Aptalis Pharmatech, Inc.

Adare Pharmaceuticals, Inc.

Eurand Pharmaceuticals, Ltd.

Eurand, Inc.

Nehal H Vyas

Gopi M Venkatesh

Jin-Wang Lai

Michael Gosselin

Krishna S Vishnupad

Michael A Gosselin

Vivek Purohit

Philip J Percel

M Venkatesh Gopi

Gopi Venkatesh

The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.

Orally disintegrating tablet compositions of lamotrigine

The present invention is directed to pharmaceutical compositions, and methods of making such compositions, wherein the compositions comprise a plurality of TPR and RR particles, wherein: the TPR particles each comprise a core coated with a TPR layer; the core comprises a weakly basic, poorly soluble drug and a pharmaceutically acceptable organic acid separated from each other by an SR layer; the RR particles each comprise the weakly basic, poorly soluble drug, and release at least about 80 wt. % of the weakly basic, poorly soluble drug in about 5 minutes when dissolution tested using United States Pharmacopoeia (USP) dissolution methodology (Apparatus 2&#x2014;paddles@50 RPM and a two-stage dissolution medium at 37&#xb0; C. (first 2 hours in 0.1N HCl followed by testing in a buffer at pH 6.8).

Drug delivery systems comprising weakly basic drugs and organic acids

A unit dosage form, such as a capsule or the like, for delivering drugs into the body in a circadian release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release drug delivery system is designed to provide a plasma concentration-time profile, which varies according to physiological need at different times during the dosing period, i.e., mimicking the circadian rhythm and severity/manifestation of gastric acid secretion (and/or midnight gerd), predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.

Pulsatile release histamine H2 antagonist dosage form

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Huber Heights, OH, United States of America

Nehal H Vyas