L-menthol dosage forms having a proteinaceous coating for enhanced storage stability
AssigneeZx Pharma, LLC
InventorsSyed M. Shah, Fred Hassan
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Abstract
A storage stable L-menthol composition including a tablet, caplet, capsule, or sachet dosage form has therein a core containing crystalline L-menthol and at least one pharmaceutical excipient. A proteinaceous coating of a continuous film of proteinaceous material is over the core. The film is effective to substantially prevent the crystalline L-menthol from volatilizing and leaving the core when stored at a temperature of 40 degrees C. and 75% relative humidity from between 1 day to 30 days. The dosage form contains an effective amount of the crystalline L-menthol for treating a gastrointestinal disorder.
Claims33
A storage stable L-menthol composition comprising a multiparticulate dosage form having:
- a plurality of individual cores containing crystalline L-menthol and at least one pharmaceutical excipient;
- and
- a proteinaceous coating of a continuous film of proteinaceous material over the cores forming a plurality of proteinaceous coated individual cores, the film being effective to substantially prevent the crystalline L-menthol from volatilizing and leaving the proteinaceous coated individual cores when stored at a temperature of 40 degrees C. and 75% relative humidity from between 1 day to 30 days;
- wherein the dosage form contains an effective amount of the crystalline L-menthol for treating a gastrointestinal disorder;
- wherein an enteric coating over the proteinaceous coated individual cores prevents the L-menthol from releasing into the stomach and allows the L-menthol to release into the intestines;
- and
- wherein the proteinaceous coating is 3.5% to 35% w/w of the individual enteric coated cores.
Dependencies are inferred from the claim text.