An innovative one step green supercritical CO2 process for the production of liposomes co-encapsulating both a hydrophobic and a hydrophilic compound for pulmonary administration

Int J Pharm. 2022 Nov 5:627:122212. doi: 10.1016/j.ijpharm.2022.122212. Epub 2022 Sep 21.

Abstract

Budesonide and salbutamol-loaded liposomes were prepared using an innovative one step supercritical CO2 method without any use of organic solvents. Liposomes composed of soybean phosphatidylcholine, cholesterol and PEGylated lipid (65/30/5% (m/m)) were produced with a size less than 200 nm, a PdI within the range of 0.3 and 0.35 and encapsulation efficiency for budesonide and salbutamol reaching to 94% and 40% respectively. The physical stability of the formulation was improved by optimizing a dry form by freeze-drying with trehalose in a 20:1 (trehalose:lipid) ratio and an increase in the percentage of PEGylated lipid from 5% to 15%. This dry form stored at 4 °C maintains 90-110% of the initial concentration of active compounds. The concentration of budesonide and salbutamol after 15 weeks was 522.92 ± 73.01 µg/mL and 144.86 ± 31.22 µg/mL respectively. These concentrations are close to the concentrations of these molecules in the pharmaceutical products Pulmicort® (500 µg/mL of budesonide) and Ventolin® (100 µg/dose). The formulation tested on lung cells, allows a cell viability of 71 ± 6%, which is not significantly different from untreated cells.

Keywords: Budesonide; Co-encapsulation; Drug delivery; Encapsulation method; Green process; Liposome; Salbutamol; Supercritical carbon dioxide.

MeSH terms

  • Albuterol
  • Budesonide
  • Carbon Dioxide* / chemistry
  • Cholesterol
  • Liposomes* / chemistry
  • Particle Size
  • Phosphatidylcholines
  • Polyethylene Glycols
  • Solvents
  • Trehalose

Substances

  • Liposomes
  • Carbon Dioxide
  • Trehalose
  • Budesonide
  • Albuterol
  • Phosphatidylcholines
  • Cholesterol
  • Solvents
  • Polyethylene Glycols