Definition

A formulation composed of enteric-coated, sustained-release (SR) microspheres containing ultrapurified peppermint oil (Mentha piperita), a naturally-occurring carminative herb containing monoterpene compounds, with potential calming, anti-bacterial, anti-inflammatory, analgesic and anti-spasmodic activities. Upon oral administration of the peppermint oil-containing enteric-coated microspheres, the formulation allows for an initial quick release of peppermint oil in the small intestine and after that it is released throughout the small intestine over an extended period of time from the individual microspheres. The L-menthol in this formulation targets and blocks calcium channels in smooth muscle in the small intestine, thereby producing an anti-spasmodic effect on the gastrointestinal tract (GI). This allows for relaxation of smooth muscle and helps calm uncontrolled spasms. This may normalize digestion, decrease pain and discomfort, prevents cramping, bloating, diarrhea and constipation. L-menthol’s kappa opioid agonist activity may further reduce abdominal pain and cramping. Through its anti-microbial effect, L-menthol may promote bacterial balance in the small intestine. The anti-inflammatory activity of L-menthol prevents inflammation associated with gut mucosal barrier disruption. Additionally, this formulation contains fiber and amino acids, which may further improve the integrity of the mucosal barrier.