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: Properties of a medium, such as its particle size distribution, are characterized using a measurement cell containing a medium between walls of the cell, with ultrasound transducers on opposite walls. Ultrasound is transmitted from the ultrasound transducers on both sides and transmission and reflection responses are detected. An ultrasound frequency dependent ratio of a Fourier transform value of a product of signals obtained from transmission responses in opposite directions and a Fourier transform value of a product of signals obtained from reflections at the transducers is computed. Preferably, the first received reflected and transmitted pulses in response to pulse excitation are used to compute the ratio. Ultrasound frequency dependent ultrasound speed and/or attenuation data of ultrasound in the medium are computed as a function of the ultrasound frequency from the ratio. This eliminates the effect of the walls.

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.

Abstract: Properties of a medium, such as its particle size distribution, are characterized using a measurement cell containing a medium between walls of the cell, with ultrasound transducers on opposite walls. Ultrasound is transmitted from the ultrasound transducers on both sides and transmission and reflection responses are detected. An ultrasound frequency dependent ratio of a Fourier transform value of a product of signals obtained from transmission responses in opposite directions and a Fourier transform value of a product of signals obtained from reflections at the transducers is computed. Preferably, the first received reflected and transmitted pulses in response to pulse excitation are used to compute the ratio. Ultrasound frequency dependent ultrasound speed and/or attenuation data of ultrasound in the medium are computed as a function of the ultrasound frequency from the ratio. This eliminates the effect of the walls.

Abstract: The present invention relates to a method of treating patients suffering from cancers driven by deregulated Human Epidermal Growth Factor Receptor (HER/Human EGFR), wherein an irreversible tyrosine kinase inhibitor (TKI) is administered according to a continuous regimen based on an average daily dose in the range of 10 to 50 mg and the mAB is co-administered according to a dosing regimen ranging from an average weekly iv dose of 50 to 500 mg/m2 repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least monthly to a patient in need of such treatment.

Abstract: The present invention relates to a method of treating patients suffering from cancers driven by deregulated Human Epidermal Growth Factor Receptor (HER/Human EGFR), wherein an irreversible tyrosine kinase inhibitor (TKI) is administered according to a continuous regimen based on an average daily dose in the range of 10 to 50 mg and the mAB is co-administered according to a dosing regimen ranging from an average weekly iv dose of 50 to 500 mg/m2 repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least monthly to a patient in need of such treatment.

Abstract: The present invention relates to a method of treating patients suffering from cancers driven by deregulated Human Epidermal Growth Factor Receptor (HER/Human EGFR), wherein an irreversible tyrosine kinase inhibitor (TKI) is administered according to a continuous regimen based on an average daily dose in the range of 10 to 50 mg and the mAB is co-administered according to a dosing regimen ranging from an average weekly iv dose of 50 to 500 mg/m2 repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least monthly to a patient in need of such treatment.

Abstract: The present invention relates to a method of treating patients suffering from cancers driven by deregulated Human Epidermal Growth Factor Receptor (HER/Human EGFR), wherein an irreversible tyrosine kinase inhibitor (TKI) is administered according to a continuous regimen based on an average daily dose in the range of 10 to 50 mg and the mAB is co-administered according to a dosing regimen ranging from an average weekly iv dose of 50 to 500 mg/m2 repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least monthly to a patient in need of such treatment.

Abstract: The present Invention relates to a method of treating abnormal cell growth in a subject, comprising administering to said subject having abnormal cell growth: (a) a compound selected from the group consisting of a camptothecin, a camptothecin derivative, or a pharmaceutically acceptable salt, solvate or prodrug of said compounds; (b) a pyrimidine derivative or a pharmaceutically acceptable salt, solvate or prodrug of said pyrimidine derivative; and (c) an anti-tumor agent selected from the group consisting of antiproliferative agents, kinase inhibitors, angiogenesis inhibitors, growth factor inhibitors, cox-I inhibitors, cox-II inhibitors, mitotic inhibitors, alkylating agents, anti-metabolites, intercalating antibiotics, growth factor inhibitors, radiation, cell cycle inhibitors, enzymes, topoisomerase inhibitors, biological response modifiers, antibodies, cytotoxics, anti-hormones, anti-androgens and combinations thereof.

Abstract: Therapeutic pharmaceutical compositions and methods of treatment of abnormal cell growth comprising a pyrimidine derivative or a pharmaceutically acceptable salt, solvate or prodrug thereof in combination with an oral camptothecin, an oral camptothecin derivative, an indolopyrrocarbazole derivative or a pharmaceutically acceptable salt, solvate or prodrug thereof for the treatment of cancer are described. In one embodiment of the present invention the oral camptothecin derivative is selected from the group consisting of 10-hydroxycamptothecin, 9-aminocamptothecin, 9-nitrocamptothecin, irinotecan, irinotecan salt, SN-38, CPT-11, and topotecan and the indolopyrrocarbazole derivative is edotecarin. In one embodiment the pyrimidine derivative is selected from the group consisting gemcitabine, MTA and capecitabine. In one preferred embodiment, the pyrimidine derivative is capecitabine and the camptothecin derivative is CPT-11.

Abstract: This invention relates to a method of treatment of cancer with a combination of an erbB2 ligand and an antibody, in mammals. More particularly, this invention relates to a method of treating cancer by administering an erbB2 ligand in combination with an erbB antibody. This invention also relates to a kit useful in the treatment of abnormal cell growth in mammals, especially humans.