Disclosed are taste-masked pharmaceutical formulations of raltegravir comprising coated API granules mixed with a screened powder excipient blend in either tablet or sachet form. The core and coated granules are produced using a Wurster process for enhanced control of particle size. Also disclosed are methods of treating HIV, e.g., in pediatric populations.

The present invention relates to a sprinkle composition of cinacalcet which provides a dissolution profile which is comparable to the currently marketed tablet dosage form.

The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.

Provided is method of making an aqueous composition comprising (a) providing a mixer comprising a sealable volume and one or more rotors inside said sealable volume; (b) placing into said sealable volume ingredients comprising ethylcellulose polymer and fatty acid; (c) placing into said sealable volume ingredients comprising water and a water-soluble base; (d) sealing said sealable volume after said steps (b) and (c); (e) then rotating one or more of said rotors while said ingredients are at a temperature above the softening point of said ethylcellulose polymer, to produce said aqueous composition; wherein said step (e) is conducted so that 90% or less of the volume of said ingredients is uncontacted by one or more of said rotors.

The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.

The present invention provides compositions for the treatment of phenylketonuria in mammals, as well as methods of preparing said compositions. The present invention also provides methods of treating phenylketonuria using the compositions of the invention.

The invention relates to a formulation for the delayed and controlled delivery of an adsorbent into the lower intestine of mammals. The formulation includes a carrageenan and an adsorbent, such as activated charcoal. The invention further relates to uses of this formulation, in particular to pharmaceutical uses. In one embodiment, the formulation is used to eliminate or reduce the side effects in the intestine, in particular in the colon, of pharmaceutical agents that are administered as a treatment for a disorder, but that have side effects when they reach the late ileum, the caecum or the colon.

Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.

A composition-of-matter is provided. The present composition includes dietary supplements capable of reducing or reversing the negative effects of alcohol on motor and cognition, dietary supplements having anti-gastroparesis, antiemetic, analgesic and anti-inflammatory activities and/or dietary supplements capable of increasing alcohol catabolism and decreasing the level of toxic products of alcohol catabolism.

Provided are immediate or prolonged administration of certain potassium ATP (K.sub.ATP) channel openers to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving K.sub.ATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of K.sub.ATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are method of co-administering K.sub.ATP channel openers with other drugs to treat diseases of humans and animals.