FORMULATIONS OF RECOMBINANT HUMAN BILE SALT-STIMULATED LIPASE

摘要

The present invention relates to improved formulations of recombinant human bile salt stimulated lipase (rhBSSL), including those 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 comprises rhBSSL, a crystalline bulking agent and an amorphous stabilizer that is a different chemical entity to said crystalline bulking agent. The formulations of the present invention have one or more desired properties, including those that relate to stability, decreased aggregation and/or formation of insoluble aggregates in solution. The lyophilized formulations of the present invention have pharmaceutical utility, particularly for the administration of rhBSSL to human infants.

主权项

1. A formulation suitable for lyophilization comprising:
(i) recombinant human bile salt-stimulated lipase (rhBSSL); (ii) a crystalline bulking agent; and (iii) an amorphous stabilizer that is a different chemical entity to said crystalline bulking agent and is present at a relative amount of between about 0.1 mg and about 0.5 mg per mg of said rhBSSL.