Evaluation of an oral Beta-caryophyllene Indena Phytosome® for the treatment of pain and inflammation in interstitial cystitis.

BackgroundInterstitial cystitis (IC), a chronic inflammatory condition of the urinary bladder characterized by pain and difficulties with urination, has limited treatment options. Beta-caryophyllene (BCP) is a sesquiterpene with anti-inflammatory and analgesic properties, but has poor water solubility and limited intestinal absorption which may limit oral bioavailability. Indena Phytosome® is a proprietary food-grade lecithin-based delivery system that optimizes the bioavailability and pharmacokinetic profile of natural phytochemicals like BCP by producing a stable solid dispersion suitable for oral delivery.ObjectiveTo examine the therapeutic potential of an oral BCP Indena Phytosome® formulation (BCP Indena Phytosome®) for the treatment of IC.MethodsFemale BALB/c mice were pre-treated with BCP Indena Phytosome® or empty Indena Phytosome® vehicle, then IC was induced using lipopolysaccharide. 24 h later, inflammation was evaluated using intravital microscopy and histology. Pain was evaluated using behavior scoring and von Frey asethesiometry.ResultsPre-treatment with BCP Indena Phytosome® reduced leukocyte adhesion, histology scores, and behavior scores in IC mice, indicating a reduction in inflammation and pain. Lipopolysaccharide administration did not alter leukocyte rolling, capillary perfusion, or von Frey scores.ConclusionsOral BCP Indena Phytosome® effectively reduces pain and inflammation in experimental IC by decreasing leukocyte adhesion and extravasation in the bladder.