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US 2003/0148938 A1Published application
Aqueous sustained-release formulations of proteins
AssigneeOrtho-McNeil Pharmaceutical, Inc.
InventorsBasant Sharma, Renzhe Jin, Sunitha Rudolph, Wing K. Cheung, Selima Begum, Marian Kelley
Life of this patent
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Abstract
The present invention is directed to sustained-release pharmaceutical formulations of therapeutic proteins containing carboxymethyl ether cellulose polymer and methods of manufacture and use thereof.
Claims19
A pharmaceutical formulation comprising:
- a) a pharmaceutically active amount of erythropoietin;
- b) a pharmaceutically acceptable pH buffering agent to provide a pH in a range of about pH 6 to about pH 9;
- c) a tonicity agent in a concentration range of about 0 to about 200 millimolar;
- and
- d) sodium carboxymethyl ether cellulose in a concentration range of about 0.5% to about 7% total formula weight, said CMC having a molecular weight in a range of about 50,000 daltons to about 1,000,000 daltons.
2 more elements
A method of formulation comprising the steps, in any order:
- a) providing a pH buffered erythropoietin sample;
- b) admixing a quantity of CMC to the pH buffered erythropoietin sample sufficient to provide a final concentration of about 0.5% to about 7% CMC total formula weight;
- c) admixing a quantity of NaCl to the pH buffered erythropoietin sample sufficient to provide a final concentration of about 0 mM to about 170 mM NaCl;
- and
- d) adjusting the pH buffered erythropoietin sample with water sufficient to provide a predetermined final formulation volume and erythropoietin potency.
2 more elements
A pharmaceutical formulation comprising:
- a) a pharmaceutically active amount of a protein;
- b) a pharmaceutically acceptable pH buffering agent to provide a pH in the range of about pH 4.5 to about pH 9;
- c) a tonicity agent in the concentration range of about 0 to about 200 millimolar;
- and
- d) Sodium carboxymethyl ether cellulose in the concentration range of about 0.5% to about 7% total formula weight, said CMC having a molecular weight in the range of about 50,000 daltons to about 1,000,000 daltons.
2 more elements
Dependencies are inferred from the claim text.