Manufacturing DPIs: an engineering perspective
Pietro Piera1 & Mathieu Pfeiffer2
IMA S.p.A., Via Emilia 428-442, 40064 Ozzano dell’Emilia (BO), Italy
Summary
When developing new pharmaceutical products in DPI form, industrial manufacturing aspects must be considered from the very beginning to shorten the scale-up and optimization of the final manufacturing process, as well as to achieve a more efficient and cost effective production. Precise micro-dosing, weight control, containment measures and ease of device assembly are all issues that must be faced at an early stage.
IMA draws on its extensive expertise to provide the most advanced solutions for DPI processing and assembly. Direct weight control performed in line on each single capsule or device, both before and after filling. Absence of mechanical powder compression for improved airway intake. Accurate micro-dosing and automatic feedback and adjustment. Highly flexible and precise inhaler assembly in accordance with design for manufacturing (DFM) and proof of principle studies at an early stage.
This presentation investigates optimal process parameters for low-dose DPIs achieved by the dosator technology. The study proves that a major advantage of using this technology for processing DPIs is that the dosators can be accurately adjusted without any need to compress or aspirate the powder. Maintaining the free-flowing properties of the dispended powder within the capsule better ensures the release of powder from the capsule into the inhaler when the capsule is pierced, thereby better controlling both the emitted dose and the fine particle fraction of the dose discharged from the DPI.