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1. WO2020157752 - COMPOSITION D'AÉROSOL PHARMACEUTIQUE

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CLAIMS

1. An aqueous solution of alpha 1 -antitrypsin (AAT) wherein when a therapeutic dose is administered by a nebulizer to generate an inhaled aerosol composition; said aerosol composition comprises AAT which retained at least about 96% specific activity after nebulization.

2. The aqueous solution of AAT as described in claim 1, wherein said aerosol composition comprises AAT which retained at least about 98% specific activity after nebulization.

3. The aqueous solution of AAT as described in claim 1, wherein said aerosol composition comprises not more than 500 sub-visible proteinaceous particles from about 5 micron to about 100 microns.

4. The aqueous solution of AAT as described in claim 3, wherein said aerosol composition comprises not more than 100 sub-visible proteinaceous particles from about 5 micron to about 100 microns.

5. The aqueous solution of AAT as described in claim 1, wherein the nebulizer is based on an pieso-electric based vibrating membrane technology.

6. The aqueous solution of AAT as described in claim 1, wherein the nebulizer is an eFlow nebulizer.

7. The aqueous solution of AAT as described in claim 1, wherein said aerosol composition comprises less than a 50% increase in the percentage of high molecular weight species after nebulization.

8. The aqueous solution of AAT as described in claim 7, wherein said aerosol composition comprises less than a 30% increase in the percentage of high molecular weight species after nebulization.

9. The aqueous solution of AAT as described in claim 1, wherein the temperature in the reservoir during nebulization does not exceed about 47 degrees C to about 55 degrees C.

10. The aqueous solution of AAT as described in claim 1, wherein the nebulization time is between about 5 to 15 minutes.

11. A method for treating pulmonary diseases which comprises administering to a subject in need thereof a therapeutically effective amount of the aqueous solution of AAT of claim 1.

12. The method of claim 11, wherein the pulmonary disease is selected from the group consisting of alpha 1-antitrypsin deficiency (AATD), chronic obstructive pulmonary disease (COPD), small airway disease, chronic bronchitis, emphysema, , bronchiectasis, cystic fibrosis, asthma, pneumonia, parenchymatic and fibrotic lung diseases or disorders, interstitial pulmonary fibrosis, and sarcoidosis.

13. The method of claim 11, wherein the aqueous solution of AAT is absorbed by lung tissues of the subject.

14. The method of claim 11, wherein the AAT is naturally occurring AAT purified from an unpurified mixture of proteins by a process comprising of chromatography on a plurality of ion exchange resins, comprising a first anion exchange resin followed by a cation and a second anion exchange resins.

15. The method of claim 11, wherein the AAT is recombinant or transgenic AAT.

16. The method of claim 11, wherein the method results in: reduced hospitalization; reduced intensive care or mechanical ventilation need; reduced healthcare utilization or burden; reduced absences from school or work; decreased antibiotic need; decreased steroid need; decreased relapse frequency; and decreased morbidity.