Use of a combination of a histone deacetylase inhibitor and a protein kinase inhibitor in the preparation of a medicament for the treatment or prevention of tumors, a pharmaceutical composition comprising a histone deacetylase inhibitor and a protein kinase inhibitor as active ingredients, and a method for treating or preventing cancers by combining a histone deacetylase inhibitor and a protein kinase inhibitor.

A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.

The present invention relates to pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation and their use to treat diabetes mellitus.

This invention provides novel solid pharmaceutical compositions and processes for the bulk production of said compositions This invention also provides methods of using the pharmaceutical compositions in the treatment of cancer.

Immediate release formulation of a triple combination of active pharmaceutical ingredients useful in the treatment of polycystic ovarysyndrome It relates to an immediate release formulation for oral administration, comprising; a) a combination of three active pharmaceutical ingredients which are spironolactone; pioglitazone or a salt thereof; and metformin or a salt thereof; and b) solid polyethylene glycol having an average molecular weight from 3350 to 8000 g/mol; wherein: each of the active pharmaceutical ingredients are present in a therapeutically effective amount; and the polyethylene glycol is present in an amount such that decreases the dissolution profiles in vitro of each one of the active pharmaceutical ingredients without modifying the disintegration time of the formulation compared with the dissolution profiles of each one of the active pharmaceutical ingredients of a formulation having the same composition but without the solid polyethylene glycol, as well as, to its preparation process.

The present invention relates to a controlled release oral formulation comprising about 400 mg to about 800 mg of flavoxate salt as an active ingredient, suitable polymers, binders, and excipients, and lacking an acidifying agent. The present invention also provides a method of preparing the controlled release oral formulation of about 400 mg to 800 mg of flavoxate salt. The controlled release formulation of present invention may comprise micronized particles of drug. The controlled release formulation has a controlled release profile of up to 24 hours, that is pH independent, and that is alcohol dose dumping risk-free.

The present invention relates to a process for preparing a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an active pharmaceutically ingredient (API). The tablet comprises a granulate comprising said at least freely soluble solid form of an active pharmaceutically ingredient in form of granules, and a tablet base, with the granules exhibiting a certain minimum size, and the tablet base comprising a disintegrant. The process comprises a step of mixing the API-containing granulate with the tablet base, followed by a step of compressing the mixture to form the tablet. The present invention also relates to a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an API, wherein said tablet comprises a mixture of API-containing granulate comprising API-containing granules, and a disintegrant-containing tablet base, with the granules exhibiting a certain minimum size. The amount of said API in the tablet is at least 10% w/w based on the weight of the tablet.

A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

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.

Formulations and methods of manufacturing formulations for use in colonic evacuation are disclosed herein, in an embodiment, a solid dosage formulation includes an intra-granular fraction intermingled with an extra-granular fraction, wherein the intra-granular fraction includes granules comprising at least one osmotic evacuant agent, at least one antacid, and a first pharmaceutically acceptable excipient component, and wherein the extra-granular fraction includes one or more organic acids, a non-metallic lubricating element, and a second pharmaceutically acceptable excipient component.