SUMMARY

  • • With more than 10 liposomal products on the market and a greater than 20-year history for one (AmBisome), liposomes have a good track record of safety.
  • • High-quality lipids with registered DMFs are available from multiple suppliers. Manufacturing of liposomes has become routine and predictable.

The analytical characterization of liposomal products is more complex than for standard solution formulations; however, the analytical methodology is routine in most well-equipped pharmaceutical laboratories.

  • Inhaled liposome-encapsulated drugs offer reduced systemic toxicity compared to inhalation of formulations of the free drug. Other potential advantages include better tolerability, a modified release profile, and improved compliance due to less frequent dosing.
  • • The extensive interest in inhaled liposomes in the late 1980s and early 1990s answered many of the fundamental in vitro formulation and delivery questions and increased the comfort level with in vivo exposure to liposomes in the respiratory tract.
  • • The most straightforward path to create liposomal aerosols is using jet or mesh nebulization, and two late-stage inhaled liposomal antibiotics have chosen these delivery modalities.
  • Inhaled liposomal amikacin and liposomal ciprofloxacin both demonstrate increased residence time in the lung and delayed systemic uptake, as compared to unencapsulated antibiotic formulations, and may be approved to treat lung infections in the near future.
 
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