 . The apparatus or method of claim 17 , wherein controlling the fluid flow includes at least one of controlling a duration, a rate, a pressure, and a composition of the fluid flow.
19 . The apparatus or method of claim 18 , comprising controlling the fluid flow duration to be in a range of from about 2 to about 3 seconds.
20 . The apparatus or method of claim 19 , comprising controlling the fluid flow rate at least 10 L/min, optionally at least 20 L/min, and optionally at about 30 L/min.
21 . The apparatus or method of claim 16 , wherein the delivering further comprises:
placing the nosepiece into a second nostril of the patient;
the patient exhaling a breath into the mouthpiece to create a second fluid flow out of the nosepiece; and
directing the second fluid flow to a second location within a second nasal passage.
22 . An apparatus or method for increasing a therapeutic effect of a pharmaceutical agent delivered to a patient, comprising:
delivering a fluid flow to a nasal passage of the patient to deliver about 5% to about 6% vol/vol carbon dioxide to a posterior region of the nasal passage; and
administering a dose of the pharmaceutical agent to the patient.
23 . The apparatus or method of claim 22 , further including lowering a pH of the posterior region of the nasal passage.
24 . The apparatus or method of claim 22 , wherein the pharmaceutical agent includes sumatriptan, optionally in the form of sumatriptan succinate, optionally administered as a powder aerosol.
25 . The apparatus or method of claim 22 , wherein the pharmaceutical agent includes a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.
26 . The apparatus or method of claim 25 , wherein the pharmaceutical agent is delivered in amount of at least 100 ug, optionally twice daily.
27 . The apparatus or method of claim 26 , wherein the pharmaceutical agent is delivered in amount of at least 200 ug, optionally twice daily.
28 . The apparatus or method of claim 27 , wherein the pharmaceutical agent is delivered in amount of at least 400 ug, optionally twice daily.
29 . The apparatus or method of claim 26 , wherein the delivering comprises:
placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient, the mouthpiece being fluidly connected to the nosepiece; and
the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece;
and wherein the pharmaceutical agent when intranasally administered has a systemic bioavailability or pharmacokinetic (PK) profile which is equivalent to or not greater than the systemic bioavailability or pharmacokinetic (PK) profile of 50 ug of the pharmaceutical agent when intranasally administered without the delivering.
30 . An apparatus or method for treating a patient, comprising delivering a concentration of about 5% to about 6% vol/vol carbon dioxide to a nostril of the patient to lower a pH of an upper posterior region of the nasal passage by at least about 0.1 pH units to provide a therapeutic or pharmacokinetic effect.
31 . The apparatus or method of claim 30 , further including administering a therapeutic agent to the patient at least one of orally, intranasally, intravenously, and sub-cutaneously.
32 . The apparatus or method of claim 30 , further including administering a dose of sumatriptan powder intranasally.
33 . The apparatus or method of claim 32 , the low dose includes less than 20 mg of a sumatriptan powder, optionally about 16 mg of sumatriptan powder, optionally in the form of sumatriptan succinate.
34 . The apparatus or method of claim 30 , further including administering a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.
35 . The apparatus or method of claim 34 , wherein the steroid is delivered in amount of at least 100 ug, optionally twice daily.
36 . The apparatus or method of claim 35 , wherein the steroid is delivered in amount of at least 200 ug, optionally twice daily.
37 . The apparatus or method of claim 36 , wherein the steroid is delivered in amount of at least 400 ug, optionally twice daily.
38 . The apparatus or method of claim 30 , wherein the delivering comprises:
placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient, the mouthpiece being fluidly connected to the nosepiece; and
the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece;
and wherein the steroid when intranasally administered has a systemic bioavailability or pharmacokinetic (PK) profile which is equivalent to or not greater than the systemic bioavailability or pharmacokinetic (PK) profile of 50 ug of the steroid when intranasally administered without the delivering.
39 . The apparatus or method of claim 30 , wherein the therapeutic or pharmacokinetic effect treats at least one of migraine and allergic rhinitis.
40 . The apparatus or method of claim 30 , further including substantially closing a soft palate of the patient during the delivery step.