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Rosuvastatin calcium nanoparticles: Improving bioavailability by formulation and stabilization codesign.

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Summary

This study successfully prepared Rosuvastatin calcium nanoparticles using wet milling, significantly improving drug dissolution and bioavailability. Polyvinylpyrrolidone (PVP) stabilized nanoparticles showed enhanced solubility and pharmacokinetic parameters.

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Area of Science:

  • Pharmaceutical Nanotechnology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Rosuvastatin calcium (ROSCa) exhibits poor water solubility and low oral bioavailability (<20%).
  • Particle size reduction is a key strategy to enhance solubility, dissolution rate, and bioavailability of poorly soluble drugs.
  • Nanoparticle formulation offers a promising approach to overcome these limitations.

Purpose of the Study:

  • To prepare Rosuvastatin calcium (ROSCa) nanoparticles using a wet milling technique.
  • To investigate the formulation and stabilization of ROSCa nanoparticles for improved dissolution and bioavailability.
  • To evaluate the impact of nanoparticle engineering on the pharmacokinetic profile of ROSCa.

Main Methods:

  • ROSCa nanosuspensions were prepared via wet milling using a planetary ball mill (0.1 mm balls, 800 rpm, 3 cycles of 10 min).
  • Various stabilizers including HPMC, PVP k-30, pluronic F-127, Tween 80, and PEG 6000 were screened.
  • Nanosuspensions were freeze-dried, and resulting nanoparticles were characterized for particle size, zeta potential, in-vitro dissolution, XRPD, and in-vivo pharmacokinetics.

Main Results:

  • The optimal formula (P3) utilized 10% PVP, yielding stable nanoparticles with a mean particle size of 461.8 ± 16.68 nm, significantly smaller than the untreated drug (618 μm).
  • In-vitro dissolution of ROSCa nanoparticles reached 72% within 1 hour, a substantial increase compared to 58.25% for untreated ROSCa (P < 0.05).
  • In-vivo studies demonstrated a significant enhancement in Cmax (82.35 ng/ml at 2 h) for the nanoparticle formulation versus untreated ROSCa (9.2 ng/ml).

Conclusions:

  • Wet milling is an effective technique for producing Rosuvastatin calcium nanoparticles.
  • Polyvinylpyrrolidone (PVP) at 10% concentration proved to be an effective stabilizer, yielding nanoparticles with improved physical characteristics.
  • The developed ROSCa nanoparticles exhibit significantly enhanced dissolution rates and improved pharmacokinetic parameters, indicating potential for increased bioavailability.