Continuous crystallization and its potential use in drug substance Manufacture: A review

•Comprehensive review on continuous drug product manufacturing.•Discussion on mixed suspension mixed product removal (MSMPR) crystallizers.•Discussion on processes parameters’ effects on critical quality attributes.•Strategies in continuous processes to control the critical quality attributes. Inter...

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Bibliographic Details
Published inJournal of crystal growth Vol. 601; p. 126958
Main Authors Eren, Ayse, Civati, Francesco, Ma, Wenchuan, Gamekkanda, Janaka C., Myerson, Allan S.
Format Journal Article
LanguageEnglish
Published Elsevier B.V 01.01.2023
Subjects
A1. Continuous crystallization
A1. Impurities
A1. Polymorphism
A1. Process design
A2. Industrial crystallization
B3. MSMPRs
A1. Process design
A1. Impurities
B3. MSMPRs
A1. Polymorphism
A1. Continuous crystallization
A2. Industrial crystallization
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Summary:•Comprehensive review on continuous drug product manufacturing.•Discussion on mixed suspension mixed product removal (MSMPR) crystallizers.•Discussion on processes parameters’ effects on critical quality attributes.•Strategies in continuous processes to control the critical quality attributes. Interest in the continuous manufacturing in the pharmaceutical industry for the production of Active Pharmaceutical Ingredients (API’s) has greatly increased in recent years. This has led to a variety of studies on continuous processing including a large number of studies in the area of continuous crystallization. While various potential crystallizer configurations exist, the vast majority of work in this area has focused around the Mixed Suspension Mixed Product Removal (MSMPR) crystallizer. In this review, MSMPR crystallizers will be described along with their use in continuous API manufacture.
ISSN:0022-0248
1873-5002
DOI:10.1016/j.jcrysgro.2022.126958