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Clickhaler dry powder inhaler: focussed in vitro proof of principle evaluation of a new chemical entity for asthma.

Abstract：

:A new chemical entity (NCE) was evaluated in the Clickhaler (Innovata Biomed Ltd.) dry powder inhaler, a reservoir-based multidose delivery system. The standard device metering system was modified to handle higher doses (nominally 20 mm(3) of lactose based blend). The micronized drug was formulated at 12.5% w/w in lactose monohydrate (Pharmatose 325M, DMV) equivalent to a nominal dose of approximately 1 mg. Delivered shot weight (mg of blend) and emitted dose (microg drug) averaged 7.4 mg and 905 microg, respectively, and were consistent (within +/-20 to 25% of mean) through the life of the inhaler. The fine particle fraction (FPF) (Andersen cascade impactor) was typically 60%. A short stability study (i.e. 3 months at room temperature, 53 or 75% RH, unpacked) showed that the in vitro performance was maintained. The results of these studies provide in vitro proof of principle for this novel drug/device combination.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Thibert R,Parry-Billings M,Shott M

doi

10.1016/s0378-5173(02)00106-0

keywords:

subject

Has Abstract

pub_date

2002-06-04 00:00:00

pages

149-56

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378517302001060

journal_volume

239

pub_type

杂志文章

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