Disclosed are pharmaceutical compositions comprising Compound I, having the formula: ##STR00001##
and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

The present invention relates to methods for treating uremic pruritus with anti-pruritic compositions, wherein the method provides a therapeutic effect in a patient.

Aspects of the present invention are directed to an oral dosage form comprising a core containing one more active ingredients and a fast-release exterior coating. The fast release exterior coating includes a water soluble polymer; a saccharide or sugar alcohol, or a combination thereof, and a flavoring. The flavoring may be a warming sensate that is released in the oral cavity of the user after inserting the dosage form in his or her mouth.

A composition for reducing damage associated with oxidative phosphorylation. The composition comprises an upregulating compound mixture configured to upregulate an endogenous antioxidant system, an exogenous antioxidant mixture configured to inhibit oxidation of biomolecules by reactive oxygen species, and a mineral mixture configured to provide one or more cofactors to a endogenous antioxidant enzyme. The endogenous antioxidant system includes a Nrf2 transcription factors that promotes transcription of antioxidant genes.

The present invention relates to a pharmaceutical composition including (i) as a major ingredient, a novel 5-{4-(Aminosulfonyl)phenyl}-2,2-dimethyl-4-(3-fluorophenyl)-3(2H)-furanone compound (Formula 1) or a pharmaceutically acceptable salt thereof, which has a crystalline form A or G, or a mixed form thereof and has a 50% volume particle diameter (d.sub.(0.5)) of 3 μm to 9 μm and a 90% volume particle diameter (d.sub.(0.9)) of 10 μm to 50 μm, (ii) a pharmaceutically acceptable diluent, and (iii) a pharmaceutically acceptable lubricant. The pharmaceutical composition of the present invention has the advantages of good stability, high dissolution rate, improved content uniformity, and excellent pharmacokinetic properties. Due to these advantages, as a non-steroidal anti-inflammatory drug, the pharmaceutical composition of the present invention may be effective in treating inflammation or pain.

The present disclosure relates to a process for preparing arimoclomol, arimoclomol citrate and key intermediates, such as ORZY-01, thereof. The disclosure further relates to a process for preparing high purity arimoclomol citrate and methods of using the same.

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate - ion exchange resin complex, a barrier coated methylphenidate - ion exchange resin complex -matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

The present invention concerns pharmaceutical formulations of ARN-509, which can be administered to a mammal, in particular a human, suffering from an androgen receptor (AR)-related disease or condition, in particular cancer, more in particular prostate cancer, including but not limited to castration-resistant prostate cancer, metastatic castration resistant prostate cancer, chemotherapy-naïve metastatic castration resistant prostate cancer, biochemically relapsed hormone sensitive prostate cancer, or high-risk, non-metastatic castration-resistant prostate cancer. In one aspect, these formulations comprise a solid dispersion of ARN-509 and HPMCAS. In one aspect, the solid dispersion of ARN-509 and HPMCAS is obtainable, in particular is obtained, by melt-extruding a mixture comprising ARN-509 and HPMCAS and optionally subsequently milling said melt-extruded mixture. In one aspect, the solid dispersion of ARN-509 and HPMCAS is obtainable, in particular is obtained, by spray drying a mixture comprising ARN-509 and HPMCAS in a suitable solvent.

Compositions and methods for improving nitric oxide levels in a subject, comprising administering to a subject, a composition comprising dietary nitrate derived from potassium nitrate, beet root (whole plant, powder, plant extract), and/or nitrate-rich leafy green portions (whole plant, powder, plant extract) that improve functional nitric oxide levels in subjects as shown by increasing salivary bioconversion of nitrate to nitrite, a necessary a required step for nitric oxide mediated health benefits. The disclosed novel compositions improve cardiac health, lowers blood pressure, intraocular pressure, and LDL and restores nitric oxide mediated cardiovascular benefits, including but not limited, restoring endothelium function and improving flow mediated dilation.

There is provided a convenient new treatment of Parkinson disease by a frequent administration of optimal levodopa doses mimicking a continuous intravenous or infusion treatment, thus mitigating motor complications; and a new carbidopa/levodopa pharmaceutical unit form providing said new treatment.