A pharmaceutical composition useful for the treatment of multiple myeloma in combination with an anti-cancer drug is provided. The pharmaceutical composition includes high-dose dexamethasone or a pharmaceutically acceptable salt or solvate thereof.

A method for manufacturing an orally disintegrating tablet, in which adequate hardness for preventing breakage of the tablet during transport or handling by a medical practitioner or a patient is provided while rapid disintegration is maintained. The method for manufacturing an orally disintegrating tablet according to an embodiment of the present invention comprises spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa.Math.s or more and 400 mPa.Math.s on additives, and performing fluid bed granulation. The liquid including hydroxypropyl cellulose may be sprayed or dropped on the additives so that the content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % to 5 wt %.

Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

The present invention relates to an enteric coating tablet comprising: a core containing, as an active ingredient, dimethyl fumarate or a pharmaceutically acceptable salt thereof; and an enteric coating layer, and provides a tablet, which exhibits an effect equal to that of a capsule dosage form currently on the market, can be prepared through a simple preparation process, and is a dosage form having excellent storage stability and administration convenience, and thus can be applied to various patient groups.

The present invention relates to the field of pharmacy, particularly to a pharmaceutical composition for oral administration comprising an (a) inert substrate and a (b) mixture comprising a non-bile acid farnesoid X receptor (FXR) agonist, such as 2-[(1R,3r,5S)-3-({5-cyclopropyl-3-[2-(trifluoromethoxy)phenyl]-1,2-oxazol-4-yl}methoxy)-8-azabicyclo[3.2.1]octan-8-yl]-4-fluoro-1,3-benzothiazole-6-carboxylic acid, or a pharmaceutically acceptable salt thereof, and at least one binder. The present invention also relates to a process for preparing said pharmaceutical composition for oral administration; and to the use of said pharmaceutical composition in the manufacture of a medicament.

Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the Lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

The present invention disclosed herein provides synergistic nutritional neuroprotective compositions for ameliorating neural dysfunction. Particularly, the invention relates to synergistic, efficient, nutritional composition for comprising specific combination of decarboxylated L-arginine called agmatine sulphate and nicotinamide riboside chloride, wherein agmatine sulphate and nicotinamide riboside chloride are present in the weight ratio of 1:0.05 to 1:2 along with pharmaceutically acceptable excipients. More particularly, the present invention offers synergistic effect for ameliorating neural dysfunction encompasses cerebrovascular diseases, neurodevelopmental disorders, mood disorders, mental health disorders and like thereof.

Described are sustained-release solid dosage forms of epigallocatechin gallate (EGCG) or aminosterol compositions. In one aspect of the invention the sustained-release solid dosage forms of EGCG or an aminosterol are capsules comprising a plurality of coated solid particulates. Another aspect of the invention relates to methods of inhibiting, ameliorating, reducing the likelihood of, delaying the onset of, treating or preventing an amyloid disorder, comprising the step of administering to a subject in need a therapeutically effective amount of the solid dosage form. In certain aspects, the amyloid disorder is Parkinson's Disease.

The invention relates to oral analgesic compositions for alleviation of perceived nicotine irritation through inhibition or blocking of nicotine activated receptors or ion channels in the gastrointestinal tract, including the oral cavity. The composition of the invention comprises one or more nicotine sources, one or more buffering agents, and at least two antagonists in an effective amount to inhibit or block nicotine agonist activation of Nicotinic Acetylcholine Receptors (nAChR) and/or Transient Receptor Potential (TRP) ion channels, the at least two antagonists being selected from the group consisting of a first antagonist comprising camphor or one or more compounds resembling camphor, a second antagonist comprising eucalyptol, and a third antagonist comprising (1R,2S,5R)—N-(4-Methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide (WS-12).

The disclosure relates to a pressurized Metered Dose Inhaler-compatible tablet, i.e. one that is able to be dispersed or disintegrates within a liquid phase propellant, which is used in a pressurized Metered Dose Inhaler formulation containing at least one active pharmaceutical ingredient and one or more excipients.