A crystalline form of 6-{2-[1-(6-methyl-3-pyridazinyl)-4-piperidinyl]ethoxy}-3-ethoxy-1,2-benzoxazole is provided which is useful in the treatment of infections caused by Picornaviridae such as human rhinovirus (HRV), and in particular the crystal form is an anhydrous crystalline free base form of 6-{2-[1-(6-methyl-3-pyridazinyl)-4-piperidinyl]ethoxy}-3-ethoxy-1,2-benzoxazole. In addition, a method of manufacturing the free base crystalline form is also provided, including a step of micronizing the compound particles, optionally using a wetting agent, as well as pharmaceutical compositions incorporating the free base crystalline form such as tablets or suspensions, and methods of therapeutic treatments using this form and pharmaceutical compositions thereof.

An extended-release drug delivery composition and method of administering the same is provided. The composition comprises microspheres loaded with a biologically-active agent and suspended in a soluble polymer capable of forming a film upon injection onto a biological surface.

Disclosed herein is a pharmaceutical combination composition comprising stable complexes with controlled particle size, increased apparent solubility and increased dissolution rate comprising as active compound Ivacaftor and Lumacaftor, their salts, or derivatives thereof, which is useful in the treatment of cystic fibrosis transmembrane conductance regulator (CFTR) mediated disease. More specifically, the pharmaceutical composition comprising the complexes possesses instantaneous redispersibility, increased apparent solubility and permeability, no observable food effect which deliver the opportunity of precise dosing and ease of administration of the reconstituted complex in solution form. Further disclosed are methods of formulating and manufacturing said complexes, pharmaceutical compositions containing said complexes, and methods of treatment using said complexes and their pharmaceutical compositions.

Solid dispersions and dosage forms comprising the hydrobromide salt of a diarylpyrimidine derivative, useful as an anti-HIV agent.

The invention relates to a pharmaceutical dosage form for oral administration comprising a pharmacologically active compound; wherein a portion of said pharmacologically active compound is contained in a multitude of immediate release particles providing immediate release of the pharmacologically active compound; wherein another portion of said pharmacologically active compound is contained in at least one controlled release particle providing controlled release of the pharmacologically active compound; and wherein the breaking strength of each of the immediate release particles and/or of the at least one controlled release particle is at least 300 N.

This invention provide novel compositions, methods and devices for sustained drug delivery. The compositions can include a fluid carrier; a plurality of first polymeric microparticles having a bioactive agent dispersed in the fluid carrier; and a plurality of second polymeric microparticles having a visualization agent dispersed in the fluid carrier with the first microparticles. Alternative compositions can include: a fluid carrier; and a plurality of polymeric microparticles having a bioactive agent encapsulated therein and a visualization agent on a surface of the polymeric microparticles, the plurality of polymeric microparticles being dispersed in the fluid carrier. The microencapsulated sustained drug delivery compositions are deposited using oscillating needle apparatus oscillating at 10-12000 minutes per minutes at an amount of 1.0E-03 mL to 1.0E-16 mL per injection.

In accordance with the present invention, disclosed herein is a kit comprising a first mixture comprising a pharmaceutically acceptable polar liquid and a fully or nearly fully dissolved biodegradable polymer; a second mixture comprising a pharmaceutically acceptable non-polar liquid; and a mixing device configured to mix the first mixture and second mixture, thereby forming a droplet comprising the biodegradable polymer. Also disclosed herein are methods of producing a microparticle in vivo in a subject.

Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.

Compositions for stabilizing and delivering proteins and/or other bioactive agents are disclosed. The bioactive agents are embedded or encapsulated in a crystalline matrix. Typically the bioactive agents are in the form of micro- or nanoparticles. The crystalline matrix confers enhanced stability to the agents embedded therein relative to other microparticulate or nanoparticulate bioactive agents. The carriers are especially useful for stabilizing bioactive macromolecules, such as proteins.

The present invention provides a highly palatable colon cleansing formulation that utilizes a low chloride electrolyte-replenishing base solution. When formulated with polyethylene glycol and a selected sugar alcohol, the formulation offers the advantages of superior palatability without undesirable concomitant side effects or a decrease in cleansing efficacy.