Dry growth hormone composition transiently linked to a polymer carrier

摘要

The present invention relates to dry compositions of rhGH polymer prodrug containing a lyoprotectant and, optionally, one or more than one excipient. Such compositions are stable for at least 1 year, when stored at 2-8° C. The invention further relates to methods of manufacturing said compositions, containers comprising such composition as well as a kit of parts.

主权项

1. A dry composition comprising:
a therapeutically effective amount of a recombinant human growth hormone (“rhGH”) polymer prodrug and one or more lyoprotectants, wherein the rhGH is transiently linked via a reversible linker moiety to a polymer carrier; wherein the composition is stable for at least 6 months when stored at temperatures ranging from 2 to 25° C., and wherein during such storage less than 5% of the rhGH is released from the rhGH polymer prodrug as free rhGH.