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Quality and stability of extemporaneous pyridoxal phosphate preparations used in the treatment of paediatric epilepsy

Mohamed-Ahmed, AHA; Wilson, MP; Albuera, M; Chen, T; Mills, PB; Footitt, PB; Clayton, PT; (2017) Quality and stability of extemporaneous pyridoxal phosphate preparations used in the treatment of paediatric epilepsy. Journal of Pharmacy and Pharmacology , 69 (4) pp. 480-488. 10.1111/jphp.12701. Green open access

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Abstract

Objectives To assess pyridoxal 5’-phosphate (PLP) content and stability of extemporaneous PLP liquids prepared from dietary supplements used for the treatment of vitamin B6-dependent epilepsy. Methods PLP liquids were prepared in accordance with guidelines given to patients from marketed 50 mg PLP dietary capsules and tablets. The PLP content and stability was evaluated under conditions resembling the clinic setting using reverse phase HPLC and mass spectrometry. Key findings PLP content in most of the extemporaneously prepared liquids from dietary supplements was found to be different to the expected amount (~16-60 mg). Most of these PLP extemporaneous liquids were stable at room temperature (protected from light) after 24 h but unstable after 4 h when exposed to light. A key photo-degradation product of PLP in water was confirmed as 4-pyridoxic acid 5'-phosphate (PAP). Conclusion PLP tablets from Solgar® were found to be the most reliable product for the preparation of extemporaneous PLP liquids. This work highlighted the difference between the marketed PLP dietary supplements quality and the importance of proper storage of aqueous PLP. There is a need to develop pharmaceutical forms of PLP that ensure dose accuracy and avoid potentially unsafe impurities with the aim of enhancing safety and compliance.

Type: Article
Title: Quality and stability of extemporaneous pyridoxal phosphate preparations used in the treatment of paediatric epilepsy
Open access status: An open access version is available from UCL Discovery
DOI: 10.1111/jphp.12701
Publisher version: http://doi.org/10.1111/jphp.12701
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Dietary supplements; epilepsy; pyridox(am)ine 5′-phosphate oxidase deficiency; pyridoxal-5-phosphate; stability
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Genetics and Genomic Medicine Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1536382
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