Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced C.sub.max, a C.sub.min:C.sub.max ratio of ≥0.4, Fluctuation Index of ≤1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.

A material comprising a highly branched carbohydrate polymer, a polyalkylene glycol (or polyalkylene oxide) linked to the highly branched carbohydrate polymer, and a hydrophobic or amphiphilic group linked to the highly branched carbohydrate polymer and/or the polyalkylene glycol (or polyalkylene oxide), is described. Methods of making and using the material, as well as a soluble composition that contains the material and a hydrophobic solute compound, are also described.

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 invention relates to cannabinoid and/or nicotine loaded granules, consisting of orodispersible sugar granules loaded with at least one cannabinoid compound and/or nicotine.

Oral pharmaceutical compositions of sodium oxybate having improved pharmacokinetic properties when administered less than two hours after eating are provided, and therapeutic uses thereof.

Compositions for the immediate release of one or more cannabinoids, in which the compositions comprise a population of particles. Each particle may comprise the one or more cannabinoids and one or more intra-granule excipients. Alternatively, each particle may comprise the one or more cannabinoids and a porous bead core. The composition may be prepared by a method that involves combining the one or more cannabinoids with the one or more intra-granule excipients, and then granulating the combination, such as through fluid bed granulation, shear-induced wet granulation, or spray granulation. The composition may also be prepared by a method that involves mixing the one or more cannabinoids with a population of porous bead cores.

Provided herein are dietary supplement compositions comprising a plurality of beadlets and an oil. Provided herein are also dietary supplement compositions comprising a plurality of mini-tabs and oil. The beadlets or mini-tabs comprise at least one nutrient that is miscible in aqueous solution, and the oil comprises at least one fat-soluble nutrient. The composition may be contained within one or more capsules, and be packaged with a scented insert.

A variety of nanoparticles or microparticles may be used to treat diseases such as restenosis or blood clots. For example, a nanoparticle or microparticle may include a core having a biodegradable polymer, an exterior having hydrophilic moieties. and a therapeutic agent. The nanoparticles may include targeting moieties that target the nanoparticle or microparticle to an arterial lesion. The nanoparticle or microparticle may include an exterior shell around the core to increase stability of the nanoparticle or microparticle. The nanoparticle or microparticle may include a magnetic particle to allow targeted delivery of the nanoparticle or microparticle via a magnetic field. The nanoparticles or microparticles may be coated on a medical device, such as a catheter balloon or a stent, or may be delivered systemically or locally to patients in need thereof.

The present disclosure relates to modified release formulations of 2-methyl-2-(3-methyl-4-(4-(methylamino)-5-(trifluoromethyl)pyrimidin-2-ylamino)-IH-pyrazol-1-propanenitrile or solvates, tautomers, and pharmaceutically acceptable salts thereof, and methods of treatment with the modified release formulations.