The invention relates to modified release oral formulations of therapeutic agents, including gamma hydroxybutyrate (GHB), paracetamol, codeine or oxycodone, which are resistant to alcohol induced dose dumping. Provided are formulations that have improved resistance to rapid release of the active ingredient in the presence of increasing amounts of alcohol. Also provided are formulations that can reduce or prevent the release of the active ingredient following exposure to alcohol-containing media. The invention also relates to methods of making the formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.

Disclosed is a method of manufacturing a cardiovascular fixed-dose combination pharmaceutical dosage form that includes an anti-hypertensive active agent, a cholesterol-lowering active agent, and optionally, an enteric-coated aspirin or platelet inhibitor. The fixed-dose combination is prepared with at least two granulation solutions that are free of citric acid and enhance the aqueous solubility of the cholesterol-lowering agent in fixed-dose combination. The active agents in the resulting dosage form, which is also free of citric acid, have the same strength and release profiles as the same active agents prepared as a single formulation.

An object of the present invention is to provide a film coated tablet that has an excellent tablet slipperiness in an oral cavity and prevents delay in disintegration time of an uncoated tablet. The present invention provides a film coated tablet including a tablet, a first film layer that coats the tablet and contains an inorganic salt, and a second film layer that coats the tablet coated with the first film layer and contains a thickener, and a film coated tablet including a tablet, a first film layer that coats the tablet, and a second film layer that coats an outside of the first film layer and contains a thickener, in which the first film layer contains an inorganic salt, and the inorganic salt reduces a viscosity of the thickener contained in the second film layer

The present invention relates to oral controlled-release formulations of 5-(pyridinyl)-2(1H)-pyridinone compounds and their use in the treatment of a subject with heart failure, a stage, class or manifestation of heart failure, or at risk of developing or exhibiting symptoms of heart failure. The formulations of the invention release the compounds in the range of between 0.1 μg/kg body weight/minute and 20 μg/kg body weight/minute.

Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

An oral dosage form of ticagrelor includes a core and a semi-permeable membrane coating the core. The core comprises a first drug layer and a push layer. The first drug layer contains ticagrelor that is sufficient to deliver an effective amount of the drug over an intended delivery time. The push layer comprises a swelling agent and an osmogen agent. The semi-permeable membrane has at least one passageway formed therethrough, positionally configured to face the first drug layer, but not to face the push layer, of the core, and functionally configured to allow the ticagrelor to realize an extended release out of the core upon contacting an aqueous environment. The dosage form optionally further includes a second ticagrelor-containing drug layer coating the semi-permeable membrane, thereby providing a starting effective dose upon administration. The dosage form can realize once-a-day administration of ticagrelor of patients in need thereof.

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.

This invention relates to dosage forms comprising pseudoephedrine or a salt thereof, for extended-release up to 24 hours, and process of making such dosage forms. This invention provides a non-osmotic extended-release dosage form comprising pseudoephedrine hydrochloride which can be administered to patients who need and/or desire a decongestant medication up to 24 hours. This invention also relates to dosage forms comprising pseudoephedrine or a salt thereof and cetirizine or levocetirizine or its salts thereof for extended-release up to 24 hours, and process of making such dosage forms.

The present invention provides a simple and improved dosage form that is capable of providing a controlled release of GABA.sub.B receptor agonist contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to GABA.sub.B receptor agonist.

The invention relates to a solid, pharmaceutical composition in compressed tablet form. The tablet comprises an ibuprofen core tablet, a pair of protective barriers and a famotidine outermost coating. The ibuprofen core tablet comprises ibuprofen and one or more pharmaceutically acceptable excipients selected from disintegrants, diluents, fillers, binders, glidants and lubricants. The pair of protective barrier coatings surround the ibuprofen core tablet. The first coating comprises a methacrylic acid and ethyl acrylate copolymer, a surfactant, and hydroxypropylmethylcellulose. The second coating comprises hydroxypropylmethylcellulose, and a plasticizer. The outermost coating comprises famotidine, polyvinyl alcohol and a plasticizer.