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US 5,334,382 AGranted
Lyophilized polyethylene oxide modified catalase composition, polypeptide complexes with cyclodextrin and treatment of diseases with the catalase compositions
AssigneeSterling Winthrop Inc.
InventorsChristopher P. Phillips, Robert A. Snow
Life of this patent
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Abstract
Disclosed are lyophilized biologically active proteinaceous compositions containing low diol polyalkylene oxide, such as polyethylene glycol, covalently attached to a biologically active proteinaceous substance and combined with the cryoprotectant cyclodextrin.
Claims28
A reconstituted lyophilized formulation of polyethylene glycol and a biologically active catalase conjugate comprising:
- a) polyethylene glycol having a molecular weight of from about 1,000 to about 15,000 daltons and consisting of less than about 10% w/w non-monomethoxylated polyethylene glycol and more than 90% w/w monomethoxylated polyethylene glycol;
- said conjugate having an enzymatic activity of from about 150 to about 150,000 U/ml;
- b) from about 0.1 to about 20% w/v of cyclodextrin;
- and
- c) from about 0.01 to about 50 nM buffer, said formulation having a pH of from about 5.7 to about 6.5.
2 more elements
A process of preparing a lyophilized biologically active catalase composition comprising the steps of:
- a) carboxylating polyethylene glycol containing less than 10% w/w non-monomethoxylated polyethylene glycol;
- b) activating said carboxylated polyethylene glycol to obtain an active polyethylene glycol ester;
- c) covalently attaching said active polyethylene glycol ester to a biologically active catalase;
- d) solubilizing said covalently attached polyethylene glycol ester and said biologically active catalase in an aqueous media;
- e) solubilizing cyclodextrin in said aqueous media to obtain a homogeneous solution;
- f) buffering said solution to a pH of from about 5.7 to about 6.5;
- and
- h) lyophilizing the solution.
5 more elements
Dependencies are inferred from the claim text.