Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 516, Issue 1-2, Pages 9-20Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2016.11.010
Keywords
Low-dose capsule filling; Dosator nozzle machine; Inhalation powders; Powder bed uniformity
Categories
Funding
- Austrian COMET Program under the Austrian Federal Ministry of Transport, Innovation and Technology (bmvit)
- Austrian Federal Ministry of Economy, Family and Youth (bmwfj)
- State of Styria (Styrian Funding Agency SFG)
- MG2, University of Ljubljana
- SES-Tec OG
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The objective of this work was to assess the effect of process parameters of a dosator nozzle machine on the powder bed uniformity of inhalation powders with various characteristics during a low-dose dosator capsule filling process. Three grades of lactose excipients were extensively characterized and filled into size 3 capsules using different dosing chamber lengths (2.5, 5 mm), nozzle diameters (1.9, 3.4 mm), powder bed heights (5, 10 mm) and filling speeds (500, 3000 capsules/h). The fill weight and the weight variability of Lactohale 100 (large particles, good flowability, low cohesion) remained almost the same, regardless of the process parameters throughout the capsule filling run time. Moreover, for this powder an increase in the fill weight at a higher filling speed was observed in all cases. Fill weight variability was significantly higher for lower dosing chamber volumes at a filling speed of 3000 capsules per hour. Lactohale 220 (small particles, poor flowability, high cohesion) delivered entirely different results. After a certain run time, depending on instrumental settings, a 'steady-state' with constant fill weights and low weight variability was achieved. For this highly cohesive powder, a high dosing chamber volume requires a low filling speed in order for the powder to completely fill the dosator nozzle. Moreover, it was established that a dosing chamber length of 2.5 mm and a powder bed height of 10 mm were required due to the powder's high fill weight variability over time, while the dosator size had no effect on it. In summary, the layer uniformity, the fill weight and the weight variability strongly depend on the powder characteristics and the instrumental settings. The results indicate that Lactohale 220 requires special attention during low-dose capsule filling. The study presents excellent insights into the effect of material attributes and process parameters on the layer uniformity and the quality of end product. (C) 2016 Elsevier B.V. All rights reserved.
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