Background Enzyme replacement therapy with SUCRAID offers a pharmacologic alternative to sucrose free diets to treat symptoms in congenital sucrase–isomaltase deficiency (CSID). But a resent shortage leaves patients without any treatment. Invertase, like Kerry’s BIOINVERT 200 solution, is an enzyme widely used in confectionery production (E1103). It also hydrolyses sucrose to give glucose and fructose. It may be an interesting substitute for SUCRAID. However, this food grade solution needs pharmaceutical qualification.
Purpose To propose a method of pharmaceutical qualification of BIOINVERT 200 based on our experience, and to evaluate its specifications as a substitute for SUCRAID.
Material and methods Several characteristics were tested or measured, such as density (calculated by weighing), pH, osmolality (measurement by freezing point), enzyme activity (dosage with Sigma-Aldrich MAK118 set), residual solvent (search by gas chromatography coupled with flame ionisation detector), sterility test (by liquid cultures) and abnormal toxicity (tested on mice according to the European Pharmacopoeia).
Results The results obtained are shown in the table.
Conclusion Because of high osmolality, BIOINVERT, like SUCRAID, has to be diluted 10 times before use. The enzyme activity is lower than Kerry’s specifications (11 020–13 340 IU/mL at 55°C). It is also lower than SUCRAID (8500 IU/mL). For pharmaceutical qualification, heavy metals research is required. Then, the clinical effectiveness of BIOINVERT 200 could be tested.
References and/or acknowledgements The association ‘La vie sans sucre’ and Dr Mélanie Bonnet for her time and the loan of the microplate reader.
No conflict of interest
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