Abstract: Embodiments of the disclosure relate generally to formulations, methods of treatment, kits, and dosage forms for treating inflammatory disorders, including topic dermatitis, cancer, the formulations comprising an active pharmaceutical ingredient. The formulation provided comprises granules, wherein the granules comprise: micronized active ingredient; one or more granulation binders; one or more fillers; one or more disintegrants; and one or more antioxidants. In one embodiment, the methods of treatment include orally administering the active ingredient to a subject suffering from atopic dermatitis, where the active ingredient, is in an amount of about 20 mg to about 80 mg.

Abstract: The present application provides improved compositions, methods, kits and dosing regimens for the use of heterocyclic compounds and pharmaceutically acceptable salts, prodrugs, solvates, hydrates, or stereoisomers thereof. These compositions, methods, kits and dosing regimens are useful for modulating ERK1/2. By administering to a subject in need a therapeutically effective amount of one or more of the compounds of Formulae (I-III) or a pharmaceutically acceptable salt, prodrug, solvate, hydrate, or stereoisomer thereof, or compositions of these, wherein X, Y, Z, J, M, and R1 to R8 are defined herein, these compounds and methods are effective in treating conditions associated with dysregulation of the RAS/RAF/MEK/ERK pathway or which are treatable by inhibiting Erk 1/2. A variety of conditions can be treated using these compounds and methods and include diseases which are characterized by abnormal cellular proliferation. In one embodiment, the disease is cancer.

Abstract: Embodiments of the disclosure relate generally to formulations, methods, kits, and dosage forms for improved stability of an active pharmaceutical ingredient, wherein the active ingredient comprises a compound of the formula: wherein X is N, Y is H or optionally substituted C1-C6 alkyl; R4 is morpholine optionally substituted with by C1-C6 alkyl; R7 is C1-C6 alkyl optionally substituted by one or more F; R8? is halogen; and R6 is wherein R10 is H, C1-C6 alkyl, halogen, CN or CF3; R12 is H or halogen; R13 is H, halogen or C1-C6 alkyl; and R17 is H, C1-C6 alkyl, (C1-C6 alkyl)-NH2; and, pharmaceutically acceptable salts and free bases thereof, wherein the active ingredient remains in substantially amorphous form after storage of the pharmaceutical formulation for a predetermined time and conditions.

Abstract: Embodiments of the disclosure relate generally to formulations, methods, kits, and dosage forms for improved stability of an active pharmaceutical ingredient, wherein the active ingredient comprises a compound of the formula: wherein X is N, Y is H or optionally substituted C1-C6 alkyl; R4 is morpholine optionally substituted with by C1-C6 alkyl; R7 is C1-C6 alkyl optionally substituted by one or more F; R8? is halogen; and R6 is wherein R10 is H, C1-C6 alkyl, halogen, CN or CF3; R12 is H or halogen; R13 is H, halogen or C1-C6 alkyl; and R17 is H, C1-C6 alkyl, (C1-C6 alkyl)-NH2; and, pharmaceutically acceptable salts and free bases thereof, wherein the active ingredient remains in substantially amorphous form after storage of the pharmaceutical formulation for a predetermined time and conditions.

Abstract: Embodiments of the disclosure relate generally to formulations, methods of treatment, kits, and dosage forms for treating inflammatory disorders, including atopic dermatitis, or cancer, the formulations comprising an active pharmaceutical ingredient. The formulation provided comprises granules, wherein the granules comprise: micronized active ingredient; one or more granulation binders; one or more fillers; one or more disintegrants; and one or more antioxidants. In one embodiment, the methods of treatment include orally administering the active ingredient to a subject suffering from atopic dermatitis, where the active ingredient is in an amount of about 20 mg to about 80 mg.