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Related Experiment Videos

Recombinant human growth hormone poly(lactic-co-glycolic acid) microsphere formulation development.

Jones1, Putney, Johnson

  • 1Alkermes, Cambridge, MA 02139, USA

Advanced Drug Delivery Reviews
|June 6, 2000
PubMed
Summary
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Developing a sustained release formulation of recombinant human growth hormone (rhGH) using poly(lactic-co-glycolic acid) (PLGA) microspheres ensures protein integrity. A novel cryogenic process provides continuous, safe rhGH release, potentially improving efficacy and reducing dosage.

Area of Science:

  • Biotechnology
  • Polymer Science
  • Pharmacology

Background:

  • Sustained release formulations aim to improve therapeutic protein delivery.
  • Recombinant human growth hormone (rhGH) requires stable delivery systems for efficacy.
  • Poly(lactic-co-glycolic acid) (PLGA) is a key biodegradable polymer for drug delivery microspheres.

Purpose of the Study:

  • To develop and evaluate a sustained release formulation of rhGH using PLGA microspheres.
  • To ensure protein integrity during microencapsulation and release.
  • To establish in vivo-in vitro release correlations and assess in vivo efficacy.

Main Methods:

  • Microencapsulation of rhGH in PLGA using conventional and novel cryogenic processes.
  • In vitro and in vivo release kinetic studies in animal models (rhesus monkeys).

Related Experiment Videos

  • Assessment of protein integrity, biological activity, and immunogenicity.
  • Safety evaluation in growth hormone-deficient adults.

    • Main Results:

    • The cryogenic process achieved continuous release of biologically active, non-immunogenic rhGH.
    • Continuous rhGH administration in juvenile rhesus monkeys showed a greater IGF-I response than daily dosing.
    • The rhGH PLGA formulation was safe and well-tolerated in growth hormone-deficient adults.
    • Established correlation between in vitro and in vivo release profiles.

    Conclusions:

    • The novel cryogenic process is effective for producing stable, sustained-release rhGH PLGA formulations.
    • Continuous rhGH delivery may offer improved efficacy and reduced total dosage compared to daily administration.
    • This PLGA formulation and development strategy serve as a model for future therapeutic protein delivery systems.