Lyophilized sovateltide-based injectable formulation and a process for preparation

Abstract

A lyophilized Sovateltide-based injectable formulation, comprising sovateltide in the range from about 0.01 to about 0.02% w/w, trisodium citrate dihydrate is present in the range of from about 20 to about 80% w/w and mannitol is present in the range of from about 20 to about 80% w/w. A reconstituted liquid composition comprising sovateltide; trisodium citrate; mannitol and water or 0.9% aqueous sodium chloride solution and process for the preparation of a lyophilized pharmaceutical composition of sovateltide comprising: dissolving sovateltide, trisodium citrate dihydrate and mannitol in water for injection; filter the solution through 0.2μ membrane filter; fill the individual vials up to the target fill volume; and lyophilization of the filled vials.

Dependencies are inferred from the claim text.