Armstrong, Nicholas J.,Bowen, Mayumi N.,Maa, Yuh-Fun
申请号：
NZ73786213
公开号：
NZ737862A
申请日:
2013.05.17
申请国别(地区):
NZ
年份:
2020
代理人:
摘要：
The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 100 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscosity of the suspension vehicle is less than about 20 centipoise at about 25˚C, and wherein the non-aqueous suspension vehicle comprises a mixture of propylene glycol dicarpylate and ethyl lactate at a ratio of less than 1, and wherein the peak frequency of particle size distribution of the suspension formulation is less than 13µm. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.
