Inhaled preparation of isoglycyrrhizic acid or salt thereof, and use in preparing drugs for treating respiratory system diseases

Patent metadata

Field	Value
Publication number	US-11534398-B2
Application number	US-202016988289-A
Country	US
Kind code	B2
Filing date	Aug 7, 2020
Priority date	Apr 15, 2016
Publication date	Dec 27, 2022
Grant date	Dec 27, 2022

Abstract

The present invention belongs to the field of medicine, relates to an inhaled preparation of isoglycyrrhizic acid or a salt thereof, and in particular relates to an inhaled preparation of magnesium isoglycyrrhizinate and the use thereof in preparing drugs for treating respiratory system diseases.

First claim

What is claimed is:

1. A method for alleviating phlegm by administrating an inhaled preparation of magnesium isoglycyrrhizinate to a subject in need thereof, characterized in that the inhaled preparation delivers the magnesium isoglycyrrhizinate to lungs to exert a local or systemic effect,
wherein the inhaled preparation is a liquid preparation for use in a nebulizer or powder fir inhalation,
wherein the liquid preparation for use in a nebulizer comprising magnesium isoglycyrrhizinate, sodium chloride, ammonium hydroxide, and water for injection, with the pH of 6.5-7.0, the nebulizer being a continuous nebulizer or a quantitative nebulizer, the amount of the magnesium isoglycyrrhizinate being from 0.1 mg/ml to 5 mg/ml, and the amount of the sodium chloride being 9 mg/ml;
wherein the powder for inhalation comprises magnesium isoglycyrrhizinate and one or more pharmaceutically acceptable carriers, the magnesium isoglycyrrhizinate being micronized and has a particle size of 0.5-10 μm, and the pharmaceutically acceptable carrier being ground lactose, sieved lactose or a mixture of sieved lactose and fine lactose, the particle size distribution of the ground lactose ranging from 1 to 350 μm, the particle size distribution of the sieved lactose ranging from 1 to 200 μm and the article size distribution of the time lactose ranges being from 1 to 60 μm, the ground lactose having a particle size distribution of X 50 being 30-110 μm, the sieve lactose having a particle size distribution of X 50 being 35-115 μm, and the fine lactose having a particle size distribution of X 90 <45 μm.

2. The method according to claim 1 , characterized in that the amount of the magnesium isoglycyrrhizinate is from 0.1 mg/ml to 2.5 mg/ml.

3. The method according to claim 1 , characterized in that the inhaled preparation is packaged in a single dose in a package size of 1 ml, 2 ml or 5 ml.

4. The method according to claim 1 , characterized in that the magnesium isoglycyrrhizinate has a particle size of 0.5-5 μm.

5. The method according to claim 1 , characterized in that the micronized magnesium isoglycyrrhizinate and the carrier are mixed and filled into a capsule or a blister.

6. The method according to claim 5 , characterized in that each capsule or blister comprises 1-50 mg of micronized magnesium isoglycyrrhizinate and 0-50 mg of lactose.

7. The method according to claim 5 , characterized in that each capsule or blister comprises 1-30 mg of micronized magnesium isoglycyrrhizinate and 1-40 mg of lactose.

8. The method according to claim 1 , characterized in that the powder for inhalation further comprises: one or more pharmaceutically acceptable additives selected from the group consisting of surfactants, lubricants and flavoring agents.

9. The method according to claim 8 , characterized in that the pharmaceutically acceptable additive is magnesium stearate and/or phospholipid.

10. The method according to claim 1 , characterized in that the administration frequency of the inhaled preparation to a subject is selected from: up to three limes a day, up to twice a day, up to once a day and up to once every other day.

Assignees

• Chia Tai Tianqing Pharmaceutical Group Co Ltd

Inventors

• Gu Hongmei
• Wang Shanchun
• Zhang Xiquan
• Huang Lei
• Xu Hongjiang
• Song Wei
• Dong Ping
• Sun Zhongying
• Zhang Ying
• Chen Deyang

Classifications

• B82Y5/00

  Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery · CPC title

• A61K9/12 Primary

  Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)} · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K9/0075 Primary

  for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles · CPC title

• A61K47/02

  Inorganic compounds · CPC title