Ascent Pharmaceuticals, Inc.

Ascent Pediatrics, Inc.

Fisons Ltd.

Emmett Clemente

Aloysius O Anaebonam

Robert W Mendes

Abdel A Fawzy

Mumtaz Ahmed

Ho-Leung Fung

Yuppadee Javroongrit

Eric M Morrel

Denise Brousseau

Diane Ringden

Theresa Devlin

Nitin Pathak

An extended release acetaminophen composition comprises particles containing acetaminophen coated on sugar/starch seeds. The particles are present as a blend of both an immediate release and a controlled release form. The composition, 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 a temperature of 37&deg; C., exhibits about 40 percent acetaminophen dissolution at one-half hour, about 55 percent acetaminophen dissolution at one hour, and substantially complete dissolution of acetaminophen at six hours. A process for treating a human patient with the extended release acetaminophen composition is also disclosed.

Extended release acetaminophen

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.

This invention is directed to an aqueous pharmaceutical composition with 1.25 mg to about 10 mg trimethoprim per mL (wt/vol) of solution and a compound of suitable acid strength to permit the dissolving of trimethoprim at the appropriate concentration, with the composition having a pH of less than 6.0. This composition is particularly useful for pediatric oral use.

Palatable trimethoprim oral solution

A process and pharmaceutical composition for the prevention and treatment of cutaneous Type I hypersensitivity reactions in humans is disclosed. The pharmaceutical composition comprises of a chromone compound of the following formula, or a pharmacologically acceptable salt, ester or amide thereof: ##STR1## dissolved or dispersed in a pharmacologically acceptable carrier. In accordance with the process, a preventively or therapeutically effective amount of the composition is topically administered to a human patient, as required; i.e. for prevention the composition is administered to the area of skin susceptible to exposure to antigen and for treatment the composition is administered to the reaction site.

Composition and process for prevention and treatment of cutaneous

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

This invention is directed to pharmaceutical compositions of calcium polycarbophil (CPC) sprinkles. The CPC sprinkles contain very fine calcium polycarbophil powder, with smooth particles, and are processed with one or more excipients to produce a flowable, dispersible composition. For pediatric dosing, the CPC sprinkles are premixed with food and when placed in the mouth, its smooth and creamy consistency makes it easy to ingest without leaving a gritty mouthfeel.

Calcium polycarbophil sprinkle

A process and pharmaceutical composition for treatment of uremic pruritus in humans is disclosed. The pharmaceutical composition comprises of a chromone compound of the following formula, or a pharmacologically acceptable salt, ester or amide thereof: ##STR1## dissolved or dispersed in a pharmacologically acceptable carrier. In accordance with the process, a therapeutically effective amount of the composition is topically administered to a pruritic lesion of a human patient.

Process for treating uremic pruritus

A process and pharmaceutical composition for treatment of hemangioma in humans is disclosed. The pharmaceutical composition comprises a chromone compound of the following formula, or a pharmacologically acceptable salt, ester or amide thereof: ##STR1## dissolved or dispersed in a pharmacologically acceptable carrier. In accordance with the process, a therapeutically effective amount of the composition is topically administered to a hemangioma of a human patient.

Process for treating hemangioma

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

Terfenadine oral powder

A pharmaceutical composition comprising an aqueous solution of pentamidine or a pharmaceutically acceptable salt thereof, the solution having a pH of less than 4.5. The pH of the solution is preferably less than 4.0, more preferably less than 3.5, and especially less than 3.0. Also disclosed is a method for the prophylactic or remedial treatment of pneumo-cystis carinii pneumonia, which method comprises administration by inhalation to a patient having or being susceptible to that condition of a therapeutically effective quantity of an aqueous solution of pentamidine, or a pharmaceutically acceptable salt thereof, the solution having a pH of less than 4.5.

Solutions of pentamidine

There is described an aqueous pharmaceutical solution comprising a steroid selected from prednisolone, prednisolone sodium phosphate, prednisone and methyl prednisolone, the steroid being present at a concentration of at least 0.3 mg/ml., the pH of the formulation between 5 and 8 and the formulation containing a pharmaceutically acceptable preservative, a pharmaceutically acceptable chelating agent, and being substantially free of ethanol. There is also described a method of treatment of a variety of conditions, particularly in children, using the solution.

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Manchester, MA, United States of America

Emmett Clemente