Societe Des Produits Nestle S.a.

Zx Pharma, LLC

Physician's Seal, LLC

Daniel Hassan

Syed Muzafar Shah

Fred Hassan

Christopher Richard Diorio

Sarah Hassan

Patrick Corsino

Christopher Diorio

An L-menthol 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 and an enteric coating over the core. The core includes an L-menthol source that is at least 80% pure L-menthol. The dosage form may be used to treat gastrointestinal disorders, such as irritable bowel syndrome.

Multiparticulate L-menthol formulations and related methods

A composition comprises a therapeutically effective oral pharmaceutical dosage form. The dosage form includes an aqueous carrier material having an acidic pH and a plurality of individual pellets having a first dose of melatonin therein. The individual pellets comprises (i) a solid core; (ii) an active coating over the solid core, the active coating including melatonin and a hydrophilic binder; and (iii) an enteric coating over the active coating. A dissolution pH of the enteric coating is higher than the acidic pH of the aqueous carrier material.

Dosage form with sustained release melatonin pellets

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

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.

Controlled-release melatonin compositions 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 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.

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

Daniel Hassan