Patent ID: 9657087
Date: 2017-05-23
CPC Classifications: A61K,A61P,C07K

Claim:
1. A pharmaceutical composition free of infective viral particles for subcutaneous injection in an anatomic site selected from the group consisting of arm, abdomen, and front of the thigh, comprising: a pool of anti-hepatitis B immunoglobulins prepared from a population of human donors; and an effective amount of an excipient that ensures the pool of anti-hepatitis B immunoglobulins retains chemical stability and biological activity upon storage, wherein: the pharmaceutical composition is in the form of a lyophilized powder; the excipient is selected from the group consisting of maltose, sucrose, D-sorbitol, glycine, PEG, and albumin; the pool of anti-hepatitis B immunoglobulins is at a dose that is higher than 2170 IU and is at least 2-fold higher than a dose of anti-hepatitis B immunoglobulins for administration by intramuscular injection; at least 90% of the proteins in the composition are human immunoglobulin G; when redissolved as a liquid composition, the liquid composition has a volume of equal or less than about 4.5 ml; and the dose of anti-hepatitis B immunoglobulins formulated for subcutaneous injection in an anatomic site selected from the group consisting of arm, abdomen, and front of the thigh is suitable for rapidly achieving a circulation level higher than 100 mIU/ml.