CONTINUOUS SUBCUTANEOUS INSULIN INFUSION METHODS WITH HYALURONAN DEGRADING ENZYME

摘要

PROBLEM TO BE SOLVED: To provide a composition, which is a stable formulation of a hyaluronan-degrading enzyme or a stable co-formulation of a fast-acting insulin and a hyaluronan degrading enzyme, including a recombinant human PH20 (rHuPH20).;SOLUTION: According to the present invention, there is provided a stable co-formulation composition. Here, the composition has a pH of 6.8 to 7.8 (including both end values) comprises: (a) a therapeutically effective amount of a fast-acting insulin; (b) a hyaluronan-degrading enzyme in an amount sufficient to render the composition super-fast acting; (c) NaCl at a concentration between or about between 50 mM to 120 mM (including both end values); (d) one or more stabilizing agents; and (e) one or more phenol preservatives. Here, the total amount of the one or more preservatives is 0.1 to 0.4% (including both end values) in terms of weight concentration (w/v%) of a pharmaceutical agent to allow the composition to be stable for at least 6 months at a temperature of 2 to 8°C (including both end values) and/or for at least 14 days at a temperature from of 20°C to 30°C(including both end values).;SELECTED DRAWING: None;COPYRIGHT: (C)2018,JPO&INPIT