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Preventing agglomeration of doxorubicin-loaded polymeric nanoparticles (PNP) is key for drug delivery. This study found that lyophilization with glucose or sucrose allows stable storage of PDIBG and PDIPG nanoparticles for two months.

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Area of Science:

  • Polymer chemistry
  • Nanotechnology
  • Pharmaceutical sciences

Background:

  • Polymeric nanoparticles (PNP) are crucial for drug delivery.
  • Preventing nanoparticle agglomeration during storage is essential for maintaining efficacy.
  • Doxorubicin (DOX)-loaded nanoparticles require stable formulations for long-term use.

Purpose of the Study:

  • To investigate optimal conditions for maintaining the size of doxorubicin (DOX)-loaded poly-(diisobutyl glycolide) (PDIBG) and poly-(diisopropyl glycolide) (PDIPG) nanoparticles (NP) during long-term storage.
  • To evaluate the impact of lyophilization on the stability of DOX-loaded PDIBG and PDIPG NPs.
  • To determine effective cryoprotectants for stabilizing lyophilized nanoparticles.

Main Methods:

  • Synthesis of PDIBG and PDIPG homopolymers.
  • Production of DOX-loaded NPs using single-emulsion solvent evaporation.
  • Optimization of nanoparticle formulations for size and encapsulation efficiency.
  • Lyophilization of NPs at different concentrations and freezing temperatures (-20 and -50 °C).
  • Assessment of nanoparticle size and PDI after storage at 4 °C and -20 °C for 2 months, with and without cryoprotectants (glucose and sucrose).

Main Results:

  • Optimal DOX-loaded PDIBG NPs: 253 ± 7 nm size, 0.06 ± 0.02 PDI, 58.3% EE.
  • Optimal DOX-loaded PDIPG NPs: 253 ± 7 nm size, 0.08 ± 0.04 PDI, 73.9% EE.
  • Lyophilization with 5% or 10% glucose and sucrose enabled stable storage of DOX-loaded PDIBG and PDIPG NPs for 2 months at 4 °C and -20 °C.
  • Maintained particle size and PDI values were observed in the presence of cryoprotectants.

Conclusions:

  • Lyophilization is an effective method for stabilizing DOX-loaded PDIBG and PDIPG nanoparticles.
  • Glucose and sucrose act as effective cryoprotectants, preventing agglomeration and maintaining nanoparticle integrity during storage.
  • Stable storage conditions were established for drug-loaded polymeric nanoparticles, enhancing their potential for pharmaceutical applications.