The present disclosure provides chewable tablets comprising (i) a compressed core including a bioactive molecule; (ii) a protective layer over said compressed core, and (iii) one or more soft-coating layers over said protective layer, each soft coating layer comprises gum base powder; wherein the protective layer comprises water-insoluble cellulose based polymers, preferably ethyl cellulose based polymer.

Compounds of formula (I), wherein A, R, W, Q, L, n and m have the meaning according to the claims, can be employed, inter alia, for the treatment of tauopathies and Alzheimer's disease. ##STR00001##

The present disclosure provides a method for the treatment of Parkinson's disease comprising simultaneously or sequentially administering to a patient in need of treatment of Parkinson's disease a dosage form comprising (i) levodopa in an amount ranging from 50 mg to 300 mg, (ii) carbidopa in an amount ranging from 25 mg to 150 mg or a therapeutically equivalent amount of another aromatic amino acid decarboxylase inhibitor, and (iii) entacapone in an amount ranging from 50 mg to 300 mg, wherein the proportion of entacapone to carbidopa in said dosage form ranges from 0.3:1.0 to 3.2:1.0 by weight, a moderately potent COMT inhibitor in an amount ranging from 25 mg to 200 mg, wherein the proportion of said COMT inhibitor to carbidopa in said dosage form ranges from 0.16:1.0 to 3.08:1.0 by weight, or a highly potent COMT inhibitor in an amount ranging from 1 mg to 100 mg, wherein the proportion of said COMT inhibitor to carbidopa in said dosage form ranges from 0.006:1.0 to 1.54:1.0 by weight. Pharmaceutical dosage form used in said method are also disclosed.

The gut-brain axis, neurobiology and neurotransmission are physiologic systems with known pathways, yet they are rarely leveraged for wellness, notwithstanding extensive literature regarding healthy diets and nutrition. Gastrointestinal (GI) evolution has equipped humans with exceptional plasticity for food abundance or scarcity, while maintaining homeostasis by producing essential neurotransmitters that drive fundamental behaviors, from seeking nourishment to engaging in routine tasks of life. The advent of cheap, abundant, and highly processed foods in the last century, however, has upended the very systems that evolved for survival with a debilitating propensity for obesity in abundance—and malnourishment where access may be limited to a scarce supply of such processed foods, or none at all. In short, a better understanding and application of physiologic signaling and equilibrium is needed in cases of weight management and malnourishment. Neurotransmitters, especially serotonin, are the primary moieties that have beneficial capacity in routine tasks, consuming but not overconsumption of needed sustenance, and achieving wellness overall. Thus, this invention provides a novel delivery mechanism of micro-dosed, natural ingredients for stimulating production of a calibrated serotonin level by leveraging the gut-brain axis through organic nutrient conversion without synthetic pharmacologic compounds. Herein, specifically engineered foodstuff that converts to serotonin (or other mediators of neurobiology) is designed to facilitate weight management and may be applied to mitigate risks of malnourishment maladies such as childhood stunting by employing directed neurobiology.

The invention relates to delivery systems that allow for the pulsatile release of a substance, such as a drug, in response to a change in pH. More specifically, it relates to drug administration to the GI tract, in particular to site-specific intestinal drug delivery via the oral route. Provided is a pH-controlled pulsatile release system (PPRS) comprising a core surrounded by a coating layer, wherein said core comprises an active substance and wherein said coating layer comprises a pH-sensitive coating material wherein a swellable agent is embedded. Said swellable agent is capable of taking up at least 1.1 times, preferably at least 5 times, more preferably at least 10 times its weight in water. Also provided is a pharmaceutical composition comprising a PPRS, in particular a colon-specific PPRS.

Substituted tetrazole derivatives are useful for the prevention and/or treatment of several medical conditions including hyperproliferative disorders and diseases.

In a delayed release formulation comprising a core containing a drug and a delayed release coating for providing intestinal release, release of the drug in the colon is accelerated by including an isolation layer between the core and the delayed release coating. The delayed release coating comprises an inner layer and an outer layer. The outer layer comprises a pH dependently soluble polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a soluble polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said soluble polymeric material being selected from the group consisting of a polycarboxylic acid polymer that is at least partially neutralised, and a non-ionic polymer, provided that, where said soluble polymeric material is a non-ionic polymer, said inner layer comprises at least one additive selected from a buffer agent and a base.

The invention relates to novel a high-volume swelling hydrogel which comprises a plurality of pores which are defined by an interpenetrating network, and/or a semi-interpenetrating network and/or simple cross-linked arrangement of a plurality of one or more species of hydrophilic polymers, optionally together with one or more biocompatible polymers and optionally together with one or more plasticising agents, characterised in that at least some of the pores are at least partially collapsed and/or flattened, and further characterised in that the interpenetrating network and/or semi-interpenetrating network and/or cross-linked arrangement which defines the collapsed and/or flattened pores is substantially unbroken. The invention also relates to a process for preparing such hydrogels, and to their use as an appetite suppressant.

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.