IJP_lactose_ acceptted version.pdf (2.3 MB)
Variability in the a and ß anomer content of commercially available lactose
journal contribution
posted on 2023-06-09, 15:54 authored by Mohamad Jamal Altamimi, Kim Wolff, Ali Nokhodchi, Gary P Martin, Paul G RoyallLactose, a disaccharide is a ubiquitous excipient in many pharmaceutical formulations which exists in two anomeric forms; either as - or -lactose. The anomers have different properties which can affect their application. Nevertheless, batches of lactose products are widely produced by many manufacturers, and is available in many grades. However, the anomeric content of these batches has not been accurately characterized and reported previously. Therefore, the aim of this study was to analyse a set of 19 commercially available samples of lactose using a novel H?1-NMR technique to establish a library showing the anomeric content of a large range of lactose products. The lactose samples were also analysed by DSC. The anomeric content of the -lactose monohydrate samples were found to vary by more than 10%, which might in_uence bioavailability from ^nal formulations. The data showed that there is a need to determine and monitor the anomeric content of lactose and this should be a priority to both manufacturers and formulators of medicines.
History
Publication status
- Published
File Version
- Accepted version
Journal
International Journal of PharmaceuticsISSN
03785173Publisher
ElsevierExternal DOI
Volume
555Page range
237-249Department affiliated with
- Chemistry Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2018-11-14First Open Access (FOA) Date
2019-11-02First Compliant Deposit (FCD) Date
2018-11-13Usage metrics
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