Societe Des Produits Nestle S.a.

Zx Pharma, LLC

Physician's Seal, LLC

Fred Hassan

Syed Muzafar Shah

Daniel Hassan

Christopher Richard Diorio

Sarah Hassan

Patrick Corsino

Christopher Diorio

Cannabinoid oil compositions may be used to treat gastrointestinal disorders. An example of the composition is an oral multiparticulate dosage form including a plurality of individual particulates including a solid core with an effective amount of cannabinoid oil bound in microcrystalline cellulose therein and an enteric coating over the solid core.

Oral solid cannabinoid oil composition for treating gastrointestinal disorders

A method of treating a gastrointestinal disorder includes administering to a patient an effective amount of a multiparticulate dosage form including a plurality of individual spheroidal enteric coated cores having a diameter of 0.1 mm to 3 mm. The individual spheroidal enteric coated cores have (a) a core including menthol, (b) a proteinaceous subcoating over the core, and (c) an enteric coating over the proteinaceous subcoating. The multiparticulate dosage form is configured to release most of the menthol in the area of the GI tract where the inflammation is occurring.

Enteric coated multiparticulate compositions with a proteinaceous subcoat

A valerian composition includes valerian and an acidifying agent blended together in a pharmaceutically acceptable hydrogel-forming polymer matrix. An expedited release portion of the dosage form includes 5% to 50% of the valerian and is effective to release the valerian therein within 2 hours from placement in a 0.1 N HCl solution. A sustained release portion of the dosage form includes the remainder of the valerian and is effective to release the valerian therein within 10 hours from placement in a phosphate buffer with a pH of 6.8.

Valerian composition and related methods

A composition includes a pharmaceutical tablet dosage form configured to disintegrate in oral saliva and maintain a pH of 4 or less within the saliva during the time the dosage form is dissolving therein, the dosage form including 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 being sufficient to cause the dosage form to completely disintegrate in the saliva within ten minutes from contacting the saliva.

Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva

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

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.

Method of making an L-menthol dosage form

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.

Multiparticulate L-menthol formulations and related methods

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 &#x3bc;m to 270 &#x3bc;m coated with a polyvinylidene chloride (PVDC) coating having a coating weight of 110 g/mto 130 g/m. An aluminum foil lid closes the cavity and encapsulates the tablet within the blister film and lid. The lid has a thickness of 20 &#x3bc;m to 30 &#x3bc;m.

Packaging for solid dosage forms of melatonin with a high citric acid concentration

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.

A composition includes an oral thin film pharmaceutical dosage form configured to disintegrate 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 polymer carrier matrix and a sufficient amount of acid to impart the pH to the saliva. The dosage can completely disintegrate in the saliva within ten minutes from contacting the saliva.

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.

Controlled-release compositions of melatonin combined with sedative and/or analgesic ingredients

Orally ingestible tablet

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.

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Boca Raton, FL, United States of America

Fred Hassan