Andrx Pharmaceuticals, Inc.

Mylan Pharmaceuticals Inc.

Mylan Gmbh

Andrx Corporation, Inc.

Other

Mylan Laboratories Limited

Andrx Labs, LLC

Mylan Specialty LP

Boyong Li

Avinash Nangia

Xiu Xiu Cheng

Chih Ming Chen

Mummini Aruna Murty

Chih-Ming Chen

Dacheng Tian

Jack Cardinal

David T Rossi

James Paul McCall

Janice Louise Cacace

David N Wong

Thomas Daniel Reynolds

David John Wargo

Monte Browder

Aaron Dely

Jason Neely

Chaoju Xiao

James Paul Mccall

Thomas D Reynolds

The presently disclosed subject matter is directed to a granule, wherein the granule has an active agent and a wax dispersed therein, and the granule exhibits excellent friability when compressed to form a pharmaceutical composition. The subject matter disclosed herein is also directed to methods of preparing the granules and the pharmaceutical compositions comprising the granules. The compositions and methods disclosed provide granules and pharmaceutical compositions for immediate release of the active agent and do not substantially prolong the release of the active agent from the granule.

Hot melt granulation formulations of poorly water-soluble active agents

Pharmaceutical compositions in the form of tablets are disclosed including water-soluble active ingredients such as levetiracetam and a polymer component which primarily includes water-insoluble polymers comprising between 60% and 100% of the polymer component in the tablet core, preferably the entire polymer component in the tablet core. The pharmaceutical compositions can also include an extended-release coating including both water-soluble and water-insoluble polymers.

Controlled release levetiracetam formulations and methods for producing the same

The present invention provides a delayed and/or controlled release formulation of paroxetine or a pharmaceutically acceptable salt thereof that is formulated to release a substantial portion of the active ingredient (e.g., paroxetine) in the large intestine of an individual in need thereof. In one embodiment, the present invention provides a controlled release paroxetine composition comprising paroxetine or a pharmaceutically acceptable salt thereof, in a controlled release swallow pharmaceutical formulation, that upon administration, releases the paroxetine substantially in the large intestine. For example, the controlled release paroxetine formulation may be formulated to release greater than about 50% of the paroxetine in the large intestine.

Formulation and method for the release of paroxetine in the large intestine

Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, and an extended release polymer. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

Controlled release budesonide minitablets

Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, an extended release polymer, and an acid. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

A method of making a pharmaceutical composition containing tolterodine L-tartrate stabilized against degradation with an acid. Acid-stabilized tolterodine L-tartrate may be used as an active ingredient in various types of immediate release and controlled release dosage forms, including tablets, capsules, and beads.

Stabilized tolterodine tartrate formulations

A once a day bupropion salt formulation is disclosed.

Controlled release oral dosage form

A once a day bupropion hydrochloride formulation is disclosed.

Stabilized controlled release pharmaceutical preparations are disclosed in which active ingredient degradation is prevented without the use of a stabilizer. The active ingredient is sealed away from excipients that can adversely affect stability by sealing the excipients rather than the active ingredient. The preparations are substantially unaffected by exposure to storage conditions of elevated temperature and/or elevated relative humidity.

Stable pharmaceutical compositions without a stabilizer

A pharmaceutical composition contains tolterodine L-tartrate stabilized against degradation with an acid. Acid-stabilized tolterodine L-tartrate may be used to make various types of immediate release and controlled release dosage forms.

A drug composition comprising a coated bead is used in the manufacture of immediate release and/or controlled release drug compositions. In a specific embodiment, the bead includes an inert core of a water-soluble or water-swellable material, which has been coated with a seal layer formed from a non-polymeric hydrophobic material. The immediate and/or controlled release beads may be used to form tablets or capsules. A method of making the beads by sequential deposition of multiple layers on the inert cores is also described.

Drug formulations having inert sealed cores

Stabilized pharmaceutical preparations containing a drug in which is sensitive to a low pH environment, such as pravastatin are disclosed in which pravastatin degradations is prevented with a buffering agent. The basic excipient enhances storage stability.

Stable pharmaceutical compositions containing pravastatin

The invention is directed to controlled release formulations containing drugs which are preferably considered sparingly soluble to insoluble and which are suitable for administration to a patient in need of treatment related thereto, and methods of manufacturing the same.

Oral extended-release composition

The present invention comprises a device and methods for dissolution or immersion testing and, in particular, a device and methods that improve the consistency of test results by limiting the ability of pharmaceutical or other dosage forms to move or reorient during testing.

Growing community of inventors

Morgantown, WV, United States of America

Boyong Li