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Xiaowei Dong1, Cynthia A Mattingly, Michael Tseng

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New lipid-based paclitaxel (PX) nanoparticles were developed without Cremophor. Optimized formulations showed high drug loading, stability, and anticancer activity, with one type lyophilizing effectively.

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Area of Science:

  • Pharmaceutical Nanotechnology
  • Drug Delivery Systems
  • Cancer Therapeutics

Background:

  • Paclitaxel (PX) is a potent chemotherapy agent with poor solubility.
  • Conventional formulations often use Cremophor EL, leading to hypersensitivity reactions.
  • Development of Cremophor-free nanoparticle formulations is crucial for improved patient outcomes.

Purpose of the Study:

  • To develop novel, Cremophor-free, lipid-based paclitaxel (PX) nanoparticle formulations.
  • To optimize nanoparticle formulations using a combination of Taguchi array and sequential simplex optimization.
  • To characterize the physicochemical properties, stability, drug release, and in vitro cytotoxicity of the developed nanoparticles.

Main Methods:

  • Utilized warm microemulsion precursors for nanoparticle preparation.
  • Employed Taguchi array and sequential simplex optimization for efficient formulation design.
  • Characterized nanoparticles for drug loading, entrapment efficiency, particle size, physical stability, and in vitro drug release.
  • Assessed cytotoxicity in MDA-MB-231 cancer cells and evaluated lyophilization capabilities.

Main Results:

  • Two optimized paclitaxel nanoparticle formulations (G78 NPs and BTM NPs) were successfully developed.
  • Both formulations achieved high paclitaxel entrapment (>85%) and drug loading (>6%), with particle sizes <200 nm.
  • Nanoparticles exhibited excellent physical stability and sustained drug release without an initial burst.
  • Cytotoxicity studies confirmed comparable anticancer activity to Taxol, and BTM nanocapsules showed successful lyophilization without cryoprotectants.

Conclusions:

  • Novel Cremophor-free lipid-based paclitaxel nanoparticles were efficiently designed and optimized.
  • The developed nanoparticles possess favorable characteristics including stability, sustained release, and potent anticancer activity.
  • The BTM nanocapsule formulation offers the advantage of stable lyophilization, enhancing its therapeutic potential.