PubMed · 13733015
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J PARSONS, W T BEHER, G D BAKER. 1961. X-ray diffraction powder data for steroids.. https://pubmed.ncbi.nlm.nih.gov/13733015/
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The Peschl-split bed shear tester was utilised to study the formation of different liquid states during wet massing for granulation. Using lactose monohydrate as a model bulking agent the threshold between pendular and funicular state was found to be at about 6% (w/w) of liquid binder added to the wet mass, here a 5% colloidal solution of HPMC in water. The upper limit of the funicular state appeared to be at approximately 15% (w/w) of liquid binder. The threshold values obtained from the shear cell measurements did correlate with values obtained from dried granule characteristics such as granule density and compressive Young's modulus determined by Dynamic Mechanical Analysis. The compressive Young's modulus increased with an increasing density of the wet mass during the shear experiments and decreased with an increase in the angle of internal friction. The results suggest that stiffer granules were a result of densification, not the strength of liquid bridge bond formation.
The scaling up of a fluidized bed granulation process from small scale to production scale is often done empirically in the pharmaceutical industry. In this study, a more practical and systematic method was developed in order to achieve a similar granule size in the scaled up fluid bed. The scaling up is based on the relative droplet size, and the powder bed moisture content at the end of the spraying cycle. The present study describes the scaling up of the fluidized granulation process from small (5 kg scale) to medium (30 kg scale) and to production fluid bed scale (120 kg scale). The granulation process is scaled up with as target a geometric mean granule size of 400 microm. First, the effect of the relative droplet size on the granule size was investigated in the different fluid beds. The effect of the change in relative droplet size on the granule size was different for each fluid bed. Second, experimental design is applied on the small and the medium fluid scale, and regression models for the granule size are proposed in order to scale up the granulation process on the small to medium scale. The granulation process was also successful by scaling-up to the large fluid bed, considering only the relative droplet size.
We use a variety of experimental results to illustrate issues and challenges involved in the sampling and characterization of pharmaceutical mixtures. Accurate and reliable characterization of granular mixtures is hindered by both the complexity of granular systems and the lack of validated and reliable sampling technology and techniques. Both sampling tools and sampling protocols are critically important for accurate characterization. Using cohesive and free-flowing powders and four thief probe designs, we reveal a large potential for extremely misleading results as well as severe disturbance of the granular bed. We also discuss results from several experiments designed to test the validity of various sampling protocols by varying parameters such as sampling location and frequency of sampling. These experiments illustrate the importance of effective sampling procedures to achieve the best and most efficient results.