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Formulation of insulin-loaded polymeric nanoparticles using response surface methodology.

D Attivi1, P Wehrle, N Ubrich

  • 1Laboratoire de Pharmacie, Galénique et Biopharmacie, Faculté de Pharmacie, Nancy Cedex, France.

Drug Development and Industrial Pharmacy
|March 19, 2005
PubMed
Summary

New oral insulin nanoparticles were developed using biodegradable poly-epsilon-caprolactone (PCL) and Eudragis RS polymers. The optimized formulation demonstrated potential for effective oral insulin delivery, with entrapped insulin and controlled release characteristics.

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Area of Science:

  • Pharmaceutical Sciences
  • Biomaterials Engineering
  • Drug Delivery Systems

Background:

  • Oral insulin delivery faces challenges due to enzymatic degradation and poor absorption in the gastrointestinal tract.
  • Nanoparticle-based systems offer a promising strategy to protect insulin and enhance its oral bioavailability.
  • Biodegradable and functionalized polymers are crucial for developing stable and effective insulin-loaded nanoparticles.

Purpose of the Study:

  • To formulate and optimize novel oral insulin-loaded nanoparticles using biodegradable poly-epsilon-caprolactone (PCL) and positively-charged Eudragis RS polymers.
  • To investigate the impact of polymer ratio, polyvinyl alcohol solution volume, and pH on nanoparticle characteristics using response surface methodology.
  • To evaluate the entrapment efficiency, particle size, polydispersity, zeta potential, and in vitro insulin release of the developed nanoparticles.

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Main Methods:

  • Insulin-loaded nanoparticles were prepared via a water-in-oil-in-water emulsification and evaporation technique.
  • A central composite design was employed to study the effects of polymer ratio (PCL/RS), aqueous solution volume, and pH.
  • Nanoparticle characterization included measuring entrapped insulin, particle size, polydispersity, zeta potential, and 7-hour insulin release.

Main Results:

  • Response surface methodology successfully identified an optimal operating area for nanoparticle formulation.
  • The optimized PCL/RS 50/50 nanoparticles exhibited an entrapped insulin content of 25 IU/100 mg, particle size of 350 nm, and polydispersity of 0.21.
  • In vitro release studies showed 4.8 IU/100 mg of insulin released after 7 hours, with a zeta potential of +44 mV, aligning with model predictions.

Conclusions:

  • The developed PCL/RS nanoparticles show significant promise as a formulation for oral insulin delivery.
  • The response surface methodology effectively optimized the formulation parameters for desirable nanoparticle characteristics.
  • The positively-charged nanoparticles demonstrate potential for enhanced mucoadhesion and improved oral absorption of insulin.