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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Accelerated in vitro release testing method for a long-acting peptide-PLGA formulation.

Meenakshi Goel1, Dennis Leung1, Amin Famili1

  • 1Small Molecule Pharmaceutical Sciences (SMPS), Genentech Inc., S. San Francisco, CA 94080, USA.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|May 16, 2021
PubMed
Summary

Developing an accelerated in vitro release test for Poly (lactic-co-glycolic acid) (PLGA) implants predicts real-time peptide release. This method aids quality control for controlled-release drug delivery systems.

Keywords:
Accelerated release methodBiodegradableControlled releaseLong-term releasePLGA

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Area of Science:

  • Pharmaceutical Sciences
  • Biomaterials Science
  • Drug Delivery Systems

Background:

  • Poly (lactic-co-glycolic acid) (PLGA) is a widely used biocompatible polymer for controlled-release (CR) implantable dosage forms.
  • Slow drug release from PLGA implants (months to years) presents challenges for batch release and quality control testing.
  • Accelerated in vitro testing methods are crucial for early formulation development of CR implants.

Purpose of the Study:

  • To develop an accelerated in vitro release testing method for predicting the real-time release of a synthetic peptide from a 6-month CR PLGA implant.
  • To address the unique challenge of an aggregation-prone peptide, ensuring both release kinetics and peptide stability are accurately assessed.
  • To establish a reliable method for guiding formulation and process development of CR PLGA implants.

Main Methods:

  • Evaluation of various conditions including pH, buffer species, temperature, organic co-solvents, and surfactants to optimize peptide release within two weeks.
  • Systematic assessment of parameters to ensure accurate recapitulation of release rate, profile, and peptide stability.
  • Development of a mixed media system comprising 5% tetrahydrofuran, 5% TritonX-100, and PBS (pH 7.4) at 50°C.

Main Results:

  • An optimized accelerated release method using a mixed media of co-solvent, surfactant, and elevated temperature in a neutral buffer was established.
  • The accelerated method achieved complete peptide release within 14-21 days, significantly faster than the 3- to 6-month real-time release.
  • The developed method demonstrated the ability to discriminate critical differences in release behavior between different CR formulations.

Conclusions:

  • The developed accelerated in vitro release testing method accurately predicts real-time peptide release from PLGA implants.
  • This method is particularly valuable for aggregation-prone peptides, ensuring stability and reliable release profile assessment.
  • The accelerated method provides a robust tool for guiding formulation and process development, enhancing quality control for CR PLGA implants.