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Variability in the a and ß anomer content of commercially available lactose

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journal contribution
posted on 2023-06-09, 15:54 authored by Mohamad Jamal Altamimi, Kim Wolff, Ali Nokhodchi, Gary P Martin, Paul G Royall
Lactose, 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 Pharmaceutics

ISSN

03785173

Publisher

Elsevier

Volume

555

Page range

237-249

Department affiliated with

  • Chemistry Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2018-11-14

First Open Access (FOA) Date

2019-11-02

First Compliant Deposit (FCD) Date

2018-11-13

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