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Insulin glargine is a synthetic long-acting insulin product used for patients with diabetes mellitus. In this study, to obtain the further desirable blood-glucose lowering profile of insulin glargine, we investigated the effects of   β  -cyclodextrin sulfate (Sul-  β  -CyD) and sulfobutylether   β  -cyclodextrin (SBE7-  β  -CyD) on physicochemical properties of insulin glargine and pharmacokinetics/pharmacodynamics of insulin glargine after subcutaneous injection to rats. Sul-  β  -CyD and SBE7-  β  -CyD increased solubility of insulin glargine. SBE7-  β  -CyD suppressed the formation of oligomer and enhanced the dissolution rate of insulin glargine from its precipitate, compared to that of Sul-  β  -CyD. Additionally, we revealed that after subcutaneous administration of an insulin glargine solution, SBE7-  β  -CyD, but not Sul-  β  -CyD, increased bioavailability and sustained the blood-glucose lowering effect, possibly due to the inhibitory effects of SBE7-  β  -CyD on the enzymatic degradation at the injection site. These results suggest that SBE7-  β  -CyD could be a useful excipient for sustained release of insulin glargine.

Effects of Selected Anionic β-Cyclodextrins on Persistence of Blood Glucose Lowering by Insulin Glargine after Subcutaneous Injection to Rats