Performance indicators for carrier-based DPIs: Carrier surface properties for capsule filling and API properties for
E Faulhammer1, S Zellnitz1, T Wutscher1
1Research Center Pharmaceutical Engineering GmbH, Graz, 8010, Austria.
International Journal of Pharmaceutics
|December 9, 2017
Summary
Particle engineering impacts dry powder inhaler (DPI) performance. Carrier engineering improves capsule filling, while active pharmaceutical ingredient (API) engineering enhances lung dose delivery.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Particle Engineering
Background:
- Dry powder inhalers (DPIs) rely on specific particle properties for effective drug delivery.
- Both carrier and active pharmaceutical ingredient (API) particle engineering influence DPI performance.
Purpose of the Study:
- To differentiate the performance indicators of particle engineering for carrier-based DPIs.
- To assess the impact of engineered carriers versus engineered APIs on DPI performance.
Main Methods:
- Formulations of spray-dried (SDSS) and jet-milled (JMSS) salbutamol sulphate (SS) blended with untreated (LAC_R) and engineered (LAC_E) lactose monohydrate were prepared.
- Capsule filling was optimized using a dosator nozzle machine with varying process settings.
- In vitro lung deposition was evaluated using a next-generation impactor, calculating emitted dose (ED) and fine particle fraction (FPF).
Main Results:
- Micronized powder blends demonstrated a significantly higher FPF (20%) compared to spray-dried blends (5%).
- Carrier engineering positively affected capsule filling (weight variability, mean fill weight) at lower compression ratios.
- Higher compression ratios generally improved capsule filling performance.
Conclusions:
- Carrier properties primarily govern downstream processing, including capsule filling.
- API properties are critical for aerosolization performance and lung dose delivery.
- Distinct particle engineering strategies are required for optimizing carrier and API components in DPIs.
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