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Wednesday, 30 October 2013 16:50

Technical Report: Antimicrobial Effectiveness Testing of a Budesonide LoxaSperse™ Dispersion

PCCA tested the performance of PCCA Formula #10341 (budesonide 0.5 mg in a LoxaSperse mixture) and measured its efficacy against microbial activity when mixed with sterile water.

Introduction:

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LoxaSperse is a powder excipient base used for nebulization and irrigation. LoxaSperse is a blend of specially micronized xylitol with an optimized ratio of micronized poloxamers, designed to improve the dispersability and solubility of APIs (PCCA, 2013). The use of xylitol and poloxamers in nebulization and irrigation is thoroughly referenced in the literature and there is ample evidence of their safety and efficacy (Durairaj et al., 2006; Jagannath et al., 1995; Plataki et al., 2011; Zabner et al., 2000). Budesonide is a corticoid with mainly glucocorticoid activity (Martindale 35, 2007). PCCA tested the performance of Formula #10341, budesonide 0.5 mg in a LoxaSperse mixture, and measured its efficacy against microbial activity when mixed with sterile water.

Abstract:

LoxaSperse is a powder excipient base used for nebulization and irrigation designed to improve dispersability and solubility of Active Pharmaceutical Ingredients (APIs). PCCA tested the performance of PCCA Formula #10341 (budesonide 0.5 mg in a LoxaSperse mixture) and measured its efficacy against microbial activity when mixed with sterile water. The intent is not to determine efficacy of budesonide as an antimicrobial. The Antimicrobial Effectiveness Test (AET) was conducted at 0.5h, 6h, 28h and 168h – serially diluted, and plated for colony counts. Budesonide LoxaSperse dispersions required 0.5h to 28h to significantly reduce the number of viable bacterial cells (E. coli, S. aureus and P. aeruginosa). The results of this study demonstrate that accidental or intentional contamination of the finished or reconstituted preparation did not result in microbial growth.

Conclusions:

The test article containing budesonide and LoxaSperse required 0.5h to 28h to significantly reduce the number of viable bacteria (E. coli, S. Aureus and P. aeruginosa). A. niger showed a decrease in the number of viable cells up to 168h. The chosen formula when intentionally contaminated with microorganisms specified in USP 51 resisted microbial growth. Further, this study demonstrated this formulation after reconstituted was not at risk or did not support microbial growth.

Download the complete PDF detailing the results of this study.

Click to learn more about LoxaSperse.