Projects per year
Abstract
It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity of particle size distribution has been defined by the use of the d50 combined with the span of the particle size distribution, which has been found ineffective for polymodal particle size distributions. This work focuses on demonstrating the limitations of the span parameter to quantify homogeneity and proposes a novel improved metric based on the transformation of a typical particle size distribution curve into a homogeneity factor which can vary from 0 to 100%. The potential of this method as a characterisation tool has been demonstrated through its application to the production of granules using two different materials. The workspace of an 11 mm twin screw granulator was defined for two common excipients (α-lactose monohydrate and microcrystalline cellulose). Homogeneity of the obtained granules varied dramatically from 0 to 95 % in the same workspace, allowing identification of critical process parameters (e.g. feed rate, liquid/solid ratio, torque velocities). In addition it defined the operational conditions required to produce the most homogeneous product within the range 5 μm – 2.2 mm from both materials.
Original language | English |
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Pages (from-to) | 230-239 |
Number of pages | 10 |
Journal | International Journal of Pharmaceutics |
Volume | 519 |
Issue number | 1-2 |
Early online date | 16 Jan 2017 |
DOIs | |
Publication status | Published - 15 Mar 2017 |
Keywords
- twin screw granulation
- particle size distribution
- homogeneity factor
- quality by design
- granules
- powder
- liquid/solid ratio
Projects
- 1 Finished
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Doctoral Training Centre In Continuous Manufacturing And Crystallisation
EPSRC (Engineering and Physical Sciences Research Council)
1/07/12 → 30/06/19
Project: Research - Studentship