Abstract: A composition includes a pharmaceutical dosage form configured to dinsintegrate in saliva and maintain a pH of 4 or less within the saliva during the time the dosage form is dissolving therein. The dosage form includes a therapeutically effective amount of melatonin in a carrier matrix, a disintegrant, and a sufficient amount of acid to impart the pH to the saliva. The amount of disintegrant is sufficient to cause the dosage form to completely disintegrate in the saliva within ten minutes from contacting the saliva.

Abstract: A valerian composition includes a therapeutically effective pharmaceutical dosage form having a solid core including a polymer in which valerian and a valerian stability improving amount of an acidifying agent are contained. The valerian stability improving amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.

Abstract: A valerian composition includes a therapeutically effective pharmaceutical dosage form having a solid core including a polymer in which valerian and a valerian stability improving amount of an acidifying agent are contained. The valerian stability improving amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: A method of making an L-menthol dosage form includes forming a wet granulation including an L-menthol source and at least one pharmaceutical excipient. The wet granulation is extruded into an extrudate and the extrudate is cut into individual core pieces. The individual core pieces are spheronized into individual spheronized cores and the individual spheronized cores are dried to form dried individual spheronized cores. The dried individual spheronized cores are spray coated with a liquid proteinaceous material that forms a film of a proteinaceous material over the dried individual spheronized cores. The film of proteinaceous material is dried over the dried individual spheronized cores to form individual subcoated cores. An enteric coating is applied and dried over the individual subcoated cores to form a plurality of individual enteric coated cores.

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: An oral melatonin pharmaceutical dosage form that contains a sustained release dose of melatonin includes melatonin and an acid dispersed in a hydrogel-forming polymer matrix that combine after ingestion to form an acidic hydrogel containing the melatonin.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: The present invention provides formulations that achieve effective delivery of methylnaltrexone compositions. The provided formulations are useful for preventing, treating delaying, diminishing or reducing the severity of side effects resulting from use of analgesic opioids.

Abstract: A valerian composition includes a therapeutically effective pharmaceutical dosage form having a solid core including a polymer in which valerian and a valerian stability improving amount of an acidifying agent are contained. The valerian stability improving amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: An oral melatonin pharmaceutical dosage form that contains a sustained release dose of melatonin includes melatonin and an acid dispersed in a hydrogel-forming polymer matrix that combine after ingestion to form an acidic hydrogel containing the melatonin. The dosage form is effective to release melatonin therefrom for at least six hours after oral ingestion.

Abstract: Melatonin tablets with a high concentration of citric acid are packaged in a blister package that enhances storage stability. Such a packaging material includes a blister film forming a cavity holding the tablet therein. The blister film includes a polyvinyl chloride (PVC) film having a thickness of 180 ?m to 270 ?m coated with a polyvinylidene chloride (PVDC) coating having a coating weight of 110 g/m2 to 130 g/m2. An aluminum foil lid closes the cavity and encapsulates the tablet within the blister film and lid. The lid has a thickness of 20 ?m to 30 ?m.

Abstract: An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.

Abstract: A composition includes a pharmaceutical dosage form configured to dinsintegrate in saliva and maintain a pH of 4 or less within the saliva during the time the dosage form is dissolving therein. The dosage form includes a therapeutically effective amount of melatonin in a carrier matrix, a disintegrant, and a sufficient amount of acid to impart the pH to the saliva. The amount of disintegrant is sufficient to cause the dosage form to completely disintegrate in the saliva within ten minutes from contacting the saliva.

Abstract: Controlled-release therapeutic compositions including melatonin combined with sedative and/or analgesic ingredients are described. The compositions have a solid core including melatonin in an acidified polymeric matrix. A sedative ingredient such as GABA receptor agonist may also be in the acidified polymeric matrix. The composition may include an expedited release portion providing a burst release of active ingredients and a sustained release portion providing a sustained release of active ingredients.

Abstract: An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.

Abstract: The present invention provides a new forms of (R)-N-methylnaltrexone, and compositions thereof, useful as a peripheral mu opioid receptor antagonist.