Granted Patent B2

US 12,343,472 · App. 16/975,701 · Granted Jul 1, 2025

Inventor: Shunji Haruta (Kagoshima, JP)

Assignee: Shin Nippon Biomedical Laboratories, Ltd.

A61M15/08A61K9/0075A61K9/14A61K45/06A61M11/001A61M15/0065A61M15/0086A61M2202/064

Abstract

Claims (53)

1. A method comprising administering a powder preparation to an olfactory region in a nasal cavity,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.1 to 0.5 g/cm 3 , and a Hausner ratio of 1.6 to 2.4;

wherein the powder preparation is injected into the nasal cavity at a maximum air pressure of 15 to 80 kPa;

wherein the maximum air pressure is reached at 0 to 30 msec;

wherein the powder preparation is continuously injected at an air pressure of 10 kPa or more for a duration of 20 to 80 msec; and

wherein 20% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the olfactory region.

2. A method for treating a central nervous system disease, or for performing an examination or diagnosis or a pre-operational or pre-examination treatment based on action on a central nervous system, comprising administering a powder preparation to an olfactory region in a nasal cavity of a patient in need thereof,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.1 to 0.5 g/cm 3 , and a Hausner ratio of 1.6 to 2.4;

wherein the powder preparation is injected into the nasal cavity at a maximum air pressure of 15 to 80 kPa;

wherein the maximum air pressure is reached at 0 to 30 msec;

wherein the powder preparation is continuously injected at an air pressure of 10 kPa or more for a duration of 20 to 80 msec; and

wherein 20% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the olfactory region.

3. A method comprising administering a powder preparation to a respiratory region in a nasal cavity,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.2 to 1.1 g/cm 3 , and a Hausner ratio of 1.0 to 2.2;

wherein the powder preparation is injected into the nasal cavity at a maximum air pressure of 5 to 40 kPa;

wherein the maximum air pressure is reached at 53 to 150 msec;

wherein the powder preparation is continuously injected at an air pressure of 5 kPa or more for a duration of 40 to 200 msec;

wherein 50% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the respiratory region; and

wherein 0% to 5% by weight of the active ingredient delivered into the nasal cavity is distributed in an olfactory region.

4. A method for treating a systemic disease, or for performing an examination or diagnosis or a pre-operational or pre-examination treatment, comprising administering a powder preparation to a respiratory region in a nasal cavity of a patient in need thereof,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.2 to 1.1 g/cm 3 , and a Hausner ratio of 1.0 to 2.2;

wherein the powder preparation is injected into the nasal cavity at a maximum air pressure of 5 to 40 kPa;

wherein the maximum air pressure is reached at 53 to 150 msec;

wherein the powder preparation is continuously injected at an air pressure of 5 kPa or more for a duration of 40 to 200 msec;

wherein 50% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the respiratory region; and

wherein 0% to 5% by weight of the active ingredient delivered into the nasal cavity is distributed in an olfactory region.

5. A method for treating an infection, comprising administering a powder preparation to a respiratory region in a nasal cavity of a patient in need thereof,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.2 to 1.1 g/cm 3 , and a Hausner ratio of 1.0 to 2.2;

wherein the powder preparation is injected at a maximum air pressure of 5 to 40 kPa;

wherein the maximum air pressure is reached at 53 to 150 msec;

wherein the powder preparation is continuously injected at an air pressure of 5 kPa or more for a duration of 40 to 200 msec;

wherein the infection is at least one of bacterial infection, fungal infection or viral infection;

wherein 50% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the respiratory region; and

wherein 0% to 5% by weight of the active ingredient delivered into the nasal cavity is distributed in an olfactory region.

6. The method according to claim 1 , wherein the powder preparation has a specific surface area of 0.3 to 2.5 m 2 /g.

7. The method according to claim 2 , wherein the powder preparation has a specific surface area of 0.3 to 2.5 m 2 /g.

8. The method according to claim 1 , wherein the powder preparation has an average particle diameter of 10 to 150 μm.

9. The method according to claim 2 , wherein the powder preparation has an average particle diameter of 10 to 150 μm.

10. The method according to claim 3 , wherein the powder preparation has a specific surface area of 0.2 to 2.5 m 2 /g.

11. The method according to claim 4 , wherein the powder preparation has a specific surface area of 0.2 to 2.5 m 2 /g.

12. The method according to claim 5 , wherein the powder preparation has a specific surface area of 0.2 to 2.5 m 2 /g.

13. The method according to claim 3 , wherein the powder preparation has an average particle diameter of 10 to 500 μm.

14. The method according to claim 4 , wherein the powder preparation has an average particle diameter of 10 to 500 μm.

15. The method according to claim 5 , wherein the powder preparation has an average particle diameter of 10 to 500 μm.

16. A method for preventing an infection, comprising administering a powder preparation to a respiratory region in a nasal cavity of a patient in need thereof,

wherein the powder preparation comprises an active ingredient, the powder preparation having a bulk density of 0.2 to 1.1 g/cm 3 , and a Hausner ratio of 1.0 to 2.2;

wherein the powder preparation is injected at a maximum air pressure of 5 to 40 kPa;

wherein the maximum air pressure is reached at 53 to 150 msec;

wherein the powder preparation is continuously injected at an air pressure of 5 kPa or more for a duration of 40 to 200 msec;

wherein the infection is at least one of bacterial infection, fungal infection or viral infection;

wherein the active ingredient is a vaccine;

wherein 50% by weight or more of the active ingredient delivered into the nasal cavity is distributed in the respiratory region; and

wherein 0% to 5% by weight of the active ingredient delivered into the nasal cavity is distributed in an olfactory region.

Assignments (1)

Priority Claims (1)

Continuity (1)

References Cited (34)