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In vitro nebulization characteristics of budesonide suspension for inhalation
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Miao LI1, Ning-yi WEI2, Jing ZHENG2, 3, Ju-jiao YAN1, Lu CHEN1, Jin-tao LU1, Bao-ming NING2, *
Acta Pharmaceutica Sinica | 2021, 56(10) : 2669 - 2675
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Acta Pharmaceutica Sinica | 2021, 56(10): 2669-2675
• Special Reports: Inhalation Drug Delivery System •
In vitro nebulization characteristics of budesonide suspension for inhalation
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Miao LI1, Ning-yi WEI2, Jing ZHENG2, 3, Ju-jiao YAN1, Lu CHEN1, Jin-tao LU1, Bao-ming NING2, *
Affiliations
  • 1. NMPA Key Laboratory for Quality Research and Control of Drug Products, Wuhan Institute for Drug and Medical Device Control, Wuhan 430075, China
  • 2. National Institutes for Food and Drug Control, Beijing 102629, China
  • 3. School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China
Published: 2021-10-12 doi: 10.16438/j.0513-4870.2021-0309
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We established in vitro evaluation methods of the nebulization characteristics of budesonide suspension for inhalation and analyzed the influence factors. The delivery rate and total drug substance delivered (TDD) of two manufacturers were determined by using the breath simulator with different nebulizers. The aerodynamic particle size distribution was investigated by next generation impactor (NGI) and HPLC as well. The fine particle dose (FPD), the mass median aerodynamic diameter (MMAD), the delivery rate and TDD results of the same sample with different nebulizers were significantly different (P < 0.01), mainly due to the different design parameters of the nebulizers. The FPD of two samples were significantly different (P < 0.01) by the same nebulizers, probably due to differences in physical and chemical properties differences such as suspension particle size. The analysis method of nebulization characteristics provided in this paper can be used to select the nebulization device with appropriate delivery dose and aerodynamic particle size distribution (APSD) for different inhalation liquid preparations in clinical practice, and can also be used as the guidance for the selection of nebulization device and analysis method in the research and development of generic inhalation liquid preparations and quality consistency evaluation.

budesonide suspension for inhalation  /  aerodynamic particle size distribution  /  delivery rate  /  total drug substance delivered
Miao LI, Ning-yi WEI, Jing ZHENG, Ju-jiao YAN, Lu CHEN, Jin-tao LU, Bao-ming NING. In vitro nebulization characteristics of budesonide suspension for inhalation[J]. Acta Pharmaceutica Sinica, 2021 , 56 (10) : 2669 -2675 . DOI: 10.16438/j.0513-4870.2021-0309
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Article Info
doi: 10.16438/j.0513-4870.2021-0309
  • Receive Date：2021-03-03
  • Online Date：2025-12-18
  • Published：2021-10-12
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History
  • Received：2021-03-03
  • Revised：2021-04-27
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Affiliations
    1. NMPA Key Laboratory for Quality Research and Control of Drug Products, Wuhan Institute for Drug and Medical Device Control, Wuhan 430075, China
    2. National Institutes for Food and Drug Control, Beijing 102629, China
    3. School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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