Zx Pharma, LLC

Societe Des Produits Nestle S.a.

Sarah Hassan

Syed Muzafar Shah

Daniel Hassan

Fred Hassan

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

Preventing whisker growth from an L-menthol composition

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.

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.

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.

Enteric coated multiparticulate formulations that use L-menthol as an active ingredient are disclosed. In one embodiment, the multiparticulate formulation comprises a plurality of particulates having a reduced release under gastric conditions and an elevated release at neutral pH. The particulates comprise a core comprising L-menthol as an active ingredient. The L-menthol is supplied to the core as an at least 80% pure L-menthol material. An enteric coating is over the core. The enteric coating is effective to release at least about 80% of the L-menthol within about two hours of being placed in a substantially neutral pH environment. Other aspects of the invention include methods of making and methods of using the multiparticulate formulations.

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Boca Raton, FL, United States of America

Sarah Hassan