Aflibercept ophthalmic pharmaceutical composition
AssigneeSam Chun Dang Pharm. Co., Ltd.
InventorsGuang-Jin Im, Byung-Jhip Ha, Na-Won Park, Yong-Seop Park
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Abstract
Provided is an ophthalmic pharmaceutical composition having a certain pH, comprising aflibercept as an active ingredient and an acetate salt buffering agent, wherein the composition is free of an ionic tonicity agent, remarkably reduces the formation of dimeric and multimeric impurities, and maintains the biological activity in a high level for a long time, under the accelerated and stress conditions as well as under the cold storage condition.
Claims12
An ophthalmic pharmaceutical composition having a pH ranging from pH 5.2 to 5.7, comprising (a) a therapeutically effective amount of aflibercept;
- (b) 10 to 20 mM of a sodium acetate buffering agent;
- (c) 6 to 8 w/v % of a sugar or 3 to 7 w/v % of a sugar alcohol;
- and (d) 0.01 to 0.1 w/v % of a surfactant in an aqueous medium, wherein the ophthalmic pharmaceutical composition is free of an ionic tonicity agent.
An ophthalmic pharmaceutical composition having a pH of about 5.5, consisting of 40 mg/ml of aflibercept;
- 10 to 15 mM of a sodium acetate buffering agent;
- 7 w/v % of sucrose;
- 0.03 w/v % of polyoxyethylene (20) sorbitan monolaurate, and an aqueous medium.
An ophthalmic pharmaceutical composition having a pH of about 5.5, consisting of 40 mg/ml of aflibercept;
- 10 to 15 mM of a sodium acetate buffering agent;
- 8 w/v % of trehalose;
- 0.03 w/v % of polyoxyethylene (20) sorbitan monolaurate, and an aqueous medium.
Dependencies are inferred from the claim text.