Improved pharmaceutical stability of a boronphenylalanine mannitol formulation for boron neutron capture therapy
Halbert, Gavin and Elliott, Moira and Ford, Steven and Dick, Lindsay and Schmidt, Elke (2013) Improved pharmaceutical stability of a boronphenylalanine mannitol formulation for boron neutron capture therapy. European Journal of Pharmaceutical Sciences, 48. pp. 735-739. ISSN 0928-0987 (https://doi.org/10.1016/j.ejps.2013.01.008)
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Boron neutron capture therapy (BNCT) is a radiotherapy based cancer treatment requiring the availability of a low energy thermal neutron beam and a boron containing drug.These requirements limit BNCT availability with the latter pharmaceutical issue related to the extremely short shelf-life and clinical acceptability of the current fructose based L-boronpheylalanine (BPA) formulation.Resolution of the formulation issues would remove this factor and therefore the stability of an alternative mannitol BPA formulation has been investigated. A mannitol BPA solution formulation was prepared and either lyophilised or stored as a solution at varying temperatures. After suitable periods the formulation was analysed by HPLC for BPA and degradation products. Lyophilised and solution mannitol BPA formulations exhibited a temperature and time dependent loss of BPA with concomitant increases in degradation products. Autoclaving the solution induced and accelerated degradation. A solution or lyophilised mannitol BPA formulation has a shelf-life of between one and four years respectively, a marked improvement over the current fructose formulation.Due to temperature dependent degradation the formulation cannot be terminally sterilised by autoclaving.The enhanced stability of the mannitol formulation removes the requirement for extemporaneous aseptic preparation of BPA just prior to treatment and eliminates one of the issues complicating the delivery of BNCT.
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Item type: Article ID code: 42788 Dates: DateEvent2013Published23 January 2013Published OnlineSubjects: Medicine > Pharmacy and materia medica Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
Technology and Innovation Centre > Continuous Manufacturing and Crystallisation (CMAC)Depositing user: Pure Administrator Date deposited: 08 Feb 2013 14:45 Last modified: 08 Apr 2024 20:20 Related URLs: URI: https://strathprints.strath.ac.uk/id/eprint/42788