Enteric coated multiparticulate composition with proteinaceous subcoat

摘要

A multiparticulate composition includes a plurality of individual enteric coated cores containing one or more terpene-based active ingredients and having a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings. The continuous proteinaceous subcoating layer prevents volatile terpene-based active ingredients from leaving the core, even when the core is heated during processing or stored for long periods above room temperature. The multiparticulate composition may be used to treat gastrointestinal disorders.

主权项

1. A method of treating a gastrointestinal disorder in a human subject, the method comprising administering to the subject a multiparticulate dosage form composition in an effective amount to treat a gastrointestinal disorder in the subject, the composition comprising a plurality of individual enteric coated cores containing one or more terpene-based active ingredients and a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings;
the continuous proteinaceous subcoating layer being effective to prevent the terpene-based active ingredient(s) from substantially penetrating through the subcoating layer and contacting the enteric coating when stored at a temperature of 40 degrees C. and 75% relative humidity from between 1 day to 30 days; and the continuous proteinaceous subcoating layer being 3.5% w/w to 35% w/w of the individual enteric coated cores.