Kos Pharmaceuticals, Incorporated

Baker Norton Pharmaceuticals, Inc.

Jose Gutierrez-Rocca

Josephine Dunne

Saul A Rios

Janice Louise Cacace

Sami Selim

Robert Testman

Hossein Omidian

J Michael Rutledge

The present invention features a method for the formation of superporous hydrogels using an ion-equilibration technique. Anionic polysaccharides are included in the hydrogel reaction mixture and cations are introduced either during or after hydrogel formation. Properties of the resulting hydrogel can be subsequently adjusted by treating the cation-complexed gel with a different cation or cation mixture under equilibrating conditions. It has been found that by properly adjusting the cations and the sequence in which they are used in the equilibration process, superporous hydrogels can be formed that are highly absorbent while maintaining favorable structural properties, including strength, ruggedness, and resiliency. It has also been found that applying appropriate dehydration conditions to them after their formation can further stabilize the superporous hydrogels formed by the method of the invention.

Formation of strong superporous hydrogels

Pharmaceutical compositions for oral administration to mammalian subjects comprise a taxane or taxane derivative (e.g., paclitaxel or docetaxel) as active ingredient and a vehicle comprising at least 30% by weight of a carrier for the taxane, said carrier having an HLB value of at least about 10. The compositions may also comprise 0&#x2013;70% of a viscosity-reducing co-solubilizer. The compositions may be incorporated into conventional oral pharmaceutical dosage forms, or can be in the form of a two-part medicament wherein the first part includes the taxane in a solubilizing vehicle and the second part comprises a carrier for the taxane to promote oral absorption. Methods of treatment of taxane-responsive disease conditions employing the novel compositions are also disclosed, whereby the compositions can be administered alone or in association with an oral bioavailability enhancing agent.

Oral pharmaceutical compositions containing taxanes and methods of treatment employing the same

A sustained/prolonged release pharmaceutical dosage form is disclosed. The form comprises a hard shell capsule and a formulation comprising (a) a water insoluble medicant, (b) a high melting fatty ester, (c) a low viscosity oil, (d) a cellulosic polymer, and (e) a non-ionic surfactant.

Controlled release pharmaceutical composition

A sustained/prolonged release pharmaceutical dosage form is disclosed. The form comprises a hard shell capsule and a formulation comprising (a) a water insoluble medicament, (b) a high melting fatty ester, (c) a low viscosity oil, (d) a cellulosic polymer, and (e) a non-ionic surfactant.

A controlled release pharmaceutical formulation is disclosed. The formulation comprises a construct having a matrix of a material selected from the group comprising (a) a high melting point fatty acid ester, (b) an oil, (c) a polymeric cellulose derivative and (d) a mixture of any of the foregoing. Associated with the matrix is a selected medicament. Preferably, the matrix comprises at least two of the aforementioned materials or components.

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Miami, FL, United States of America

Jose Gutierrez-Rocca