The present invention relates to a controlled release formulation comprising the active compounds tesofensine and a beta blocker, such as metoprolol or carvedilol, or a pharmaceutically acceptable salt thereof. The invention further relates to use of the controlled release formulation in a method of treatment of diabetes, obesity, or an obesity associated disorder.

Disclosed herein are pharmaceutical salts of a cationic protonated polyamine pharmaceutical agent and an anionic organic carboxylate which is hydrophobic when in protonated form, particularly suited for oral administration, where these salts have good bioavailability in solid dosage forms and may be used in the treatment of cancer and other medical conditions for which the pharmaceutical agent is intended.

Provided is a solid preparation comprising a controlled-release film, wherein the controlled-release film includes a dry film of an edible ink, and contains a water-insoluble polymer, and has excellent controlled-releasability of an active ingredient contained in a tablet core. The solid preparation according to the present invention comprises a tablet core, and at least one layer of a controlled-release film provided on at least a part of a surface of the tablet core, wherein the tablet core contains at least one active ingredient, and the controlled-release film includes a dry film of an edible ink containing at least one water insoluble polymer.

A unit dosage of an oral composition of an extract of Withania somnifera is disclosed. The extract of Withania somnifera includes total withanolides. The total withanolides includes withanolide glycosides and withanolide aglycones. The extract of Withania somnifera includes about 32% to about 38% by weight of the withanolide glycosides. Methods of preparing the extract of Withania somnifera are disclosed. Methods of treatment by administering the extract of Withania somnifera are disclosed.

Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

The present invention relates to pharmaceutical oral dosage forms releasing compounds in specific parts of the small intestine of a subject, wherein said compounds stimulate enteroendocrine cells in the subject's jejunum and lower small intestine to release one or more enterokines. The present invention also relates to a method of producing such pharmaceutical oral dosage forms. The pharmaceutical oral dosage forms of the invention are particularly for use in the treatment and prevention of metabolic conditions or diseases, osteoporosis, malabsorption conditions, neurodegenerative diseases, conditions of impaired gastro-intestinal function and cardiovascular diseases.

Pharmaceutical compositions are described comprising (a) dimethyl fumarate, (b) a diluent selected from monosaccharides, disaccharides, starch and starch derivatives, calcium and magnesium inorganic salts, sugar alcohols, and mixtures thereof, (c) microcrystalline cellulose and (d) croscarmellose sodium, wherein the dimethyl fumarate is not covered with a gastroresistant coating. These compositions are intended for the treatment of some inflammatory autoimmune diseases or disorders.

Herein described are solid oral compositions of dyes for use in diagnostic endoscopy, preferably colon endoscopy.

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.

There is provided herein a pharmaceutical formulation having one or more component comprising valproic acid (VPA) and/or a pharmaceutically acceptable salt thereof; and one or more secondary acid, and optionally comprising one or more pharmaceutically acceptable excipient. There is also provided uses of such formulations.