title: A month-long effect from a single injection of microencapsulated human growth hormone.
abstract: An injectable sustained-release form of human growth hormone (hGH) was developed by stabilizing and encapsulating the protein, without altering its integrity, into biodegradable microspheres using a novel cryogenic process. A single injection of microspheres in monkeys resulted in elevated serum levels of recombinant hGH (rhGH) for more than one month. Insulin-like growth factor-I (IGF-I) and its binding protein IGFBP-3, both of which are induced by hGH, were also elevated for four weeks by the rhGH containing microspheres to a level greater than that induced by the same amount of rhGH administered by daily injections. These results show that, by using appropriate methods of stabilization and encapsulation, the advantages of sustained-release formulations previously demonstrated for low-molecular-weight drugs can now be extended to protein therapeutics.
authors.affiliation: Alkermes, Inc., Cambridge, Massachusetts 02139, USA.
authors.forename: O L
authors.initials: OL
authors.lastname: Johnson
authors.forename: J L
authors.initials: JL
authors.lastname: Cleland
authors.forename: H J
authors.initials: HJ
authors.lastname: Lee
authors.forename: M
authors.initials: M
authors.lastname: Charnis
authors.forename: E
authors.initials: E
authors.lastname: Duenas
authors.forename: W
authors.initials: W
authors.lastname: Jaworowicz
authors.forename: D
authors.initials: D
authors.lastname: Shepard
authors.forename: A
authors.initials: A
authors.lastname: Shahzamani
authors.forename: A J
authors.initials: AJ
authors.lastname: Jones
authors.forename: S D
authors.initials: SD
authors.lastname: Putney
mesh_terms: D000818:Animals; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D013006:Growth Hormone / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006801:Humans; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008253:Macaca mulatta; D008297:Male; D008863:Microspheres; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use
chemical_list: D003692:Delayed-Action Preparations; D004337:Drug Carriers; D018972:Insulin-Like Growth Factor Binding Protein 3; D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone