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Research articles

ScienceAsia 37 (2011): 31-37 |doi: 10.2306/scienceasia1513-1874.2011.37.031


Development of budesonide suspensions for use in an HFA pressurized metered dose inhaler


Nichakorn Sukasamea, Prapaporn Boonmea,b, Teerapol Srichanaa,b,*

 
ABSTRACT:     The aim of this study was to develop budesonide as a suspension-based pressurized-metered dose inhaler (pMDI) using hydrofluoroalkanes (HFAs) propellants (HFA 134a, HFA 227, and HFA mixture) and stabilizing agents (oleic acid and sorbitan trioleate). A factorial design method was applied to investigate the effects of two factors (vapour pressure of the propellant system and concentration of stabilizing agents) on formulation performances. Each factor was studied in three levels. Twenty four designed formulations of budesonide suspension-based pMDI were prepared. The results indicated that the vapour pressure of the propellant system was an important factor that affected the content of the active ingredient (p<0.05). The formulations containing HFA 134a (high level vapour pressure) gave drug contents above the maximum limit (>120%), whereas the formulations containing HFA 227 (low level vapour pressure) gave low budesonide contents of approximately 50%. However, when a propellant mixture with intermediate vapour pressure was used, the budesonide contents were close to the acceptable range (80–120%). Consequently, the eight formulations containing the HFA mixture together with different types and concentrations of stabilizing agent were tested for their aerosol properties. The fine particle fraction measured by a twin-stage liquid impinger ranged between 32–38%. The mass median aerodynamic diameters obtained from the Andersen cascade impactor were approximately 3 µm for all formulations. No significant difference was found among those formulations. After 3 months of storage, the aerosol properties did not change, and good physical stability was achieved. The particulate budesonide was able to readily re-disperse in the HFA mixture and a homogeneous suspension could be maintained for up to 20 min.

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a Drug Delivery System Excellence Centre, Prince of Songkla University, Hat Yai, Songkhla 90112, Thailand
b Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Songkhla 90112, Thailand

* Corresponding author, E-mail: teerapol.s@psu.ac.th

Received 27 Jun 2010, Accepted 15 Feb 2011