Rational formulation and industrial manufacturing of lipid-based complex injectables: Landmarks and trends

M Biscaia-Caleiras, NA Fonseca, AS Lourenço… - Journal of Controlled …, 2024 - Elsevier
Lipid-based complex injectables are renowned for their effectiveness in delivering drugs,
with many approved products. While significant strides have been made in formulating …

Recent development of optimization of lyophilization process

H Kawasaki, T Shimanouchi, Y Kimura - Journal of chemistry, 2019 - Wiley Online Library
The objective of this review is to survey the development of the optimization of lyophilization.
The optimization study of the lyophilizer has been roughly developing by the order of (i) trial …

Achieving continuous manufacturing in lyophilization: Technologies and approaches

R Pisano, A Arsiccio, LC Capozzi, BL Trout - European Journal of …, 2019 - Elsevier
This paper provides an organic overview of the most interesting continuous freeze-drying
concepts that have been proposed over the years. Attention has mainly been focused on the …

From batch to continuous: freeze-drying of suspended vials for pharmaceuticals in unit-doses

LC Capozzi, BL Trout, R Pisano - Industrial & Engineering …, 2019 - ACS Publications
In response to the current trend in the pharmaceutical industry, a new concept for the freeze-
drying of pharmaceuticals in unit-doses is presented: the continuous freeze …

3D mathematical modelling to understand atypical heat transfer observed in vial freeze-drying

B Scutellà, A Plana-Fattori, S Passot, E Bourlès… - Applied thermal …, 2017 - Elsevier
In pharmaceutical freeze-drying, the position of the product container (vial) on the shelf of
the equipment constitutes a major issue for the final product quality. Vials located at the shelf …

How vial geometry variability influences heat transfer and product temperature during freeze-drying

B Scutella, S Passot, E Bourlés, F Fonseca… - Journal of …, 2017 - Elsevier
Vial design features can play a significant role in heat transfer between the shelf and the
product and, consequently, in the final quality of the freeze-dried product. Our objective was …

[HTML][HTML] Stochastic shelf-scale modeling framework for the freezing stage in freeze-drying processes

LT Deck, DR Ochsenbein, M Mazzotti - International Journal of …, 2022 - Elsevier
Freezing and freeze-drying processes are commonly used to improve the stability and thus
shelf life of pharmaceutical formulations. Despite strict product quality requirements, batch …

Freeze-drying: A relevant unit operation in the manufacture of foods, nutritional products, and pharmaceuticals

G Assegehegn, E Brito-de la Fuente, JM Franco… - Advances in food and …, 2020 - Elsevier
Freeze-drying, a drying unit operation frequently used in food, pharmaceutical, and
biopharmaceutical industries to prolong the shelf life of labile products, is an energy …

Primary drying optimization in pharmaceutical freeze-drying: a multivial stochastic modeling framework

G Bano, R De-Luca, E Tomba, A Marcelli… - Industrial & …, 2020 - ACS Publications
Primary drying is the most time-consuming and energy-intensive step in pharmaceutical
freeze-drying. Minimizing the duration of this stage is of paramount importance to speed up …

Determining maximum sublimation rate for a production lyophilizer: computational modeling and comparison with ice slab tests

V Kshirsagar, S Tchessalov, F Kanka, D Hiebert… - Journal of …, 2019 - Elsevier
Equipment capability is an important factor in scale up and technology transfer for
lyophilized pharmaceutical products. Experimental determination of equipment capability …