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Corticosteroid microparticles produced by supercritical-assisted atomization: process optimization, product characterization, and "in vitro" performance.

Abstract：

:In this work, the production of dexametasone and dexametasone acetate microparticles is proposed using supercritical-assisted atomization (SAA). This process is based on the solubilization of supercritical carbon dioxide in a liquid solution containing the drug; then, the ternary mixture is sprayed through a nozzle and submicroparticles are formed as a consequence of the enhanced atomization. Several process parameters such as different organic solvent (methanol and acetone), solute concentration and flow rate ratio between the liquid solution and carbon dioxide are investigated; their influence is evaluated on the morphology and size of precipitated particles. Spherical corticosteroid particles with mean diameters ranging from 0.5 to 1.2 microm are produced at the optimum operating conditions and narrow particle size distributions (PSDs) have also been obtained. No drug degradation was observed after SAA processing and solvent residues of 300 and 500 ppm for acetone and methanol, respectively, were measured. Drug microparticles produced by SAA can be semi-crystalline or amorphous depending on the process condition; a micronized drug surface area ranging from about 4 to 5 m2/g was also observed. The "in vitro" activity of both untreated and SAA processed glucocorticoids was tested on the release of pro-inflammatory cytokines from stimulated cells. The results shown that SAA-glucocorticoids have retained the activity of the parent untreated compounds and, in the case of dexamethasone, SAA processing improves drug performance.

journal_name

J Pharm Sci

journal_title

Journal of pharmaceutical sciences

authors

Della Porta G,Ercolino SF,Parente L,Reverchon E

doi

10.1002/jps.20703

subject

Has Abstract

pub_date

2006-09-01 00:00:00

pages

2062-76

issue

9

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)32089-5

journal_volume

95

pub_type

杂志文章

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