Human growth hormone-containing aqueous pharmaceutical composition
AssigneeJCR Pharmaceuticals Co., Ltd.
InventorsMasafumi Tatsumi, Katsura Inoue, Junichi Kajihara
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Abstract
Provided is an aqueous pharmaceutical composition comprising human growth hormone wherein said human growth hormone is dissolved in a benzalkonium chloride-containing, slightly to weakly acidic solution buffered, most preferably, with maleate. The composition is sufficiently stable to be supplied in liquid state and can be prepared as a less painful composition.
Claims38
An aqueous pharmaceutical composition for injection comprising human growth hormone dissolved in a solution comprising benzalkonium chloride and a buffering agent selected from maleate, succinate or citrate, said solution further comprising at least one of D-mannitol and sodium chloride, the aqueous composition having a pH which is slightly to weakly acidic.
An aqueous pharmaceutical composition for injection comprising human growth hormone dissolved in a solution comprising benzalkonium chloride in an amount from 0.002 to 0.03 mg per ml of said composition and a buffering agent in an amount from 1 to 100 mM and selected from maleate, succinate or citrate, wherein the pH of the composition is equal to or greater than 5 and less than 7 and the composition is less painful when injected, the solution further comprising D-mannitol, neutral salt or mixture thereof.
Dependencies are inferred from the claim text.