Topical tranexamic acid compositions and methods of use thereof
Inventors
Agha, Bushra • Schoelzel, Douglas Edward
Assignees
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Publication Number
US-11642324-B1
Publication Date
2023-05-09
Expiration Date
Abstract
The present disclosure relates to pharmaceutical compositions of tranexamic acid and methods of using the compositions. The pharmaceutical compositions of the present disclosure are stable and suitable for topical application.
Core Innovation
The invention relates to a topical aqueous composition for reducing bleeding. The composition includes tranexamic acid at a concentration of about 200 mg/mL to about 350 mg/mL and hydroxyethyl cellulose. The topical composition has a viscosity of about 1 to 50 cps, measured at 21°C using a rotational viscosity method, and the hydroxyethyl cellulose has a viscosity of about 800 cps to about 6500 cps as determined in a 2% aqueous solution of the hydroxyethyl cellulose at 20°C.
In one aspect, the invention provides a sterile topical aqueous composition for reducing bleeding. This sterile composition includes tranexamic acid at a concentration of about 200 mg/mL to about 350 mg/mL and hydroxyethyl cellulose having a viscosity of about 800 cps to about 6500 cps as determined in a 2% aqueous solution at 20°C. The sterile composition further includes a pH buffer agent, where the topical composition has a viscosity of about 1 to 50 cps and a pH of about 3 to 5.
The disclosed formulations are described as having controlled pH and viscosity characteristics together with hydroxyethyl cellulose as a viscosity-modifying agent. The patent text further describes pH control agents such as sodium citrate and citric acid to achieve a target pH, and example formulations in an aqueous vehicle with pH adjustment to about 4 and viscosity measured at 21°C.
Claims Coverage
The independent claims cover two core compositions: a topical aqueous composition for reducing bleeding and a sterile topical aqueous composition for reducing bleeding. Across the independent claims, there are four main inventive feature groups.
Topical aqueous tranexamic acid with hydroxyethyl cellulose viscosity and controlled finished viscosity and pH
A topical aqueous composition for reducing bleeding comprising tranexamic acid at a concentration of about 200 mg/mL to about 350 mg/mL and hydroxyethyl cellulose, wherein the topical composition has a viscosity of about 1 to 50 cps measured at 21°C using a rotational viscosity method, the hydroxyethyl cellulose has a viscosity of about 800 cps to about 6500 cps as determined in a 2% aqueous solution of the hydroxyethyl cellulose at 20°C, and the topical composition has a pH of about 3 to 5.
Sterile topical aqueous tranexamic acid with hydroxyethyl cellulose viscosity, pH buffer agent, and controlled finished viscosity and pH
A sterile topical aqueous composition for reducing bleeding comprising tranexamic acid at a concentration of about 200 mg/mL to about 350 mg/mL, hydroxyethyl cellulose having a viscosity of about 800 cps to about 6500 cps as determined in a 2% aqueous solution of the hydroxyethyl cellulose at 20°C, and a pH buffer agent, wherein the topical composition has a viscosity of about 1 to 50 cps and a pH of about 3 to 5.
The claims coverage is focused on topical and sterile aqueous tranexamic acid compositions reduced to specific viscosity and pH constraints, tied to hydroxyethyl cellulose defined by its viscosity in a 2% aqueous solution at 20°C, and to a finished composition viscosity measured at 21°C by a rotational viscosity method.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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