Composition comprising her2 antibody, formulation and process of preparation thereof
AssigneeEnzene Biosciences Limited
InventorsHimanshu GADGIL, Varda KOLAPKAR, Nildip CHAUHAN, Abijar BHORI, Narahari Chittoor RAO
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Abstract
The present invention relates to pharmaceutical composition comprising HER2 antibody, its analogues or complexes. The present invention further relates to a liquid formulation comprising HER2 antibody, its analogues or complexes and processes for preparing the same and methods of using it. More particularly, the present invention relates to a liquid formulation comprising Pertuzumab, Trastuzumab, and process for preparing the formulations.
Claims14
A pharmaceutical composition comprising:
- a) a HER2 antibody selected from pertuzumab and trastuzumab, analogues or complexes thereof;
- b) a buffer;
- c) a stabilizer;
- and
- d) a surfactant,
- wherein the pH of the composition ranges from about 4.7 to about 6.5, preferably from about 4.9 to about 6.3.
A pharmaceutical composition comprising:
- a) a HER2 antibody selected from pertuzumab and trastuzumab;
- b) a buffer being succinic acid;
- c) a stabilizer being sucrose;
- and
- d) a surfactant being Polysorbate 20.
A pharmaceutical formulation comprising:
- a) a HER2 antibody selected from pertuzumab or trastuzumab, analogues or complexes thereof in an amount from about 10 mg/ml to about 100 mg/ml;
- b) a buffer in an amount from about 5 mM to about 30 mM;
- c) a stabilizer in an amount from 20 mg/ml to about 100 mg/ml;
- and
- d) a surfactant in an amount from 0.1 mg/ml to about 0.5 mg/ml.
A process for preparing HER2 antibody formulation for injection, said process comprising:
- a) dissolving a buffering agent, a stabilizer and a surfactant in water for injection to obtain a buffer solution;
- b) dissolving a HER2 antibody into the buffer formulation solution of step (a) to obtain a bulk solution;
- and
- c) adjusting pH of formulated bulk solution of step (b) with a pH-adjusting agent to a pH range from about 4.7 to about 6.5, preferably at 4.9 to 6.3.
Dependencies are inferred from the claim text.