Budesonide aerosol preparation with hydrofluoroalkane used as propellant

26-03-2014 дата публикации
Номер:
CN103655473A
Принадлежит: JIANGSU CHANGFENG PHARMACEUTICAL CO Ltd
Контакты:
Номер заявки: 70-10-20130042
Дата заявки: 27-10-2011



[1]

The invention discloses a budesonide aerosol. The aerosol comprises budesonide, granular drugs of physiologically acceptable salt and solvate of the budesonide and a hydrofluoroalkane propellant; optionally, the aerosol does not contain a surfactant basically; and optionally, the aerosol does not contain a co-solvent with the polarity higher than that of the propellant basically. Experimental results indicate that the aerosol is a medical aerosol good in stability.



1. Budesonide aerosol, which comprises:

Budesonide and its physiologically acceptable salt of the micronised and solvolyte particulate drug;

Propellant hydrofluoroalkanes;

The basic and higher than the propellant does not contain the polarity of the polarity of the co-solvent, or containing surface-active agent;

Wherein the micronized particulate medicament aerosol of the 0.01-5% W/W;

90% W/W of the particulate medicament is less than the diameter of the 5  m, 50% W/W of the particulate medicament is less than the diameter of the 3  m.

2. If the right of the aerosol, wherein the micronized particulate medicament aerosol of the 0.01-3% w/w.

3. Aerosol according to Claim 1, wherein by the airstream grinding particulate medicament.

4. Aerosol according to Claim 1, wherein the propellant is 1, 1, 1, 2-tetrafluoroethane or 1, 1, 1, 2, 3, 3, 3- seven fluorine are positive propane or mixtures thereof.

5. Budesonide aerosol, is prepared from the following components:

The aerosol of the 0.01-5% W/W of the budesonide and its physiologically acceptable salt of the micronised and solvolyte particulate drug;

Propellant hydrofluoroalkanes and;

Wherein 90% W/W of the particulate medicament is less than the diameter of the 5  m, 50% W/W of the particulate medicament is less than the diameter of the 3  m.

6. Budesonide aerosol, is prepared from the following components:

The aerosol of the 0.01-5% W/W of the budesonide and its physiologically acceptable salt of the micronised and solvolyte particulate drug;

Propellant hydrofluoroalkanes;

Preparation of not more than and 1% W/W of a surfactant;

Wherein 90% W/W of the particulate medicament is less than the diameter of the 5  m, 50% W/W of the particulate medicament is less than the diameter of the 3  m.

7. Budesonide aerosol, is prepared from the following components:

The aerosol of the 0.01-5% W/W of the budesonide and its physiologically acceptable salt of the micronised and solvolyte particulate drug;

Propellant hydrofluoroalkanes;

Is not greater than and propellant 0.5% W/W the polarity of the polarity of the co-solvent is higher than the propellant;

Wherein 90% W/W of the particulate medicament is less than the diameter of the 5  m, 50% W/W of the particulate medicament is less than the diameter of the 3  m.

8. To 7 a according to Claim 5 of the aerosol, wherein the aerosol of accounts for 0.01-3% W/W of the budesonide and its physiologically acceptable salt of the micronised and solvolyte particulate drug.

9. Comprising -8 a in the aerosol can of aerosol according to Claim 1, which comprises a can bear the aerosol vapor pressure of the container, the container is provided with a metering valve nozzle, the nozzle has a diameter of 0.2-0.6 mm.

10. The aerosol canister according to Claim 9, which comprises a can bear the aerosol vapor pressure of the container, the container is provided with a metering valve nozzle, the nozzle has a diameter of 0.3-0.5 mm.