Aqueous Pharmaceutical composition containing a Therapeutic Agent and organic guanidine and guanidine derivative or a composition that includes an injection
Aqueous Pharmaceutical composition, particularly an aqueous ophthalmic composition, particularly suitable as an injection, intravitreal injection.The composition includes a Biological Therapeutic Agent (e.g., an isolated monoclonal antibody that specifically binds to a Protein, C5) tends to increase the viscosity of the composition and / or guanidine and guanidine derivative (e.g., L - arginine) tends to decrease. Viscosity of the composition.Claim 1: an aqueous composition suitable for injection, which comprises: a Therapeutic Agent where the Biological Therapeutic Agent when used to form a solution with a concentration of 100 mm.The biological Therapeutic Agent in water, resulting in the solution has a viscosity that is at least 10 CP； and / or guanidine guanidine Derivative, the guanidine derivative has the formula (1): r u00b9 is Zero, ch u2083, c u2099h u2082 u2099 u208a u2081, c u2099h u2082 u2099,Or c u2099h u2082 u2099 u208b u2081 (n = 1 - 10)； and / or R u00b2 is zero or any chemical not significantly reduces the ability of the guanidine Group to decrease the viscosity of the composition； and r u00b9 R u00b2 are never zero and at the same time； and / or guanidine and guanidine derivative is present in The composition in a concentration of at least 25 mm. But not more than 100 mm.And Water； the composition has a viscosity that is not greater than 10 hundredths of Poise. 8: claim membership in any of the preceding claims where the Agent is a Biological Therapeutic Antibody Isotype lgg1 / L.Composición farmacéutica acuosa, particularmente una composición oftálmica acuosa, adecuada como una inyección, particularmente una inyección intravítrea. La composición incluye un agente terapéutico biológico (por ejemplo, un anticuerpo monoclonal aislado que específicamente se une a una proteína C5) que tiende a elevar la viscosidad de la composición y una guanidina y/o derivado de guanidina (por ej., L-arginina) que tiende a disminuir la viscosidad de la composición
