This invention relates to drug delivery and in particular to the delivery of biologically active agents in the form of dry powders for inhalation. The invention also relates to methods for preparing such dry powder formulations and methods for their use.

A pharmaceutical composition having consistently a desirable release rate is prepared by controlling the finally mixing time based on the molecular weight measured in the intermediate product. The pharmaceutical composition includes micro particles containing a polyhydric alcohol, a salt, a water-soluble polymer and a pharmaceutically active ingredient. The micro particles are dispersed in a matrix of a hydrophobic ingredient and an amphipathic ingredient.

The invention provides cyclodextrin inclusion complex delivery vehicles, in which the cyclodextrin inclusion complex is provided together with enzyme having a cyclodextrin-degrading activity capable of digesting the cyclodextrin, so that upon delivery of the vehicle to a target the enzyme is activated and releases the guest molecule from the cyclodextrin cavity. In alternative aspects, these cyclodextrin inclusion complex delivery vehicles are for example provided in the form of medicaments, food ingredients, medical food ingredients, nutritional supplement ingredients, dietary supplement ingredients, herbicides, insecticides, fungicides, animal repellents, pheromones, plant growth regulators, fragrances, fabrics or packaging materials.

A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

A composition comprising at least one amino acid, (ii) a controlled release lipid matrix, and optionally (iii) at least one acceptable pharmaceutical or food grade additive and/or excipient and a related method for the treatment of amino acid supply or protein deficiency in a monogastric subject, preferably a human subject or a pig, are disclosed as well as a feed or feed additive comprising the composition for a monogastric animal, preferably a pig.

The invention relates to an aqueous granulation process for preparing granules comprising an amorphous poorly water soluble active pharmaceutical ingredient, a particular polymer and a particular surfactant. The invention also refers to a process for preparing tablets comprising said granules. Furthermore, the invention refers to granules and tablets obtainable by the process of the invention.

The invention related to dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutics agents to patients.

The present invention relates to compositions comprising at least one lactose component, at least one cellulose component and at least one starch component, its preparation and its use, particularly as a direct tabletting excipient.

An improved stabilization buffer for use in the lyophilization of Neospora and other protozoans is disclosed. Also disclosed is an improved lyophilization method, which includes controlling ice nucleation during the freezing step.