Ascent Pediatrics, Inc.

Ascent Pharmaceuticals, Inc.

Glaxosmithkline LLC

Reliant Pharmaceuticals, Inc.

Abdel A Fawzy

Emmett Clemente

Aloysius O Anaebonam

George Bobotas

Robert W Mendes

Eric M Morrel

Pharmaceutical compositions in unit dose form comprising capsules containing one or more first active pharmaceutical ingredient in a pharmaceutically acceptable vehicle, coated with one or more second active pharmaceutical ingredients, wherein the unit dose form is a pharmaceutical grade finished dosage form, and methods of making and using the same.

Coating capsules with active pharmaceutical ingredients

This invention relates to new pharmaceutical compositions and methods for their preparation, and in particular it relates to taste-masked liquid compositions comprising a solution of a histamine H-antagonist complexed with an alginate and also containing a humectant. The solution is buffered to a pH of between about 6 to 7. The inventive solution may be flavored and sweetened and preserved.

Liquid pharmaceutical composition

An extended release acetaminophen composition comprises a plurality of discrete particles containing acetaminophen which, when contained within a gelatin capsule and assayed in a USP Apparatus I rotating basket at 50 rpm in 900 mL of phosphate buffer at pH 5.8 and 37.degree. C., exhibits about 40 percent to about 53 percent acetaminophen dissolution at one-half hour, about 50 percent to about 68 percent dissolution at 45 minutes, about 57 percent to about 77 percent acetaminophen dissolution at one hour, and about 82 percent to about 92 percent acetaminophen dissolution at two hours. After six hours, the contemplated extended release acetaminophen composition exhibits substantially complete dissolution. A process for treating a human patient with the extended release acetaminophen composition is also disclosed.

Extended release acetaminophen particles

Pleasant-tasting aqueous liquid composition of a bitter-tasting drug

A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol. That aqueous medium consists essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants. The liquid composition is transparent and has a pleasant taste.

The present invention contemplates a dry, granular terfenadine composition. That composition comprises (i) particulate terfenadine and (ii) a polyethylene oxide-polypropylene oxide-polyethylene oxide block copolymer having an HLB number of 24 that is a wetting agent for the terfenadine that are dry-blendedly dispersed onto (iii) spray-dried sorbitol particles that are loosely packed, randomly oriented filamentary crystals having pores that entrap the particulate terfenadine and wetting agent upon the dry-blended dispersal. The weight ratio of particulate terfenadine to the block copoymer is about 1:1 to about 1:5:1, and the weight ratio of terfenadine to the spray-dried sorbitol is about 1:4 to about 1:10. The composition is free-flowing and is substantially free from the taste of solubilized terfenadine when placed on the human tongue in dry form or when dispersed in water and tasted within about five minutes of said dispersal. A preferred composition further includes dry-blendedly admixed polyvinylpyrrolidone present in an amount of about 0.5 to about 5 weight percent of the total composition. Flavorants can also be present.

Terfenadine oral granules

The present invention contemplates a dry, powdered terfenadine composition. That composition comprises

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Dracut, MA, United States of America

Abdel A Fawzy