• search hit 7 of 11
Back to Result List

Process analytical techniques for hot-melt extrusion and their application to amorphous solid dispersions

  • Newly developed active pharmaceutical ingredients (APIs) are often poorly soluble in water. As a result the bioavailability of the API in the human body is reduced. One approach to overcome this restriction is the formulation of amorphous solid dispersions (ASDs), e.g., by hot-melt extrusion (HME). Thus, the poorly soluble crystalline form of the API is transferred into a more soluble amorphous form. To reach this aim in HME, the APIs are embedded in a polymer matrix. The resulting amorphous solid dispersions may contain small amounts of residual crystallinity and have the tendency to recrystallize. For the controlled release of the API in the final drug product the amount of crystallinity has to be known. This review assesses the available analytical methods that have been recently used for the characterization of ASDs and the quantification of crystalline API content. Well established techniques like near- and mid-infrared spectroscopy (NIR and MIR, respectively), Raman spectroscopy, and emerging ones like UV/VIS, terahertz, and ultrasonic spectroscopy are considered in detail. Furthermore, their advantages and limitations are discussed with regard to general practical applicability as process analytical technology (PAT) tools in industrial manufacturing. The review focuses on spectroscopic methods which have been proven as most suitable for in-line and on-line process analytics. Further aspects are spectroscopic techniques that have been or could be integrated into an extruder.

Download full text files

  • 1388.pdf
    eng

Export metadata

Additional Services

Share in Twitter Search Google Scholar
Metadaten
Name:Hitzer, Patrick; Bäuerle, Tim; Drieschner, Tobias; Ostertag, Edwin; Lorenz, Günter; Rebner, Karsten
DOI:https://doi.org/10.1007/s00216-017-0292-z
ISSN:1618-2642
eISSN:1618-2650
Erschienen in:Analytical and bioanalytical chemistry
Publisher:Springer
Place of publication:Berlin, Heidelberg
Document Type:Article
Language:English
Year of Publication:2017
Tag:UV/VIS spectroscopy; amorphous solid dispersions; hot-melt extrusion; pharmaceutical manufacturing; process analytical technology; vibrational spectroscopy
Volume:409
Issue:18
Pagenumber:13
First Page:4321
Last Page:4333
Dewey Decimal Classification:543 Analytische Chemie
Open Access:Nein
Licence (German):License Logo  Lizenzbedingungen Springer