3PC-026 Formulation and galenic characterisation of a tacrolimus adhesive gel for treatment of ulcerative proctitis

Abstract

closure integrity, impurities, charge variants, oxidation, endotoxin, particulates and biological activity. Results A total of 132 syringes underwent three freeze-thaw cycles, exposing each syringe for a total of 144 hours to 30°C and 144 hours to À5°C. Following exposure, 66 syringes were used for the analysis and 66 were retained. The effects of this thermal cycling on the critical quality attributes of SB5 from baseline is shown in table 1. Conclusion and relevance SB5 was stable in the immediate pack when exposed to multiple freeze-thaw cycles. These results may help hospital pharmacists assess the impact of temperature excursions during shipment or storage on product quality of SB5. REFERENCES AND/OR ACKNOWLEDGEMENTS Conflict of interest Corporate sponsored research or other substantive relationships: HE is an employee of, and holds stock in Biogen, responsible for the commercialisation of SB5. JK, JY, DP, SJH and SJP are employees of Samsung Bioepis, the marketing authorisation holder of SB5.