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Granulation
Continuous twin screw granulation: Robustness of lactose/MCC-based formulations
In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response behavior…
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Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge…
The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous…
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Evaluation of an external lubrication system implemented in a compaction simulator
The internal blending of magnesium stearate is often associated with decreasing tensile strengths and longer disintegration and dissolution times. Therefore, external lubrication has gained interest in the pharmaceutical industry as these negative effects could be minimized using this method. In…
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Tablet Quality-Prediction Model Using Quality Material Attributes: Toward Flexible Switching Between…
Purpose
The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs).
Methods
Experiments were performed using ethenzamide as the active pharmaceutical…
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A review of regime maps for granulation
Granulation, a size enlargement technique to form agglomerates of primary particles, has proven to be effective in the production of solid dosage forms. Numerous granulation techniques can be applied, such as roll compaction, drum granulation, high shear granulation, twin-screw granulation or…
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Development of Low Dose Micro-tablets by High Shear Wet Granulation Process
Low dose micro-tablets with acceptable quality attributes, specifically content uniformity (CU), would not only enhance the dose flexibility in the clinic, but also decrease excipient burden in pediatric population. Considering the CU challenges associated with directly compressed low dose…
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From powder to tablets: Investigation of residence time distributions in a continuous manufacturing…
The essence of Continuous Manufacturing (CM) resides in the fact that continuous process units are directly connected to each other forming a continuous process train. The thorough understanding of material flow in this train based on suitable sensors, including on-line process analytical…
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In-line temperature measurement to improve the understanding of the wetting phase in twin-screw wet…
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…
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Tailored granule properties using 3D printed screw geometries in twin screw granulation
Twin screw granulation is becoming increasingly relevant due to its compact size, continuous and robust mode of operation, customizable design, and flexible production capacity. This work describes the experimental study undertaken to understand the dependence of granule properties on the screw…
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Compaction behavior of isomalt after roll compaction
Isomalt is a polyol derived from sucrose. Advantages of this excipient are its sweet taste, which is supposed to allow taste masking, the low glycemic and insulinemic response (Petzoldt, 1982), and the ability to be compacted directly. With regard to infantile patients, also the lack of…
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