Pfizer Corporation

Kenneth C Waterman

Michael C Roy

Dwayne Thomas Friesen

William John Curatolo

Douglas Alan Lorenz

Avinash G Thombre

Ronald Arthur Beyerinck

Mark B Chidlaw

Mary T Am Ende

Scott W Smith

Michael B Fergione

Sara Kristen Moses

Danni Supplee

Leah A Appel

The present invention is directed to controlled-release (CR) oral pharmaceutical dosage forms of 5,8,14-triazatetracyclo[10.3.1.00]-hexadeca-2(11),3,5,7,9-pentaene, 1, and pharmaceutically acceptable salts thereof, and methods of using them to reduce nicotine addiction or aiding in the cessation or lessening of tobacco use while reducing nausea as an adverse effect. The present invention also relates to an immediate-release (IR) low dosage composition having a stable formulation with uniform drug distribution and potency. 

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Forming amorphous atorvastatin comprises the steps of dissolving atorvastatin in a hydroxylic solvent, followed by rapidly evaporating the solvent. In another aspect, a composition comprises particles of amorphous atorvastatin and a core.

Process for forming amorphous atorvastatin

A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt % per hour from the second to the twenth hour after introduction to a use environment and less than about 25 wt % for the first two hours and at least 70 wt % by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet. In another embodiment, the dosage form releases less than about 25 wt % of sertraline to the use environment by the second hour after introduction of the dosage form to the use environment, and delivers at least 25 wt % from the eighth to the twenty-fourth hour.

Hydrogel-driven layered drug dosage form

Pharmaceutical kits are provided that reduce or prevent oxidative degradation of oxygen-sensitive pharmaceutically active ingredients in solid unit dosage forms that are supplied in oxygen permeable containers. Stabilization of the active ingredient is accomplished by incorporating an oxygen absorber into a sealed oxygen permeable container.

Pharmaceutical kit for oxygen-sensitive drugs

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East Lyme, CT, United States of America

Kenneth C Waterman