Product Lifecycle Approach to Cascade Impaction Measurements
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- 作者：Terrence P. Tougas (1)
Dave Christopher (2)
Jolyon Mitchell (3)
Svetlana Lyapustina (4)
Michiel Van Oort (5)
Richard Bauer (6)
Volker Glaab (7) - 关键词：abbreviated impactor measurement (AIM) ; Andersen cascade impactor (ACI) ; inhaler ; lifecycle ; quality control (QC)
- 刊名：AAPS PharmSciTech
- 出版年：2011
- 出版时间：March 2011
- 年：2011
- 卷：12
- 期：1
- 页码：312-322
- 全文大小：312KB
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Dave Christopher (2)
Jolyon Mitchell (3)
Svetlana Lyapustina (4)
Michiel Van Oort (5)
Richard Bauer (6)
Volker Glaab (7)
1. Analytical Development, Boehringer Ingelheim, Ridgefield, Connecticut, USA
2. Statistics, Merck, Kenilworth, New Jersey, USA
3. Trudell Medical International, London, Ontario, Canada
4. Pharmaceutical Practice Group, Drinker Biddle and Reath LLP, 1500 K Street NW, Washington, District of Columbia, 20005-1209, USA
5. Inhaled Product Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
6. Aerosol Analysis, MannKind Corp, Danbury, Connecticut, USA
7. Respiratory Drug Delivery, Boehringer Ingelheim, Ingelheim am Rhein, Germany
文摘
Over the lifecycle of an orally inhaled product (OIP), multi-stage cascade impactor (CI) measurements are used for different purposes and to address different questions. Full-resolution CIs can provide important information during product development and are widely used but are time- and resource-intensive, highly variable, and suboptimal for OIP quality control (QC) testing. By contrast, Efficient Data Analysis (EDA) combined with Abbreviated Impactor Measurement (AIM) systems pertinent either for QC and-/strong>possibly-/strong>for adult Human Respiratory Tract (pHRT) has been introduced for OIP performance assessment during and post-development. This article summarizes available evidence and discusses a strategy for using either abbreviated or full-resolution CI systems depending on the purpose of the measurement, such that adequate, accurate, and efficient testing of aerodynamic particle size distribution (APSD) of OIPs can be achieved throughout the lifecycle of a product. Under these proposals, a comprehensive testing program should initially be conducted by full-resolution CI in OIP development to ascertain the product’s APSD. Subsequently, correlations should be established from the selected AIM CIs to the corresponding full-resolution system, ideally developing specifications common to both techniques. In the commercial phase, it should be possible to release product using AIM/EDA, keeping the full-resolution CI for investigations, change control, and trouble-shooting, thus optimizing resources for APSD characterization throughout the product lifecycle. If an in vitro-em class="a-plus-plus">in vivo relationship is established and clinically relevant sizes are known, an AIM–pHRT could serve as a quick indicator that clinically relevant fractions have not changed and also, in the management of post-approval changes.