Process analytical technology tools for monitoring pharmaceutical unit operations: a control strategy for continuous process verification

EJ Kim, JH Kim, MS Kim, SH Jeong, DH Choi - Pharmaceutics, 2021 - mdpi.com
Various frameworks and methods, such as quality by design (QbD), real time release test
(RTRT), and continuous process verification (CPV), have been introduced to improve drug …

A review of high shear wet granulation for better process understanding, control and product development

B Liu, J Wang, J Zeng, L Zhao, Y Wang, Y Feng… - Powder Technology, 2021 - Elsevier
High shear wet granulation (HSWG) is considered a complicated and multivariate
pharmaceutical process that is influenced by a large number of variables derived from …

Twin screw wet granulation: Influence of formulation parameters on granule properties and growth behavior

AS El Hagrasy, JR Hennenkamp, MD Burke… - Powder technology, 2013 - Elsevier
This study investigated the effect of formulation parameters on granule properties and
growth behavior using a 16mm twin screw granulator. A model placebo formulation …

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 …

Quality by design for wet granulation in pharmaceutical processing: assessing models for a priori design and scaling

D Kayrak-Talay, S Dale, C Wassgren, J Litster - Powder technology, 2013 - Elsevier
The effective implementation of Quality by Design (QbD) for wet granulation requires
quantitative models for design and scaling of granulators. This paper reviews that current …

Granule size distributions after twin-screw granulation–do not forget the feeding systems

R Meier, M Thommes, N Rasenack, KP Moll… - European Journal of …, 2016 - Elsevier
The aim of this study was to investigate the influence of qualitatively different powder feeder
performances on resulting granule size distributions after twin-screw granulation of a highly …

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 …

A regime map for granule formation by drop impact on powder beds

HN Emady, D Kayrak‐Talay, JD Litster - AIChE Journal, 2013 - Wiley Online Library
“T unneling,”“S preading,” and “C rater F ormation” are the three granule formation
mechanisms known to occur when single drops impact static powder beds. To quantify the …

A combined experimental and modeling approach to study the effects of high-shear wet granulation process parameters on granule characteristics

P Pandey, J Tao, A Chaudhury… - Pharmaceutical …, 2013 - Taylor & Francis
The purpose of the current work is to study the effects of high-shear wet granulation process
parameters on granule characteristics using both experimental and modeling techniques. A …

[HTML][HTML] Smart process manufacturing for formulated products

J Litster, IDL Bogle - Engineering, 2019 - Elsevier
We outline the smart manufacturing challenges for formulated products, which are typically
multicomponent, structured, and multiphase. These challenges predominate in the food …