Lipid Vesicle Composition
It is an object of the present invention to provide an enzyme preparation which is excellent in stability in blood (blood residence) and in transfer to a target organ (targeting property), and can be used effectively in enzyme replacement therapy or the like. This problem is solved by a lipid vesicle composition wherein vesicles composed of a lipid bilayer membrane are encapsulating an enzyme, the composition being capable of retaining stably the activity of the enzyme even outside the stable pH range of the enzyme.
1 . A lipid vesicle composition wherein vesicles composed of a lipid bilayer membrane are encapsulating an enzyme, wherein described composition is capable of retaining stably the activity of said enzyme even outside the stable pH range of said enzyme.
2 . The composition according to claim 1 , which is capable of functioning as an enzyme carrier that delivers the enzyme to a target organ in the living body through blood flow.
3 . The composition according to claim 1 or 2 , wherein said lipid bilayer membrane contains an anionic lipid.
4 . The composition according to claim 3 , wherein said anionic lipid is 1,5-O-dihexadecyl-N-succinyl-L-glutamate.
5 . The composition according to claim 1 , wherein said enzyme is glucocerebrosidase.
6 . A therapeutic agent for Gaucher disease, comprising the composition according to claim 5 .
7 . A method for stabilizing an enzyme, comprising encapsulating the enzyme in vesicles composed of a lipid bilayer membrane in the presence of a pH buffer and/or a surfactant.
8 . The method according to claim 7 , wherein said enzyme is glucocerebrosidase.
9 . A method for preparing a lipid vesicle composition, comprising encapsulating an enzyme in vesicles composed of a lipid bilayer membrane in the presence of a pH buffer and/or a surfactant.
10 . The method according to claim 9 , wherein the pH buffer and/or the surfactant is present in both the internal aqueous phase and the external aqueous phase of said vesicles.
11 . The method according to claim 9 or 10 , wherein said enzyme is glucocerebrosidase.
12 . A method for treating Gaucher disease, comprising administration of the composition according to claim 5 to a Gaucher disease patient.