An oral dosage form of an antidiabetic pharmaceutical composition comprises a core portion, an outer portion, and a controlled membrane film sandwiched therebetween. The core and outer portions respectively comprise a first antidiabetic agent and a second antidiabetic agent, such as metformin HCl and sitagliptin phosphate, each at a therapeutically effective amount. The controlled membrane film encapsulates the core portion and is provided with at least one passageway for allowing the first antidiabetic agent to release out when the oral dosage form is in an aqueous environment, such as in the gastrointestinal (GI) tract of a subject. The oral dosage form is configured, upon a single-dose oral administration, to provide a maximum plasma concentration of the first antidiabetic agent in the subject from approximately 7.5 to 15 hours after administration. A method for manufacturing the oral dosage form of the antidiabetic pharmaceutical composition is also provided.

Methods and formulations of reducing one or more symptoms of gastroesophageal reflux disease (GERD) in a human patient with symptomatic GERD not completely responsive to proton pump inhibitors (PPIs). The patient is administered a therapeutically effective amount of an enteric coated gastro-retentive oral dosage form in the form of a tablet of a bile acid sequestrant dispersed in a polymeric matrix consisting essentially of poly(alkylene)oxide and one or more filler or compressing agent such that the patient experiences a clinically meaningful reduction in one or more symptoms of GERD.

The disclosure describes an injection molding process for coating a tablet core to produce a coated pharmaceutical tablet, wherein the injection-molded coating is substantially continuous (e.g., completely covers the tablet core with no openings), and describes the resulting coated pharmaceutical tablet. The disclosure describes compositions for coatings and tablet cores and equipment suitable for performing the process.

Provided are a film coating composition containing a PVA having a degree of hydrolysis of 85.0 to 89.0 mol %, characterized in that even when the composition is used for coating of tablets without any additives other than PVAs, the tablets do not tend to stick to each other; a solid oral formulation using the composition; and a method for producing the same.

The present invention discloses a novel film coating composition of polyvinyl alcohol (PVA) in combination with sugar, and a plasticizer or a combination of plasticizers resulting in a composition which is non tacky and easily dispersible in water at high solids content. The coating compositions help in achieving higher spray rates, disperse in less solvent i.e water, and helps in reduction of coating process time. Further the resultant film which when coated onto substrates exhibits good adhesion and provides smooth surface to substrates.

A new process for making ivabradine hydrochloride drug product reduces the amount of amorphous ivabradine hydrochloride in the drug product.

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The present invention describes a pharmaceutical and/or nutritional composition comprising methylfolate in the form of granules, together with a carnitine derivative salt, pharmaceutically acceptable excipients, and optionally other pharmaceutical or nutraceutical active ingredients. The composition is useful for oral administration. The invention also relates to the process for obtaining the composition comprising methylfolate in the form of granules and the use thereof for the treatment of disorders associated with a reduction of methylfolate, wherein methylfolate is useful.

The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment (including treatment of rheumatoid arthritis and various spondyloarthritic conditions, including types of axial spondyloarthritis (axSpA)), kits, methods of synthesis, and products-by-process. In various aspects, provided are methods for treating active non-radiographic axSpA (nr-axSpA) and methods for treating active ankylosing spondylitis (AS).

An oral amphetamine extended release solid dose is described. The compositions contain a combination of an uncoated amphetamine-cation exchange resin complex, a barrier coated amphetamine-cation exchange resin complex-matrix, and an uncomplexed amphetamine, wherein one or more of these components contains blends of different forms of amphetamines. Either the modified release coated and/or the uncoated amphetamine-cation exchange resin complex may have two forms of amphetamine in a complex with a single cation exchange resin. Following administration of a single dose of the composition, a therapeutically effective amount of amphetamine is reached by about one hour and the composition provides at least a thirteen hour effect post-dose.

The present invention relates to solid dispersions including, but not limited to, co-processed carbohydrates with different solubilities and concentrations, which have a microcrystalline plate structure. The solid dispersions, excipient systems and formulations of the present invention are highly compactable and durable and when compressed into solid dosage forms demonstrate uniform densification, low friability at low pressures, and and/or relatively constant low disintegration times at various hardnesses. The solid dosage forms of the present invention demonstrate superior organoleptics, disintegration, and/or robustness.