A Review of Pharmaceutical Extrusion: Critical Process Parameters and Scaling-up

[en] Hot melt extrusion has been a widely used process in the pharmaceutical area for three decades. In this field, it is important to optimize the formulation in order to meet specific requirements. However, the process parameters of the extruder should be as much investigated as the formulation since they have a major impact on the final product characteristics. Moreover, a design space should be defined in order to obtain the expected product within the defined limits. This gives some freedom to operate as long as the processing parameters stay within the limits of the design space. Those limits can be investigated by varying randomly the process parameters but it is recommended to use design of experiments. An examination of the literature is reported in this review to summarize the impact of the variation of the process parameters on the final product properties. Indeed, the homogeneity of the mixing, the state of the drug (crystalline or amorphous), the dissolution rate, the residence time, can be influenced by variations in the process parameters. In particular, the impact of the following process parameters: temperature, screw design, screw speed and feeding, on the final product, has been reviewed.

Research Center/Unit :

Centre Interfacultaire de Recherche du Médicament - CIRM

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Thiry, Justine ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique

Krier, Fabrice ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique

Evrard, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique

Language :

English

Title :

A Review of Pharmaceutical Extrusion: Critical Process Parameters and Scaling-up

Publication date :

01 February 2015

Journal title :

International Journal of Pharmaceutics

ISSN :

0378-5173

eISSN :

1873-3476

Publisher :

Elsevier Science, Amsterdam, Netherlands

Volume :

479

Issue :

Pages :

227-240

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

http://www.sciencedirect.com/science/article/pii/S0378517314009338

Name of the research project :

MYCOMELT

Available on ORBi :

since 05 January 2015

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Scopus citations^®

130

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118

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