Briefly describe the quality requirements that powder inhalers should meet

Powder inhalers are devices that are micronized drugs or are stored with carriers in capsules, vesicles or multi-dose storage, and are actively inhaled by the patient into the lungs by the patient, and are designed with the diversity of the patient and the clinical environment in mind
.

So far, significant progress
has been made in the accuracy of fractionation, the effectiveness of powder dispersion, and the improvement of delivery efficiency.

Pre-load a certain dose in this device to make it easy for the patient to use; Easy to inhale at low doses; Dosage accuracy; Inhaled powder is insensitive to humidity, has good fluidity, and can also be inhaled with pure drugs without additives; Counting devices can prompt the patient to inhale the dose, there is no risk of overdose; Similar in weight and volume to aerosols (MDI) and reasonably priced
.

Today Xiaobian wants to share with you the quality requirements that the powder inhaler should meet: 1, the content uniformity and device difference Unless otherwise specified, capsule type or vesicle type powder spray should check these two items
.

(1) Content uniformity: according to the content uniformity testing method, it should comply with the regulations; (2) Difference in loading capacity: The average loading capacity is less than 0.
30g, and the limit of the difference in loading is ± 10%; The average filling size is 0.
30g or 0.
30g, the difference in the amount limit is ±7.
5% 2, the emptying rate capsule type or vesicle type powder spray should be checked, and the emptying rate should not be less than 90%.
3.
The total suction time of each bottle and the multi-dose storage type inhalation powder mist with the content of each main drug should be checked
.

(1) Total suction time per bottle: The total suction time of each bottle shall not be lower than the total suction time
of the logo.

(2) The content of the main drug per suction: the uniformity of the inhalation powder spray drug release is measured by the inhalation powder spray uniformity measurement device, and the content of the main drug per suction should be 65% to 135%
of the amount indicated in the content of the main drug per suction.

4.
Droplets (granules) distribution inhalation powder spray should check this item
.

According to the inhalation powder spray droplet (granule) distribution detection method, the amount of droplet (granule) drug should not be less than 10%
of the indicated amount of the main drug content per inhalation.

5.
The microbial limit is checked in accordance with the microbial limit inspection method and shall comply with the regulations
.