abstract |
The present invention relates to improved formulations of recombinant human bile salt stimulated lipase (rhBSSL), including those that are suitable for forming a lyophilized formulation of rhBSSL, lyophilized formulations of rhBSSL per se, unit dose forms of rhBSSL and reconstituted formulations of rhBSSL. The formulations of the present invention comprise rhBSSL, a crystalline volumetric agent and an amorphous stabilizer that is a chemical entity other than the crystalline volumetric agent. The formulations of the present invention have one or more desired properties, including those related to stability, decreased aggregation and / or formation of insoluble aggregates in solution. The lyophilized formulations of the present invention have pharmaceutical utility, in particular for the administration of rhBSSL to human infants. |