Hot-melt extrusion: from theory to application in pharmaceutical formulation

H Patil, RV Tiwari, MA Repka - Aaps Pharmscitech, 2016 - Springer
Hot-melt extrusion (HME) is a promising technology for the production of new chemical
entities in the developmental pipeline and for improving products already on the market. In …

[HTML][HTML] Quality by design approach: Regulatory need

JN Sangshetti, M Deshpande, Z Zaheer… - Arabian Journal of …, 2017 - Elsevier
In this era of competition quality has been given prime magnitude; failure to meet such
quality allied goals produces massive shift of company in share of market. In this context …

Population balance modeling: current status and future prospects

D Ramkrishna, MR Singh - Annual review of chemical and …, 2014 - annualreviews.org
Population balance modeling is undergoing phenomenal growth in its applications, and this
growth is accompanied by multifarious reviews. This review aims to fortify the model's …

A comprehensive review on process and engineering aspects of pharmaceutical wet granulation

P Suresh, I Sreedhar, R Vaidhiswaran… - Chemical Engineering …, 2017 - Elsevier
Wet granulation is a very important unit operation that finds applications in many industries
mainly pharmaceutical and chemical industries. Various granulation technologies in batch …

A multi-scale, mechanistic model of a wet granulation process using a novel bi-directional PBM–DEM coupling algorithm

D Barrasso, T Eppinger, FE Pereira, R Aglave… - Chemical Engineering …, 2015 - Elsevier
In this study, a novel mechanistic model for a wet granulation process is presented,
combining the techniques of population balance modeling and discrete element methods to …

Model driven design for twin screw granulation using mechanistic-based population balance model

LG Wang, JP Morrissey, D Barrasso, D Slade… - International Journal of …, 2021 - Elsevier
This paper presents a generic framework of Model Driven Design (MDD) with its application
for a twin screw granulation process using a mechanistic-based population balance model …

A review of regime maps for granulation

S Pohl, P Kleinebudde - International Journal of Pharmaceutics, 2020 - Elsevier
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 …

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 …

Development of a process map: A step towards a regime map for steady-state high shear wet twin screw granulation

A Kumar, J Dhondt, J Vercruysse, F De Leersnyder… - Powder technology, 2016 - Elsevier
Twin-screw granulation is an emerging continuous granulation technique in the
pharmaceutical industry. The flexibility in process settings such as the binder addition …

A Quality by Design Approach to Scale-Up of High Shear Wet Granulation Process

P Pandey, SIF Badawy - Handbook of Pharmaceutical Wet Granulation, 2019 - Elsevier
High-shear wet granulation is a complex process that, in turn, makes scale-up a challenging
task. Scale-up of high-shear wet granulation process has been studied extensively in the …