Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention are in the form of a bead and comprise (i) an inert core; (ii) a first layer surrounding the inert core, wherein the first layer comprises dimethyl fumarate; and (iii) an enteric coating surrounding the first layer. Also provided are pharmaceutical compositions in the form of a bead comprising a core and an enteric coating surrounding the core, wherein the core comprises dimethyl fumarate. Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention comprises a first pharmaceutical bead composition and a second pharmaceutical bead composition, wherein the first pharmaceutical bead composition is an enterically coated immediate-release composition and the second pharmaceutical bead composition is an enterically coated controlled-release composition, wherein the first pharmaceutical bead composition and the second pharmaceutical bead composition both comprise dimethyl fumarate Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and an polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23 to 1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

Some embodiments of the present application are directed to oral formulations of L-ornithine phenylacetate and methods of using the same. These oral formulations offer alternative administration route than the standard intravenous administration of L-ornithine phenylacetate for treating hyperammonemia in patients having various acute and chronic liver diseases and disorders, for example, acute liver failure, liver cirrhosis, liver decompensation, portal hypertension, hepatic encephalopathy, or patients with urea cycle disorders.

Provided herein are the extended release pharmaceutical composition suitable for once or twice daily dosing comprising riociguat and at least one or more pharmaceutically acceptable excipients. The present invention also relates to method for preparing extended release composition and method of using these dosage forms for the treatment of pulmonary hypertension and related diseases. The present invention provides extended release composition of riociguat which are expected to exhibit desired technical attributes such as assay, stability and release profile suitable for once or twice daily administration.

The present invention relates to crystal modifications of 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N—{(R)-α-[N—((S)-1-carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepine (odevixibat), more specifically crystal modifications 1 and 2 of odevixibat. The invention also relates to a process for the preparation of crystal modification 1 of odevixibat, to a pharmaceutical composition comprising crystal modification 1, and to the use of this crystal modification in the treatment of various conditions as described herein.

The present invention relates to the localized delivery of nucleic acids to cells using polyelectrolyte assemblies in the form of particles that are prepared by layer-by-layer deposition of nucleic acid and specific polycation. It also relates to compositions comprising said particles and methods for the treatment of disorders or diseases by administration of such particles.

This disclosure provides pharmaceutical compositions comprising midodrine, a pharmaceutically acceptable salt thereof, desglymidodrine, a pharmaceutically acceptable salt thereof, or a combination therefore that can be administered to a human subject in need thereof in a supine position. The disclosure also provides pharmaceutical compositions which can be administered once-a-day. This disclosure further provides pharmaceutical compositions comprising an extended release composition and providing a delayed release period between about 30 min to about 12 hours.