The Impact of Handling and Storage of Human Fecal Material on Bacterial Activity

Area of Science:

• Microbiology
• Pharmacology
• Drug Delivery

Background:

• Human fecal material is crucial for assessing bacterial degradation of active pharmaceutical ingredients (APIs).
• This is vital for predicting drug behavior and efficacy within the colon.
• Understanding sample handling is key to reliable colonic drug delivery assessments.

Purpose of the Study:

• To investigate the effects of handling and storage on the bacterial activity in human fecal material.
• To determine optimal conditions for preserving bacterial degradation capacity for drug metabolism studies.

Main Methods:

• Assessed degradation of metronidazole and olsalazine using human fecal material.
• Evaluated the impact of multiple freeze-thaw cycles on bacterial activity.
• Tested incubation in an anaerobic workstation to restore bacterial function.
• Determined the maximum storage duration at -70°C.

Main Results:

• Multiple freeze-thaw cycles significantly reduce bacterial degradation activity.
• A 2-hour incubation in an anaerobic workstation effectively regenerates bacterial activity.
• Human fecal material can be stored at -70°C for at least 12 months with preserved activity.

Conclusions:

• Proper handling and storage are essential for maintaining the integrity of fecal material for drug degradation studies.
• Short-term incubation can restore bacterial activity in previously frozen samples.
• Long-term storage at -70°C is feasible for preserving the utility of fecal material for colonic drug delivery research.