Abstract
Particle size of Beclometasone Dipropionate (BDP) was reduced by the rapid expansion of supercritical solution (RESS) process, using CO2 as supercritical solvent. Also, the effect of RESS parameters such as extraction pressure, pre-expansion temperature, and weight fraction of co-solvent on the size and distribution of BDP particles were investigated. The effects of extraction pressure (200-260 bar), pre-expansion temperature (70-110 °C) and weight fraction of menthol as a co-solvent on mean particle size (MPS) of BDP were investigated by design of experiment (DOE). Particles were characterized using Scanning Electron Microscopy (SEM) and Dynamic Light Scattering (DLS). The average sizes of precipitated BDP were between 64.1 and 294 nm. Analysis of variance (ANOVA) showed that extraction pressure was the most significant parameter and a higher extraction pressure caused production of smaller particles. Also, it was found that higher temperature and weight fraction of co-solvent increased the MPS. The interaction effects of extraction pressure-pre-expansion temperature and pre-expansion temperature-co-solvent ratio were significant through the analysis of variance. It was observed that the MPS of precipitated particles was mostly influenced by pressure. The smallest MPS of BDP obtained from the RESS process was 65 nm that revealed a significant size reduction from its original MPS of 9 μm. Moreover, a slight change was observed for precipitated particles of BDP into spherical form while the original particles were irregular in shape. RESS process showed as a promising method for production of BDP nanoparticles that may results in improvement of drug's physicochemical properties.
Highlights
Supercritical fluid (SCF) technology has become an important tool of materials processing in several pharmaceutical operations including crystallization, particle size reduction, coating and product sterilization
rapid expansion of supercritical solution (RESS) process showed as a promising method for production of Beclometasone Dipropionate (BDP) nanoparticles that may results in improvement of drug’s physicochemical properties
The smallest mean particle size (MPS) obtained from the RESS process was 64.09 nm and its Scanning Electron Microscopy (SEM) image and Dynamic Light Scattering (DLS) analysis are shown in Figure 1(b) and Figure 3, respectively
Summary
Supercritical fluid (SCF) technology has become an important tool of materials processing in several pharmaceutical operations including crystallization, particle size reduction, coating and product sterilization. The advantages of SCF technology in the particle design include application of mild conditions, use of environmentally benign nontoxic fluids (such as CO2), minimization of organic solvents and production of particles with controllable morphology, narrow size distribution and low static charge.[1,2,3,4] Depending on the raw material and the final product, different supercritical processes are employed to produce fine particles. Rapid expansion of supercritical solution (RESS) is a dominant method for production of nano and micro size drugs.[5,6] In this method carbon dioxide acts as a solvent due to its moderate supercritical conditions (31.1°C and 73.8 bar), non-toxic, non-flammable, environmentally friendly and inexpensive characters.[6] The RESS process consists of pre-extraction, extraction, and precipitation units and it includes the entering of CO2 into the dissolve chamber (pre-extraction unit), saturation of the supercritical fluid with drug (extraction unit) and pressure reduction of the solution through a heated nozzle (precipitation unit). The effect of RESS parameters such as extraction pressure, pre-expansion temperature, and weight fraction of co-solvent on the size and distribution of BDP particles were investigated
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