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Novel simvastatin inhalation formulation and characterisation.

Alaa S Tulbah1, Hui Xin Ong, Paolo Colombo

  • 1Respiratory Technology, Woolcock Institute of Medical Research and Discipline of Pharmacology, Sydney Medical School, Sydney University, Sydney, NSW, 2037, Australia.

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Summary
This summary is machine-generated.

A new inhalable simvastatin (SV) formulation using a pressurized metered-dose inhaler (pMDI) was developed. This stable SV pMDI offers potential as an inhaled anti-inflammatory therapy for lung diseases.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery
  • Respiratory Medicine

Background:

  • Simvastatin (SV), a statin, reduces cholesterol by inhibiting HMG-CoA reductase.
  • SV possesses anti-inflammatory properties potentially beneficial for airway diseases.
  • Currently, no inhalable formulation exists for direct lung delivery of SV.

Purpose of the Study:

  • To develop and characterize a novel pressurized metered-dose inhaler (pMDI) solution formulation of simvastatin (SV).
  • To evaluate the aerosol performance and chemical stability of the SV pMDI for inhalation therapy.
  • To assess the suitability of the SV pMDI for treating lung inflammatory diseases.

Main Methods:

  • Manufactured a simvastatin solution pMDI formulation with 6% ethanol as a co-solvent.
  • Assessed simvastatin solubility, aerosol performance via Andersen Cascade Impactor, and chemical stability up to 6 months.
  • Characterized physico-chemical properties using DSC, TGA, laser diffraction, and SEM for aerosol morphology.

Main Results:

  • The simvastatin pMDI formulation exhibited suitable aerosol particle size distribution for inhalation.
  • A fine particle fraction of 30.77 ± 2.44% was achieved.
  • The formulation demonstrated short-term chemical stability up to 6 months at 4°C and 3 months at 25°C.

Conclusions:

  • A stable, respirable simvastatin solution pMDI formulation for inhalation has been successfully developed.
  • This novel formulation holds potential for clinical application as an inhaled anti-inflammatory treatment for various lung diseases.
  • The study presents a promising new delivery method for simvastatin in respiratory medicine.