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Related Experiment Videos

Improving protein therapeutics with sustained-release formulations

S D Putney1, P A Burke

  • 1Alkermes, Inc., Cambridge, MA 02139, USA. sputney@alkermes.com

Nature Biotechnology
|March 6, 1998
PubMed
Summary
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Injectable microsphere formulations offer a solution for protein therapeutics, overcoming challenges like short half-lives and instability. This advanced delivery system enables less frequent dosing and broader therapeutic applications.

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Protein therapeutics face limitations including short in vivo half-lives, instability, and poor oral bioavailability, necessitating frequent injections.
  • Current delivery systems for protein drugs have not advanced sufficiently to meet the needs of this expanding therapeutic class.

Purpose of the Study:

  • To explore the potential of injectable depot formulations using biodegradable polymers for sustained protein drug delivery.
  • To address the challenges of protein instability within microsphere dosage forms.

Main Methods:

  • Encapsulation of therapeutic proteins within microspheres made of biodegradable polymers.
  • Development and application of advanced protein stabilization techniques.

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Main Results:

  • Advances in protein stabilization have enabled the development of sustained-release formulations for several therapeutic proteins.
  • Clinical trials for a monthly formulation of human growth hormone are currently underway.

Conclusions:

  • Biodegradable polymer microspheres represent a promising strategy for developing sustained-release protein therapeutics.
  • Improved protein stabilization is key to the clinical success of these advanced drug delivery systems, potentially enabling new therapeutic applications.