Evaluation of supercritical fluid engineered budesonide powder for respiratory delivery using nebulisers.
OBJECTIVE
Currently, suspensions prepared from micronised drug substances are the only delivery system marketed for nebulisation of steroids, and reported inconsistent or low bioavailability arising from their use provides a rationale for researching alternative formulations. Supercritical fluid processing of drug substances to obtain respirable-sized particles has been used over the last decade to formulate dry powder inhalers. We aimed thus to process budesonide powder to improve its deposition characteristics.


METHODS
In an attempt to overcome the limitations of nebuliser suspensions when prepared from micronised drug particles, budesonide powder was processed using a supercritical fluid based process and suspended using Tween 80 as a surfactant to provide an aqueous nebuliser formulation. The in-vitro characteristics of the emitted dose on nebulisation for the prepared suspension were then compared to a commercially available suspension formulation of budesonide using a jet and a vibrating mesh nebuliser.


RESULTS
The results showed a significant improvement of the in-vitro deposition properties of the suspension containing supercritical fluid engineered budesonide particles.


CONCLUSIONS
The results indicated the benefit of such materials compared with traditionally micronised drug powders.
Amani
Amir
A
Institute of Pharmaceutical Innovation, School of Pharmacy, University of Bradford, UK. aamani@sina.tums.ac.ir
Chrystyn
Henry
H
Clark
Brian J
BJ
Abdelrahim
Mohamed E
ME
York
Peter
P
D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000737:chemistry; D019819:Budesonide / Q000008:administration & dosage / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D025924:Chromatography, Supercritical Fluid / Q000379:methods*; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011136:Polysorbates; D011208:Powders / Q000737:chemistry / Q000592:standards*; D012137:Respiratory System; D013501:Surface-Active Agents; D013535:Suspensions / Q000592:standards
D001993:Bronchodilator Agents; D011136:Polysorbates; D011208:Powders; D013501:Surface-Active Agents; D013535:Suspensions; D019819:Budesonide