Protein-containing aqueous liquid formulation
AssigneeJCR Pharmaceuticals Co., Ltd.
InventorsHidehito Yasukawa, Takashi Hanada, Junya Tani, Shinji Okabe, Yuuka Asano
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Abstract
An aqueous preparation containing a protein as an active ingredient which is stable in storage in solution and makes an injection pain reduced is provided. More specifically an aqueous preparation containing a phosphate buffer at a concentration of 1 to 20 mM and a protein as an active ingredient is provided. Further more specifically provided is an aqueous preparation containing a phosphate buffer at a concentration of 1 to 20 mM, human growth hormone as an active ingredient, a poloxamer as a non-ionic surfactant; and phenol as a isotonic agent.
Claims4
An aqueous preparation, comprising
- 8 to 12 mM of a phosphate buffer;
- 4 to 8 mg/mL of growth hormone;
- 2 mg/mL of poloxamer 188;
- 3.3 mg/mL of phenol;
- and D-mannitol,
- wherein the aqueous preparation has a pH of 6.2, an osmotic pressure ratio of 0.9 to 1.1, and does not include NaCl.
An aqueous preparation, consisting of 10 mM of a phosphate buffer;
- 4 or 8 mg/mL of growth hormone;
- 2 mg/mL of poloxamer 188;
- 3.3 mg/mL of phenol;
- and 40 mg/mL of D-mannitol,
- wherein the aqueous preparation has a pH of 6.2 and an osmotic pressure ratio of 0.9 to 1.1.
Dependencies are inferred from the claim text.