Described herein are formulations of a somatostatin modulator, methods of making such formulations, and methods of using such formulations in the treatment of conditions, diseases, or disorders that would benefit from modulation of somatostatin activity.

There are provided a granulated product (GP) including at least one selected from an active ingredient, an excipient and a disintegrant, and 0.1 to 5.0% by mass, based on mass of the GP, of a polyvinyl alcohol having a saponification degree of from 60 to 77 mol %; a solid preparation including the GP; and an active ingredient in case where the GP does not contain the active ingredient; and a method for producing a GP, including a granulation step of granulating, while adding a second component including at least water, a first component including at least one selected from an active ingredient, an excipient and a disintegrant to obtain the GP, wherein the first component and/or the second component includes a polyvinyl alcohol having a saponification degree of 60 to 77 mol % in an amount of from 0.1 to 5.0% by mass, based on mass of the GP.

One of the objects of the present invention is to provide a granule capable of sufficiently masking bitterness. Alternatively, one of the objects of the present invention is to provide a preparation containing a granule capable of sufficiently masking bitterness. According to an embodiment of the present invention, a granule is provided including a core substance on which a melt component and an active ingredient are disposed, a gelling substance-containing layer disposed on a surface where the melt component and the active ingredient are disposed, and a hydrophobic polymer-containing layer disposed on a surface of the gelling substance-containing layer.

Described herein are therapeutic beverages that include a beverage type liquid medium and a plurality of spherical- and/or spheroidal-shaped particles dispersed within the liquid medium, wherein the plurality of the spherical- and/or spheroidal-shaped particles comprise at least one active pharmaceutical ingredient (API) disposed within the plurality of the spherical- and/or spheroidal-shaped particles. Also, described herein are methods of producing the described therapeutic beverages.

The present invention relates to a pharmaceutical composition of 8-chloro-5-methyl-1-[4-(2-pyridyloxy)cyclohexyl]-4,6-dihydro-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine, a process for the preparation thereof and its use in the treatment of diseases.

Methods are provided for promoting the adsorption of an active agent to microparticles by modifying the structural properties of the active agent in order to facilitate favorable association to the microparticle.

The invention relates to modified release granular composition comprising melatonin and at least one non-swelling release controlling agent. The matrix granular composition as described herein may be specifically comprised of about 1 to 70% by weight of melatonin and about 10 to 70% by weight of non-swelling release controlling agent along with at least one excipient. The invention also relates to a process for preparation, wherein melatonin is uniformly embedded in at least one non-swelling release controlling agent using controlled heat conditions and the matrix granules may be optionally treated with non-swelling polymeric granulating agent to obtain modified release composition. The composition as described herein exhibits about 80% release of melatonin over 6-10 hours. The taste-masked granules can be formulated in suitable oral dosage forms which can be conveniently administered for improvement in quality of sleep to the subjects in need thereof.

Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

An oral solid formulation includes irinotecan or a pharmaceutically acceptable salt thereof as an active ingredient, and an acidifying agent. A method of preparing an oral solid formulation includes forming granules containing irinotecan or a pharmaceutically acceptable salt thereof, a diluent, and a binder, mixing the granules with a disintegrant and a lubricant to obtain a mixture, and includes adding an acidifying agent in step of forming granules and/or mixing the granules.

An aqueous alkaline composition comprising a cannabinoid which may be cannabidiol (CBD) used alone or in combination with other cannabinoids. An alkalizing agent which comprises pico size carbon particles is present in the composition, in an amount suitable for buffering the composition to a pH between about 7.5 and 9.5. The aqueous alkaline composition is stable and may be used in the preparation of a beverage or a pharmaceutical composition.