Annalisa Bianchera1, Ayça Altay-Benetti1, Francesca Buttini1, Pietro Pirera2 & Ruggero Bettini1
1Food and Drug Department, University of Parma, Parco Area delle Scienze 27/a, Parma, 43124, Italy
2 I.M.A. Industria Macchine Automatiche S.p.A. Unipersonale, Via Emilia 428-442, 40064 Ozzano dell’Emilia (Bologna), Italy
Summary
Material characteristics and filling process have significant consequences on aerosolization performances of DPIs. Different settings of a bench-capsule filler, Minima®, were compared by means of a design of experiment to identify most significant parameters affecting capsule weight among bed powder height, compression and dosage volume. Four types of lactose were used as coarse fraction in binary mixtures with micronized lactose to simulate low dosage API for inhalation. Mixtures with three dosages of fine lactose, namely 2%, 5% or 10%, were prepared for filling capsules, to study aerosolization behaviour of low-dose DPI products, which are of particular interest for lung administration. Data indicate that Minima® provides consistent results, in terms of weight and repeatability. Compression was identified as the main parameter affecting both final weight and emitted fraction after capsule discharging by DPI RS01. On the other hand, the type of raw material mainly influences the fine particle fraction, with Lacto-Sphere® MM50 showing the best performances, with the 2% of fine lactose.
Key Message
The effect of capsule filling parameters on emitted dose and fine particle fraction by a DPI was investigated using a table-top device for capsule filling. Compression was the parameter that affected weight and emitted fraction the most, while the type of coarse lactose seems to influence the fine particle fraction.