PMID- 20690791 OWN - NLM STAT- MEDLINE DCOM- 20101129 LR - 20181201 IS - 1464-5246 (Electronic) IS - 0265-2048 (Linking) VI - 27 IP - 6 DP - 2010 TI - Controlled release of bioactive recombinant human growth hormone from PLGA microparticles. PG - 552-60 LID - 10.3109/02652048.2010.489974 [doi] AB - 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. FAU - Rafi, M AU - Rafi M AD - Product Development Cell, National Institute of Immunology, Aruna Asaf Ali Marg, New Delhi 110067, India. FAU - Singh, Surinder M AU - Singh SM FAU - Kanchan, Vibhu AU - Kanchan V FAU - Anish, C K AU - Anish CK FAU - Panda, Amulya K AU - Panda AK LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - J Microencapsul JT - Journal of microencapsulation JID - 8500513 RN - 0 (Delayed-Action Preparations) RN - 0 (Recombinant Proteins) RN - 12629-01-5 (Human Growth Hormone) RN - 1SIA8062RS (Polylactic Acid-Polyglycolic Acid Copolymer) RN - 26009-03-0 (Polyglycolic Acid) RN - 33X04XA5AT (Lactic Acid) SB - IM MH - Animals MH - Cell Line, Tumor MH - Cell Proliferation/drug effects MH - Delayed-Action Preparations/*chemistry MH - Drug Compounding MH - Freeze Drying MH - Human Growth Hormone/*administration & dosage/blood/chemistry/*pharmacology MH - Humans MH - Lactic Acid/*chemistry MH - Polyglycolic Acid/*chemistry MH - Polylactic Acid-Polyglycolic Acid Copolymer MH - Protein Denaturation MH - Protein Stability MH - Rats MH - Rats, Wistar MH - Recombinant Proteins/administration & dosage/blood/chemistry/pharmacology EDAT- 2010/08/10 06:00 MHDA- 2010/12/14 06:00 CRDT- 2010/08/10 06:00 PHST- 2010/08/10 06:00 [entrez] PHST- 2010/08/10 06:00 [pubmed] PHST- 2010/12/14 06:00 [medline] AID - 10.3109/02652048.2010.489974 [doi] PST - ppublish SO - J Microencapsul. 2010;27(6):552-60. doi: 10.3109/02652048.2010.489974.