Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment
J Djuris, Z Djuric - International journal of pharmaceutics, 2017 - Elsevier
Mathematical models can be used as an integral part of the quality by design (QbD) concept
throughout the product lifecycle for variety of purposes, including appointment of the design …
throughout the product lifecycle for variety of purposes, including appointment of the design …
Trends-process analytical technology in solid oral dosage manufacturing
L Zhong, L Gao, L Li, H Zang - European Journal of Pharmaceutics and …, 2020 - Elsevier
Quality is the lifeline for all pharmaceuticals. Process analytical technology (PAT),
introduced by FDA in 2004, providing significant opportunities for improving pharmaceutical …
introduced by FDA in 2004, providing significant opportunities for improving pharmaceutical …
CFD–DEM–PBM coupled model development and validation of a 3D top-spray fluidized bed wet granulation process
In pharmaceutical manufacturing, fluidized bed granulation is one of the common
processing options available to achieve better flowability of powders through size …
processing options available to achieve better flowability of powders through size …
High shear seeded granulation: Its preparation mechanism, formulation, process, evaluation, and mathematical simulation
R Maharjan, SH Jeong - Powder Technology, 2020 - Elsevier
Seeded granulation is one of the recently adopted wet granulation techniques. The seeded
granules consist of high-density core nuclei and low-density particles layered on the outside …
granules consist of high-density core nuclei and low-density particles layered on the outside …
Drying capacity of a continuous vibrated fluid bed dryer–Statistical and mechanistic model development
H Wikström, LM de Juan, J Remmelgas, R Meier… - International Journal of …, 2023 - Elsevier
The drying capacity of a continuous vibrated fluid bed dryer was studied using a DoE by
varying microcrystalline cellulose content in the formulation, water amount in the twin-screw …
varying microcrystalline cellulose content in the formulation, water amount in the twin-screw …
Model-driven design using population balance modelling for high-shear wet granulation
Abstract Model-driven design approaches have great potential to improve current
engineering workflows for wet granulation and other particulate processes. The key to model …
engineering workflows for wet granulation and other particulate processes. The key to model …
Product development, manufacturing, and packaging of solid dosage forms under QbD and PAT paradigm: DOE case studies for industrial applications
BN Singh - AAPS PharmSciTech, 2019 - Springer
An integrated approach based on QbD and PAT provides a systematic and innovative
framework for product development, manufacturing, and quality risk management. In this …
framework for product development, manufacturing, and quality risk management. In this …
[HTML][HTML] Industrial application of heat-and mass balance model for fluid-bed granulation for technology transfer and design space exploration
This work demonstrates the application of state-of-the-art modeling techniques in
pharmaceutical manufacturing for fluid bed granulation at varying scales to successfully …
pharmaceutical manufacturing for fluid bed granulation at varying scales to successfully …
Modeling, experimental trials, and design space determination for the GEA ConsiGma™ coater
IC Kemp, L Iler, M Waldron, N Turnbull - Drying Technology, 2019 - Taylor & Francis
ABSTRACT A mechanistic model was developed for tablet coating and applied successfully
to the novel GEA ConsiGma™ coater. The majority of the heat for evaporation is supplied by …
to the novel GEA ConsiGma™ coater. The majority of the heat for evaporation is supplied by …
Application of mechanistic drying models in pharmaceuticals and other industries
IC Kemp - Drying Technology, 2019 - Taylor & Francis
The criteria for application of models in industry are based on the relevance of the results
obtained for the needs of the project.“Fitness for purpose” is key. A model should be at the …
obtained for the needs of the project.“Fitness for purpose” is key. A model should be at the …