Bpsi Holdings, Inc.

New Jersey Institute of Technology

Daniel To

Jason Teckoe

Rajesh N Dave

Jeffrey R Gimbel

Bradley J Prusak

George Reyes

Ecevit A Bilgili

Raxitkumar Y Mehta

Catharina Knieke

Mohammed A Azad

Maxx Capece

The present invention includes acidifying film coating compositions containing a polymer and an acidic component for use on orally-ingestible substrates such as tablets and the like. The acidifying coating compositions can be applied as an aqueous dispersion to an enteric-coated substrate to increase the disintegration resistance to aqueous media of up to pH 5.0. In preferred aspects, the acidic component is citric acid, lactic acid, stearic acid or mixtures thereof. Methods of preparing the dry film coatings, methods of preparing corresponding aqueous dispersions, methods of applying the coatings to substrates and the coated substrates themselves are also disclosed.

Acidifying coatings and disintegration-resistant substrates coated therewith

The present invention is directed to film coating compositions for use on oral dosage forms such as compressed tablets and other orally-ingestible substrates which contain a water-soluble polymer and guar gum. The film coating compositions can be applied either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the water-soluble polymer is a cellulosic or vinyl polymer. Aqueous suspensions containing the inventive film coating compositions and the coated substrates themselves are also disclosed. The resulting coated substrates have relatively low coefficients of static and dynamic friction on wet surfaces rendering them easier to swallow than prior art compositions.

Easy to swallow coatings and substrates coated therewith

A composite particle including a core with at least one carrier material; a fluidizing material layer on the surface of the core; and an outer layer comprising nanoparticles of an ingestible material distributed in at least one matrix-forming material. A process of making the composite particles includes the steps of dry coating carrier particles with a fluidizing material; preparing a suspension of nanoparticles of an ingestible material distributed in a matrix-forming material; and fluid bed coating the carrier particles with the suspension. The process and products provide quick dissolving composite particles which can be used for delivery of poorly water soluble ingestible materials in suitable dosage forms. The process of the invention reduces or prevents particle agglomeration during fabrication of the composite particles to enable delivery and quick redispersion of nanoparticles of the ingestible material from a dosage form.

Pharmaceutical core-shell composite powder and processes for making the same

The present invention is directed to immediate release film coating compositions for use on oral dosage forms such as compressed tablets and other orally-ingestible substrates which contain medium chain glycerides as detackifiers. The film coating compositions can be applied either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the polymer is polyvinyl alcohol and the medium chain glycerides are mixtures of caprylic (8 carbon chain) and capric (10 carbon chain) mono- and diesters of glycerin. Aqueous suspensions comprising the inventive film coating compositions, methods of applying the coatings to substrates and the coated substrates themselves are also disclosed.

Immediate release film coatings containing medium chain glycerides and substrates coated therewith

The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.

Solventless mixing process for coating pharmaceutical ingredients

A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

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North Wales, PA, United States of America

Daniel To