Dry Powder Inhaler of Colistimethate Sodium for Lung Infections in Cystic Fibrosis: Optimization of Powder Construction.

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F67985858%3A_____%2F19%3A00507425" target="_blank" >RIV/67985858:_____/19:00507425 - isvavai.cz</a>

Výsledek na webu

<a href="http://hdl.handle.net/11104/0299807" target="_blank" >http://hdl.handle.net/11104/0299807</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/03639045.2019.1652636" target="_blank" >10.1080/03639045.2019.1652636</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Dry Powder Inhaler of Colistimethate Sodium for Lung Infections in Cystic Fibrosis: Optimization of Powder Construction.

Popis výsledku v původním jazyce

Colistimethate sodium (CMS) for treatment of lung infections in cystic fibrosis patient was transformed into a dry powder for inhalation by spray drying. Design of Experiment was applied for understanding the role of the spray drying process parameters on the critical quality attributes of the CMS spray-dried powders (SD) and agglomerates thereof. Eleven experimental SD microparticle powders were constructed under different process conditions according to a Central Composite Design. The SD microparticles were then agglomerated in soft pellets. Eleven physico-chemical characteristics of SD CMS microparticle powders or agglomerates thereof were selected as critical quality attributes.nThe yield of SD process was higher than 75%. The emitted fraction of agglomerates from RS01 inhaler was 75-84%, and the fine particle fraction (particles <5 µm) between 58-62%. The quality attributes of CMS SD powders and respective agglomerates that were significantly influenced by spray drying process parameters were residual solvent and drug content of the SD microparticles as well as bulk density and respirable dose of the agglomerates. These attributes were also affected by the combination of the process variables. The air aspiration rate was found as the most positively influential on drug and solvent content and respirable dose. The residual solvent content significantly influenced the powder bulk properties and aerodynamic behavior of the agglomerates, i.e. quality attributes that govern drug metering in the device and the particles lungs deposition. Agglomerates of colistimethate sodium SD microparticles, in combination with RS01 DPI, showed satisfactory results in terms of dose emitted and fine particle fraction.

Název v anglickém jazyce

Dry Powder Inhaler of Colistimethate Sodium for Lung Infections in Cystic Fibrosis: Optimization of Powder Construction.

Popis výsledku anglicky

Colistimethate sodium (CMS) for treatment of lung infections in cystic fibrosis patient was transformed into a dry powder for inhalation by spray drying. Design of Experiment was applied for understanding the role of the spray drying process parameters on the critical quality attributes of the CMS spray-dried powders (SD) and agglomerates thereof. Eleven experimental SD microparticle powders were constructed under different process conditions according to a Central Composite Design. The SD microparticles were then agglomerated in soft pellets. Eleven physico-chemical characteristics of SD CMS microparticle powders or agglomerates thereof were selected as critical quality attributes.nThe yield of SD process was higher than 75%. The emitted fraction of agglomerates from RS01 inhaler was 75-84%, and the fine particle fraction (particles <5 µm) between 58-62%. The quality attributes of CMS SD powders and respective agglomerates that were significantly influenced by spray drying process parameters were residual solvent and drug content of the SD microparticles as well as bulk density and respirable dose of the agglomerates. These attributes were also affected by the combination of the process variables. The air aspiration rate was found as the most positively influential on drug and solvent content and respirable dose. The residual solvent content significantly influenced the powder bulk properties and aerodynamic behavior of the agglomerates, i.e. quality attributes that govern drug metering in the device and the particles lungs deposition. Agglomerates of colistimethate sodium SD microparticles, in combination with RS01 DPI, showed satisfactory results in terms of dose emitted and fine particle fraction.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

<a href="/cs/project/LTC17010" target="_blank" >LTC17010: Studie účinnosti dodávky léků dávkovaných aerosolovými inhalátory na cílové místo v dýchacím ústrojí</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2019

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Drug Development and Industrial Pharmacy

ISSN

0363-9045

e-ISSN

—

Svazek periodika

45

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

1664-1673

Kód UT WoS článku

000484270800001

EID výsledku v databázi Scopus

2-s2.0-85071386908