A method of producing an extruded, powdered/granulated composition comprising an active pharmaceutical ingredient (API), by the steps of providing an API and a porous inorganic excipient, and processing them by an extrusion process to directly produce an extruded, powdered/granulated composition wherein the API is at least partially absorbed within the pores of the inorganic excipient. In preferred embodiments, the API is melted, or solubilised in a solubilizer.

The invention provides a tamper-resistant dosage form including a therapeutic agent-substrate complex embedded in a thermo-formable matrix; such that the complex includes at least one therapeutic agent bound to at least one substrate to form the therapeutic agent-substrate complex. The at least one substrate is being selected from the group consisting of a polyelectrolyte, an organic counter-ion, a pharmacologically inert organic component of a prodrug, an inclusion compound and an inorganic adsorbent; and the thermo-formable matrix includes one or more thermoplastic polymers and optionally at least one pharmaceutical additive.

The present invention features solid pharmaceutical compositions comprising Compound 1 and Compound 2. In one embodiment, the solid pharmaceutical composition includes (1) a first layer which comprises 100 mg Compound 1, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion; and (2) a second layer which comprises 40 mg Compound 2, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion.

The present invention relates to a monolayer tablet for use in the treatment of tuberculosis comprising a mixture of: —granules comprising isoniazid, pyrazinamide, ethambutol or a pharmaceutically acceptable salt thereof and at least one granulation binder, —rifampicin in powder form, —extragranular excipients, wherein all of the granules have a particle size that is less than 0.599 mm, preferably less than 0.5 mm, more preferably less than 0.422 mm, and to its process of preparation.

Cenicriviroc (CVC) is an orally active antagonist of ligand binding to C-C chemokine receptor type 5 (CCR5) and C-C chemokine receptor type 2 (CCR2). CVC blocks the binding of RANTES, MIP-1α, and MIP-1β to CCR5, and of MCP-1/CCL2 to CCR2. Methods of treating fibrosis and related conditions comprising co-administration of CVC with FXR agonists, high dose vitamin E (>400 iU/d), a peroxisome proliferator-activated receptor alpha (PPAR-α) agonist, PPAR-γ agonist, PPAR-δ agonist and/or chemokine antagonists are provided herein.

The present invention includes a pharmaceutical composition, and methods of making and using, a pharmaceutical composition comprising one or more thyroid hormone(s) or analogs thereof, wherein a first portion of thyroid hormone(s) is formulated for immediate release and a second portion of thyroid hormone(s) is formulated of modified release, e.g., by forming a drug-resin particle with an ion exchange resin.

This invention relates to swallowable tablets containing at least 80% by weight of N-acetylcysteine (NAC) and at least one pharmaceutically acceptable excipient, in particular tablets in which the sulfurous odor is absent, characterized in that the said tablets are assembled using a granulate prepared by means of a process of dry granulating the active ingredient alone, with which the excipients are mixed before compression.

The invention relates to a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a second coating comprising a second active ingredient.

The present invention is an orally consumed fixed combination formulation of both rosuvastatin and ezetimibe in one tablet that is expected to have the same Area Under Curve as two active ingredients taken together individually orally, and pharmaceutically acceptable additives suitable for the preparation. In preferred embodiments of this invention, the rosuvastatin is in the form of rosuvastatin calcium and the pharmaceutically acceptable additives are selected from diluents, disintegrants, glidants, lubricants, colorants and combinations thereof.

The present disclosure is directed to, inter alia, methods of treating a subject suffering from or diagnosed with depression, comprising administering to a subject in need of such treatment an effective amount of a compound of formula (I), or a pharmaceutically acceptable salt thereof, wherein R.sup.1 to R.sup.4 are described herein and wherein the compound is administered prior to sleep.

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