Fuisz Technologies Ltd.

Biovail Technologies Ltd.

Biovail Laboratories International S.r.l.

Valeant International Bermuda

Steven E Frisbee

Joseph Cascone

Pradeepkumar P Sanghvi

William F Rutkowski

Mark R Herman

Bernard M Kiernan

John Getz

Richard C Fuisz

Garry L Myers

Robert K Yang

B Arlie Bogue

Tushar K Misra

John R Sisak

Andrea S Blake

Mesfin B Abdi

Barbara Montwill

Patrick B Woodall

Joan Fitzpatrick

Nils Ahlgren

John J Getz

Barry D McCarthy

Djelila Mezaache

Hanan S Anwar

Deirdre M Barrow

Naima Mezaache

Desiree Pereira

Ed O'Donnell

The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55&#xb0; C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

Controlled release dosage forms

The invention provides a composition useful for making oral dosage forms capable of dissolving in the mouth in less than 40 seconds without the need for a conventional super disintegrant and having a friability of less than 1%; wherein the composition includes liquiflash particles and an excipient mass. A preferred excipient mass according to the invention contains a directly compressible inorganic salt; a cellulose derivative or a combination of a directly compressible inorganic salt and a cellulose derivative. Preferably, the liquiflash particles and the excipient mass are combined in proportions such that the active ingredient remains substantially within the microspheres when the composition is compressed to obtain a dosage form having a hardness of 20 to 50 N. The compositions of the invention allow for the fabrication of oral dosages having improved hardness and friability.

Quick dissolve compositions and tablets based thereon

The present invention is a method of preparing a system for delivering a bio-affecting agent and the composition prepared thereby. The invention includes forming a molecular dispersion of the bio-affecting agent in an increased energy state in a water-soluble polymer which is compatible with the bio-affecting agent. As a consequence of transforming the bio-affecting agent to an increased-energy condition and freezing it in such condition in a water-soluble polymer, the bio-affecting agent is made available (&ldquo;bio-available&rdquo;) to a bio-system upon dissolution of the polymer. This method and composition has been found extremely effective for delivery of otherwise substantially non-soluble drugs and other bio-affecting ingredients.

System for rendering substantially non-dissoluble bio-affecting agents bio-available

Bioaffecting sachets, or powders, containing coated liquiflash microspheres and partially recrystallized shearform floss particles are disclosed. The sachets give organoleptically acceptable properties, including a pleasing mouthfeel, when orally ingested.

Sachet formulations

The thermoforming of compositions containing active agents is carried out by processing compositions containing certain fatty esters in combination.

Fatty ester combinations

Microspheres which disintegrate quickly in water are composed of bio-affecting agent(s), disintegrant(s) and spheronization aid(s). The microspheres, which may have taste-masking coatings, are useful in making comestible units, such as pharmaceutical dosage forms.

Disintegratable microspheres

The invention deals with microspheres which are useful in pharmaceutical dosage forms. The microspheres contain active agents and solubilizing agents which have been processed via liquiflash techniques.

Immediate release dosage forms containing microspheres

A material processing apparatus and method for processing a solid feedstock material through a melt spin process including a spinner head having a spinner head chamber defined by a parametrical processing wall through which the solid feedstock material is processed. The apparatus includes a device for rotating the spinner head about an axis of rotation to cause the feedstock material to be repelled towards and through the processing walls. A heating source separate from and exterior to the spinner head is included for heating the feedstock material to an elevated temperature to cause the melt spin processing as the feedstock material is projected through the processing wall.

Externally heated material processing apparatus and method

A spinner head is used for spinning and processing feedstock material. The spinner head includes spaced tubular heating elements which are covered by annular housing that forms a material processing wall. The annular housing contains radially spaced slots which provide a passage way for the material to be expelled from the spinner head. Each slot contains a flow restricting insert removably insertable therein. The inserts include radially extending grooves which channel the feedstock material as it exits the spinner head. The insert further include latches extending therefrom which secure the inserts in the spinner head upon rotation.

Spinner head having flow restricting inserts

Growing community of inventors

Reston, VA, United States of America

Steven E Frisbee