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).

The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

The instant invention relates to new film-forming compositions based on starchy material, comprising isosorbide. The instant invention also relates to products made from the film-forming compositions of the invention, in particular hard and soft capsules shells, and to methods for the manufacture of such products.

α-amino boronic acid derivatives are useful for inhibiting the activity of immunoproteasome (LMP7) and for the treatment and/or prevention of medical conditions affected by immunoproteasome activity such as inflammatory and autoimmune diseases, neurodegenerative diseases, proliferative diseases and cancer.

Pharmaceutical formulation dosage form (1) with a core (2) encapsulated by at least one shell (3) and comprising at least one active pharmaceutical ingredient (4), wherein the at least one active pharmaceutical ingredient (4) is embedded in said core (2) of the pharmaceutical formulation dosage form (1), preferably in that said core (2) is formed by a matrix based on xyloglucan (5) containing said active pharmaceutical ingredient (4), and wherein said shell (3) is a pH-responsive coating.

A method of preserving the one or more chemical and/or biological species in a polymer matrix comprising pullulan and trehalose is described. The method includes combining the one or more chemical and/or biological species, an aqueous pullulan and a trehalose solution and drying the resultant mixture to provide a solid polymeric matrix. A polymeric matrix comprising one or more chemical and/or biological species and its use, for example, on surfaces for food preparation, for food preservation and in biological preparations is also described.

Provided herein are pharmaceutical packages that include a pharmaceutical tablet or capsule, and a volatile medication adherence marker (MAM) contained on or in a MAM reservoir external to the pharmaceutical tablet or capsule. Also provided herein are methods of surface coating a pharmaceutical tablet or capsule with a volatile medication adherence marker (MAM) that include placing the pharmaceutical tablet or capsule in a sealed container with the volatile MAM contained on or in a MAM reservoir external to the pharmaceutical tablet or capsule, and maintaining the seal of the container for a sufficient time to allow MAM vapors from the volatile MAM reservoir to adsorb to onto a surface of the pharmaceutical tablet or capsule. Also provided are methods of medication adherence monitoring using such pharmaceutical tablets or capsules.

Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

The present disclosure is directed to compositions of materials and methods of making those compositions. These compositions include cellulose materials that may be consumed by an animal without chewing. Compositions of the present disclosure may also include coatings that resist dissolution in the mouth of an animal, yet readily dissolve in the digestive tract of an animal or human/person. The present disclosure is also directed to administering selected compositions to treat specific ailments or conditions that may affect animals or humans. Such treatments include treating conditions related to improving gut health, reducing neuro-inflammation, and treating metabolic diseases. Additionally, such treatments include the stimulation, enhancement and/or compatibility with microbiota and the effects of microbiota on diseases and conditions, such as gut health of an animal, including a human.