Search Results - "Stauffer, Fanny"
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A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules
Published in Journal of pharmaceutical sciences (01-03-2017)“…Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT)…”
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Analysis of the Influence of Process and Formulation Properties on the Drying Behavior of Pharmaceutical Granules in a Semi-Continuous Fluid Bed Drying System
Published in Powders (04-04-2023)“…In the last decade, twin-screw wet granulation became an essential technology for continuous pharmaceutical tablet production. Consequently, interest in…”
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Sampling and diversion strategy for twin-screw granulation lines using batch statistical process monitoring
Published in European journal of pharmaceutical sciences (01-04-2022)“…Continuous manufacturing is now considered as a well-established technique by pharmaceutical companies. However, the limited number of filed applications…”
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Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation
Published in International journal of pharmaceutics (25-06-2023)“…[Display omitted] In recent years, continuous twin-screw wet granulation (TSWG) is gaining increasing interest from the pharmaceutical industry. Despite the…”
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Mechanistic modeling of semicontinuous fluidized bed drying of pharmaceutical granules by incorporating single particle and bulk drying kinetics
Published in International journal of pharmaceutics (05-11-2023)“…In this work, a mechanistic fluidized bed drying model computing the granule moisture content in function of granule size, drying time, process settings and…”
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Exploring the effect of raw material properties on continuous twin-screw wet granulation manufacturability
Published in International journal of pharmaceutics (15-10-2023)“…[Display omitted] Twin-screw wet granulation (TSWG) stands out as a promising continuous alternative to conventional batch fluid bed- and high shear wet…”
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Analysis of the effect of formulation properties and process parameters on granule formation in twin-screw wet granulation
Published in International journal of pharmaceutics (25-01-2024)“…In the last few years, twin-screw wet granulation (TSWG) has become one of the key continuous pharmaceutical unit operations. Despite the many studies that…”
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Model-Guided Development of a Semi-Continuous Drying Process
Published in Pharmaceutical research (01-09-2022)“…Introduction With an increased adoption of continuous manufacturing for pharmaceutical production, the ConsiGma® CTL25 wet granulation and tableting line has…”
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Model development and calibration of two-dimensional population balance model for twin-screw wet granulation based on particle size distribution and porosity
Published in Powder technology (01-04-2023)“…Population balance models (PBMs) have been widely studied for the simulation of continuous twin-screw wet granulation. Due to the limited data availability and…”
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Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey
Published in Pharmaceutical research (01-09-2024)“…Purpose The concept of a Design Space (DSp) was introduced in ICH Q8 as a tool within the quality-by-design (QbD) approach to pharmaceutical development with…”
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Predicting powder feedability: A workflow for assessing the risk of flow stagnation and defining the operating space for different powder-feeder combinations
Published in International journal of pharmaceutics (15-12-2022)“…[Display omitted] •Extensive material and feeder characterization for ten pharmaceutical powders and four different feeders.•First time introduction of feeder…”
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Heat Transfer Evaluation During Twin-Screw Wet Granulation in View of Detailed Process Understanding
Published in AAPS PharmSciTech (01-10-2019)“…During the last decade, the pharmaceutical industry has shown a growing interest in continuous twin-screw granulation (TSG). Despite flourishing literature on…”
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Validation of model-based design of experiments for continuous wet granulation and drying
Published in International journal of pharmaceutics (05-11-2023)“…This paper presents an application case of model-based design of experiments for the continuous twin-screw wet granulation and fluid-bed drying sequence. The…”
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Partial least squares regression to calculate population balance model parameters from material properties in continuous twin-screw wet granulation
Published in International journal of pharmaceutics (10-06-2023)“…In the pharmaceutical industry, twin-screw wet granulation has become a realistic option for the continuous manufacturing of solid drug products. Towards the…”
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Control strategy definition for a drug product continuous wet granulation process: Industrial case study
Published in International journal of pharmaceutics (25-08-2022)“…[Display omitted] This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based…”
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Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective
Published in Drug discovery today (01-04-2020)“…•Continuous processing represents new challenges in pharmaceutical material science.•Critique of key process steps such as feeding on product quality has…”
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Linking material properties to 1D-PBM parameters towards a generic model for twin-screw wet granulation
Published in Chemical engineering research & design (01-05-2023)“…Population balance models (PBM) have been widely used to model the twin-screw wet granulation (TSWG) in the continuous manufacturing of solid dosage forms…”
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