Hercules Corporation

Isp Investments Inc.

Other

Thomas Durig

Divya Tewari

Yevgeniya A Titova

Brad Beissner

Richard A Salzstein

Yunxia Bi

James David Lester

Randy Bull

Ronald Haywood Hall

The present invention provides a coprocessed excipient composition and a method of producing the same. The coprocessed excipient comprises vinyl lactam derived polymer and a deagglomerated coprocessing agent. The coprocessing agent is fumed silica, colloidal silica or silicon dioxide. The coprocessed excipient is prepared by a continuous process and has a Brookfield cohesion of less than 0.12 kPa, a bulk density of at least 0.249 gram/milliliter and a flow property as measured by Johanson flow rate number increase from 1.1 to 5.0 fold.

Coprocessed silica coated polymer composition

An excipient composition having good bulk density and improved flow characteristics is provided. The present invention particularly provides a coprocessed excipient composition and a method of producing the same. The coprocessed excipient comprises cellulose derived polymer and a deagglomerated coprocessing agent. The coprocessing agent is fumed silica, colloidal silica or silicon dioxide. The coprocessed excipient is prepared in a continuous process and has excellent compactability and improved flow property as measured by Johanson flow rate number increase from 1.1 to 5.0 fold, is characterized by a Brookfield cohesion factor of less than 0.2 kPa and a bulk density of at least 0.249 g/ml.

A stable and high loading ternary solid dispersion composition comprising (a) about 50% wt. to about 90% wt. of amorphous Efavirenz; (b) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone (PVP), a first polymer; (c) about 1% wt. to about 30% wt. of a water-soluble second polymer; and (d) optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Also discloses a high loading ternary composition comprising (a) a solid dispersion composition comprising (i) about 50% wt. to about 90% wt. of amorphous Efavirenz; (ii) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone, a first polymer; (b) about 1% wt. to about 30% wt. of a water-soluble second polymer blended with solid dispersion of composition of (a); and (c) optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Additionally discloses a method for preparing solid dosage forms comprising (i) amorphous Efavirenz and (ii) polyvinyl pyrrolidone (PVP), a first polymer; (iii) a water-soluble second polymer; and (iv) optionally, at least one pharmaceutical excipients.

Highly loaded amorphous efavirenz composition and process for preparing the same

The present invention relates to a film coating composition used for film coating pharmaceutical tablets, nutritional supplements, confectionary forms and the like. The film coating composition comprises a water soluble film former such as hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, starches, modified starches and the like and one or more hydrophobic compounds, such as metal salt of higher fatty acids, higher fatty alcohol, natural wax either from vegetable, animal origin or synthetic wax. Optionally, the film coating composition may include plasticizers, colorants, such as pigments and/or flow aids.

Film coating composition from solid powder hydrophobic compounds

A pharmaceutical dosage form composition is composed of an ethylcellulose that has an ethoxyl range lower limit of 49.6%, an a viscosity of less than 53 cps and at least one active pharmaceutical ingredient. This dosage form is highly compressible and compactible forming harder tables or pellets with better release retardation than comparable prior art tablets.

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Chadds Ford, PA, United States of America

Thomas Durig