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Stearic acid and high molecular weight PEO as matrix for the highly water soluble metoprolol tartrate in continuous twin-screw melt granulation Hasselt University Ghent University
Granules with release-sustaining properties were developed by twin screw hot melt granulation (HMG) using a combination of stearic acid (SA) and high molecular weight polyethylene oxide (PEO) as matrix for a highly water soluble model drug, metoprolol tartrate (MPT). Earlier studies demonstrated that mixing molten SA and PEO resulted in hydrogen bond formation between hydroxyl groups of fatty acid molecules and ether groups in PEO chains. These ...
Model-based characterisation of twin-screw granulation system for continuous solid dosage manufacturing Ghent University
Continuous twin-screw granulation has received increased attention as it can be embedded in a continuous manufacturing line allowing 24/7 production capacity eliminating scale-up requirements and intermediate storage. The screws have a modular structure (interchangeable transport and kneading discs) allowing greater flexibility in equipment design. However, process knowledge should be further developed both under steady state and dynamic ...
Development and evaluation of a continuous granulation technique using a twin-screw extruder Ghent University
The term granulation refers to a process of size-enlargement, whereby primary powder particles are gathered into larger, semi-permanent aggregates (granules) in which the original particles still can be identified. The main reasons for granulation in the pharmaceutical industry are to prevent segregation of the constituents of the powder mix and to improve the flow properties and compaction characteristics of the mix. The most commonly used ...
TPLS as predictive platform for twin-screw wet granulation process and formulation development Ghent University
In recent years, the interest in continuous manufacturing techniques, such as twin-screw wet granulation, has increased. However, the understanding of the influence of the combination of raw material properties and process settings upon the granule quality attributes is still limited. In this study, a T-shaped partial least squares (TPLS) model was developed to link raw material properties, the ratios in which these raw materials were combined ...
In-line temperature measurement to improve the understanding of the wetting phase in twin-screw wet granulation and its use in process development Ghent University
Wetting is the initial stage of wet granulation processes during which the first contact between the powder and the liquid occurs. Wetting is a critical step to allow granule growth and consolidation, but also to ensure uniform active pharmaceutical ingredient (API) distribution over all granule size fractions. A physical understanding of the wetting stage is therefore crucial to design a robust granulation process. In twin-screw granulation, ...
Comparison of two twin-screw extruders for continuous granulation Ghent University
A comparison was made between two twin-screw extruders (APV Baker and Leistritz Micro) used for continuous wet granulation. Both extruders had similar screw configurations, based on the length-to-diameter ratio of the screws, existing out of a conveying zone of 20 D, i.e. 20 times the screw diameter and a granulation zone of 4 D. The kneading blocks in the granulation zone were 2.2 and 2.5 D for the Leistritz and APV extruders, respectively. An ...
Experimental investigation of granule size and shape dynamics in twin-screw granulation Ghent University
Heat transfer evaluation during twin-screw wet granulation in view of detailed process understanding Ghent University
During the last decade, the pharmaceutical industry has shown a growing interest in continuous twin-screw granulation (TSG). Despite flourishing literature on TSG, limited studies focused on fundamental process understanding on its mechanisms. In current study, granule quality attributes along the length of the TSG barrel were evaluated together with heat transfer in order to achieve a more fundamental understanding of the granulation process. ...
T-shaped partial least squares for high-dosed new active pharmaceutical ingredients in continuous twin-screw wet granulation : granule size prediction with limited material information Ghent University
This work presents a granule size prediction approach applicable to diverse formulations containing new active pharmaceutical ingredients (APIs) in continuous twin-screw wet granulation. The approach consists of a surrogate selection method to identify similar materials with new APIs and a T-shaped partial least squares (T-PLS) model for granule size prediction across varying formulations and process conditions. We devised a surrogate material ...