title: Controlled release of bioactive recombinant human growth hormone from PLGA microparticles.
abstract: Controlled release formulation of recombinant human growth hormone (r-hGH) was achieved using poly lactide-co-glycolide (PLGA) polymer. Denaturation of r-hGH by dichloromethane during primary emulsification step of particle preparation was minimized by using human serum albumin whereas inclusion of sucrose and sodium bicarbonate helped in reducing protein denaturation during lyophilization and polymer particle degradation. Encapsulation efficiency of r-hGH entrapped in PLGA particles (size approximately 30 microm) was around 45% with protein load 20 microg of r-hGH/mg of polymer particles. Porous particles showed quick release of r-hGH in comparison to non-porous particles in vitro. More than 10 ng/mL of bioactive r-hGH was found in the serum of the experimental animals observed for a 30-day period after a single intramuscular injection of the polymeric formulation. Incorporation of optimal stabilizers is thus essential for the development of a stable, month long controlled release of polymer particle based r-hGH formulation.
authors.affiliation: Product Development Cell, National Institute of Immunology, Aruna Asaf Ali Marg, New Delhi 110067, India.
authors.forename: M
authors.initials: M
authors.lastname: Rafi
authors.forename: Surinder M
authors.initials: SM
authors.lastname: Singh
authors.forename: Vibhu
authors.initials: V
authors.lastname: Kanchan
authors.forename: C K
authors.initials: CK
authors.lastname: Anish
authors.forename: Amulya K
authors.initials: AK
authors.lastname: Panda
mesh_terms: D000818:Animals; D045744:Cell Line, Tumor; D049109:Cell Proliferation / Q000187:drug effects; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004339:Drug Compounding; D005612:Freeze Drying; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000097:blood / Q000737:chemistry / Q000494:pharmacology*; D006801:Humans; D019344:Lactic Acid / Q000737:chemistry*; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011489:Protein Denaturation; D055550:Protein Stability; D051381:Rats; D017208:Rats, Wistar; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry / Q000494:pharmacology
chemical_list: D003692:Delayed-Action Preparations; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid