Solid pharmaceutical formulations including AZD4635 are described. The solid formulations can include a polymeric stabilizer (e.g., a polyvinylpyrollidone), an ionic surfactant (e.g., sodium docusate), and a non-ionic surfactant (e.g., a poloxamer).

The invention relates to a method of enhancing the solubility and/or the rate of dissolution of a Class II or Class IV low solubility molecule, a method of producing a spray-dried composition, and a spray-dried composition comprising a Class II or Class IV low solubility molecule, albumin and an agent that prevents self-aggregation of albumin.

Provided herein are lipid compounds that can be used in combination with other lipid components, such as neutral lipids, cholesterol and polymer conjugated lipids, to form lipid nanoparticles for delivery of therapeutic agents (e.g., nucleic acid molecules) for therapeutic or prophylactic purposes, including vaccination. Also provided herein are lipid nanoparticle compositions comprising said lipid compounds.

Embodiments described herein relate generally to compounds comprising allyl lactide residues. One aspect described herein relates generally to a compound or a pharmaceutically acceptable salt thereof, comprising allyl lactide residues and lactide residues, wherein the compound or pharmaceutically acceptable salt thereof is substantially free of valerolactone residues. Another aspect relates to a method of incorporating a drug into a compound, comprising: (i) providing a compound or a pharmaceutically acceptable salt thereof, comprising allyl lactide residues and lactide residues, wherein the compound or pharmaceutically acceptable salt thereof is substantially free of valerolactone residues; (ii) incubating the compound and a drug in the presence of a solvent for an incubation period to form a drug-loaded compound; and (iii) separating the drug-loaded compound from the solvent.

The present disclosure relates to a continuous process for impregnating active pharmaceutical ingredients (API) onto porous carriers, including the steps of introducing a porous carrier into a first feeder; continuously directing the porous carrier from the first feeder into a continuous blender, wherein the continuous blender comprises one or more nozzles; continuously introducing a solution comprising an API dissolved in solvent into the continuous blender through the one or more nozzles to form API-impregnated porous carrier; and continuously drying the API-impregnated porous carrier using a fluidized bed dryer to form a powder. The present disclosure also relates to a continuous process for manufacturing pharmaceutical drug products using continuously manufactured API-impregnated porous carriers. The present disclosure also relates to a continuous pharmaceutical drug manufacturing process that includes API-impregnated porous carriers as a raw material.

The invention relates to an extract of Ashwagandha that exhibit enhanced bioactivity and bioavailability comprising of enriched withanolide glycosides and saponins; with negligible amount of alkaloids, withanolide aglycones and oligosaccharides. The extract as disclosed prepared from root, stems, leaves and whole plant of Ashwagandha further shows improved immunomodulatory activity, anti-inflammatory activity, anti stress activity, antidiabetic activity and sleep quality. The disclosure also provides a method of improving bioactivity of withanolide glycosides even at lower doses, by the administration of an enteric coated formulation of extract of Ashwagandha to humans. The enteric coating protects the composition from hydrolysis in the acidic environment of the stomach to release the withanolide glycoside in neutral/ alkaline pH in gastrointestinal tract (GIT) thus enhancing the absorption. Further the process of preparation of the extract of Ashwagandha enriched with withanolide glycosides and saponins are disclosed along with various formulations.

According to one embodiment of the present invention, granules having a high content of an active ingredient and a high uniformity of particle size are provided. Alternatively, according to one embodiment of the present invention, a preparation containing granules having a high content of an active ingredient and a high uniformity of particle size is provided. According to one embodiment of the present invention, a granule is provided that comprises a nuclear material, a melt component layer arranged on a surface of the nuclear material, and an active ingredient-containing layer arranged on a surface of the melt component layer, wherein the melt component layer contains a first melt component and the active ingredient-containing layer contains an active ingredient and a second melt component or a polymer having compatibility with the first melt component.

The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

The present invention relates to the field of methods for providing pharmaceutical compositions comprising poorly water-soluble drugs. In particular the present invention relates to compositions comprising stable, amorphous hybrid nanoparticles, comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix-forming component, useful in pharmaceutical compositions and in therapy.

It is provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of transthyretin-associated amyloidosis. It is also provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of transthyretin-associated amyloidosis in combination therapy with another COMT inhibitor, a benzoxazole derivative, iododiflunisal, diflunisal, resveratrol, tauroursodeoxycholic acid, doxocycline, or epigallocatechin-3-gallate.