Toxicological study of fungi isolated from starches intended for human consumption

Area of Science:

• Microbiology
• Ecotoxicology
• Pharmaceutical Science

Background:

• Pharmaceutical manufacturing relies on high-purity raw materials, including starches.
• Microbial contamination of pharmaceutical ingredients poses a significant risk to product safety and efficacy.
• Accurate toxicity testing is crucial for identifying and controlling fungal contaminants.

Purpose of the Study:

• To assess the toxicity of fungal strains isolated from pharmaceutical-grade starches.
• To compare the sensitivity of two biotests for detecting fungal toxicity: Brine shrimp (Artemia salina L.) larvae and Bacillus megaterium NRRL 1 366.
• To identify specific fungal species exhibiting toxicity.

Main Methods:

• Isolation and cultivation of 310 fungal strains from pharmaceutical starches.
• Toxicity assessment using Brine shrimp (Artemia salina L.) larvae bioassay.
• Toxicity assessment using Bacillus megaterium NRRL 1 366 bioassay.
• Comparative analysis of the sensitivity of the two bioassays.

Main Results:

• Out of 310 fungal strains, 82 were toxic to both Brine shrimp larvae and Bacillus megaterium.
• A total of 173 strains (82 + 91) showed toxicity in at least one of the bioassays.
• The Brine shrimp larvae bioassay demonstrated higher sensitivity in detecting fungal toxicity compared to the Bacillus megaterium assay.
• Species-specific toxicity results were also reported.

Conclusions:

• The Brine shrimp (Artemia salina L.) larvae bioassay is a sensitive method for detecting toxic fungi in pharmaceutical starches.
• Routine toxicity screening using Brine shrimp larvae can enhance the safety of pharmaceutical ingredients.
• Understanding species-specific toxicity aids in risk assessment and control strategies for fungal contamination.