Ascent Pharmaceuticals, Inc.

Ascent Pediatrics, Inc.

Robert W Mendes

Emmett Clemente

Aloysius O Anaebonam

Mumtaz Ahmed

Abdel A Fawzy

S Esmail Tabibi

Nitin P Pathak

Yuppadee Javroongrit

Eric M Morrel

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

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

A controlled release aqueous emulsion is disclosed, as are its method of manufacture and use as a vehicle for delivering medicaments in liquid form. A contemplated emulsion comprises an oil-in-water emulsion having an average oil particle size of about 100 nm to about 250 nm, a pH value of about 4.5 to about 8.0 and a viscosity at 20.degree.-25.degree. C. of 1 to about 1000 cps. The water phase constitutes at least 25 weight percent of the total composition. The oil phase is a wax matrix that is a wax having a melting point of about 40.degree. to about 80.degree. C. and is present in an amount of about 3 to about 30 percent of the total composition. A pharmaceutically effective amount of a pharmacologically active compound that is free from decomposition at a temperature below about 90.degree. C. is dissolved or dispersed in the wax matrix. The oil and water phases are emulsified by an emulsifying agent that provides freedom from phase separation at a pH value of about 4.5 to about 8, while also providing phase separation at a pH value below about 2.0. The emulsifier, based on lecithin, is present at about 2 to about 20 weight percent of the total composition. The composition can also contain zero to about 35 weight percent additional excipient.

Controlled release aqueous emulsion

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.

Growing community of inventors

Dedham, MA, United States of America

Robert W Mendes