Ten Years of the Manufacturing Classification System: A review of literature applications and an extension of the framework to continuous manufacture

M Leane, K Pitt, G Reynolds, A Tantuccio… - Pharmaceutical …, 2024 - Taylor & Francis
The MCS initiative was first introduced in 2013. Since then, two MCS papers have been
published: the first proposing a structured approach to consider the impact of drug …

[HTML][HTML] Using AI/ML to predict blending performance and process sensitivity for Continuous Direct Compression (CDC)

O Jones-Salkey, CRK Windows-Yule, A Ingram… - International Journal of …, 2024 - Elsevier
Utilising three artificial intelligence (AI)/machine learning (ML) tools, this study explores the
prediction of fill level in inclined linear blenders at steady state by mapping a wide range of …

Planetary roller melt granulation (PRMG)–A new continuous method for powder processing

D Nesges, T Lang, T Birr, M Thommes, J Bartsch - Powder Technology, 2023 - Elsevier
For the continuous operation of granulation, which is a standard unit operation in powder
processing to modify the particle size, the use of twin-screw machines was established as …

[HTML][HTML] Impact of material properties and process parameters on tablet quality in a continuous direct compression line

PHM Janssen, S Fathollahi, B Bekaert, D Vanderroost… - Powder Technology, 2023 - Elsevier
The current paper shows how excipient properties impact the process parameters and the
final tablet properties in a fully integrated continuous direct compression line. Blend …

Manufacturing process transfer to a 30 kg/h continuous direct compression line with real-time composition monitoring

A Waněk, L Menarini, F Giatti, T Kubelka… - International Journal of …, 2024 - Elsevier
Transferring an existing marketed pharmaceutical product from batch to continuous
manufacturing (CM) without changes in regulatory registration is a challenging task in the …

[HTML][HTML] Adapting the process conditions and performance in planetary roller melt granulation (PRMG) via the planetary spindle number

T Lang, J Bartsch - Powder Technology, 2024 - Elsevier
Continuous melt granulation with a planetary roller granulator is a new continuous method
based on the orbital motion of planetary spindles driven by a rotating central spindle in a …

Cleaning of direct compression continuous manufacturing equipment through displacement of API residues by excipients

DS Patel, R Méndez, RJ Romañach - International Journal of …, 2024 - Elsevier
This feasibility study evaluates a cleaning process designed to avoid the use of detergents
and reduce operator exposure to the active pharmaceutical ingredient (API). The continuous …

[HTML][HTML] Batch vs. continuous direct compression–a comparison of material processability and final tablet quality

B Bekaert, PHM Janssen, S Fathollahi… - International Journal of …, 2024 - Elsevier
In this study, an in-depth comparison was made between batch and continuous direct
compression using similar compression set-ups. The overall material processability and final …

Time Series Analysis in Drug Product Development and Statistical Forecasting

BJ Johnson - 2022 - search.proquest.com
The statistical discipline of time series analysis excels at modeling and forecasting the
dynamics of complex systems that exhibit non-random correlations between successive …

[PDF][PDF] Разработка состава и технологии суппозиториев с эналаприла малеатом

А Зингад - 2023 - dspace.nuph.edu.ua
Квалификационная работа содержит 42 страницы, 3 таблицы, 12 рисунков, список
литератури з 54 наименований. С целью разработки состава и технологии …