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

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 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).

Conclusions:

The test article containing budesonide 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.

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