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.

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: A pharmaceutical dosage form includes an effective amount of L-menthol for treating a gastrointestinal disorder. The L-menthol is within a plurality of particulates having a core including crystalline L-menthol dissolved in a terpene-based essential oil. A proteinaceous coating of a continuous film of proteinaceous material is over the core.

Abstract: 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.

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: A method of treating a human subject in need of melatonin therapy comprises administering to a human subject a composition comprising melatonin dispersed in a polymer matrix adapted to cover the melatonin in a melatonin solubility enhancing pH environment after ingestion and to maintain the melatonin solubility enhancing pH environment when said composition is present in said subject's intestines so that an effective amount of melatonin is released into the subject's intestines.

Abstract: A multiparticulate dosage form includes a plurality of individual spheroidal enteric coated particulates having (a) a diameter of 0.1 to 2.5 mm; (b) a solid core containing an effective amount of a combination of an L-menthol source and a terpene-based essential oil; (c) a continuous proteinaceous subcoating over the core; and (d) an enteric coating over the subcoating. The multiparticulate dosage form can be used to treat gastrointestinal disorders.

Abstract: 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.

Abstract: A melatonin-containing product includes a composition comprising melatonin, a pH lowering agent, and a gel-forming forming polymer. When ingested, the composition forms an acidic aqueous gel matrix having melatonin dissolved therein for releasing melatonin into the intestines for a sustained time period.

Abstract: A multiparticulate formulation includes a plurality of individual spheroidal enteric coated cores containing L-menthol from an at least 80% pure L-menthol source. A subcoat is beneath the enteric coat. The enteric coated cores have a diameter of not more than 3 mm. The multiparticulate formulation may be used to treat gastrointestinal disorders, such as irritable bowel syndrome.

Abstract: An L-menthol-containing multiparticulate formulation includes a plurality of individual enteric coated cores containing L-menthol from an at least 80% pure L-menthol source. The enteric coated cores are effective to release at least about 35% of the L-menthol within about two hours, and at least about 80% of the L-menthol within about eight hours after being placed in an environment having a pH of 5 to 8. The L-menthol multiparticulate formulation can be used to treat gastrointestinal disorders.

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: 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.

Abstract: 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.

Abstract: Enteric coated multiparticulate compositions that use a L-carnitine compound an active ingredient are disclosed. The multiparticulates have spheroidal core comprising a L-carnitine, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methyl cellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: A melatonin-containing product includes a composition comprising melatonin, a pH lowering agent, and a gel-forming forming polymer. When ingested, the composition forms an acidic aqueous gel matrix having melatonin dissolved therein for releasing melatonin into the intestines for a sustained time period.

Abstract: A method of treating a human subject in need of melatonin therapy comprises administering to a human subject a composition comprising melatonin dispersed in a polymer matrix adapted to cover the melatonin in a melatonin solubility enhancing pH environment after ingestion and to maintain the melatonin solubility enhancing pH environment when said composition is present in said subject's intestines so that an effective amount of melatonin is released into the subject's intestines.

Abstract: This disclosure relates to controlled-release melatonin compositions and related methods. In one embodiment, a controlled-release medicament composition comprises melatonin dispersed in a controlled melatonin release portion comprising a polymer matrix, the polymer matrix adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment and to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment.

Abstract: A multiparticulate formulation includes a plurality of individual spheroidal enteric coated cores containing L-menthol from an at least 80% pure L-menthol source. A subcoat is beneath the enteric coat. The enteric coated cores have a diameter of not more than 3 mm. The multiparticulate formulation may be used to treat gastrointestinal disorders, such as irritable bowel syndrome.