Compositions for topical treatment of radiation dermatitis
Inventors
Sharma, Purnendu Kumar • Mantel, Alon • Manne, Srikanth • Nalamothu, Vijendra • Lalgudi, Ramanathan
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12059393-B2
Publication Date
2024-08-13
Expiration Date
Abstract
The present disclosure relates to topical compositions and methods for the treatment of radiation dermatitis. The compositions include specific formulations of a cannabinoid and olive oil, along with other specified ingredients.
Core Innovation
The disclosed invention relates to a topical composition for the treatment of radiation dermatitis (radiodermatitis) comprising a cannabinoid and olive oil. The composition includes 0.1 wt % to 25 wt % of a cannabinoid and about 20 wt % to 27.75 wt % of olive oil, where the olive oil is modified to comprise at least 0.1 wt % of at least one molecule containing an aliphatic chain with at least one cyclopropyl or cyclopropenyl group.
The cannabinoid is described as a non-psychoactive cannabinoid, particularly cannabidiol (CBD) and cannabidiol derivatives, including CBD acetate and CBD isolate, as well as full-spectrum CBD and broad-spectrum CBD. The composition further defines formulation components and ranges, including 1 wt % to 8 wt % of an emulsifier which is a surfactant, 10 wt % to 15 wt % of diethylene glycol monoethyl ether, 1 wt % to 4 wt % of polysorbate 80, 3 wt % to 5 wt % of a gelling agent, and 3 wt % to 8 wt % of a fatty alcohol, with balance water.
In embodiments described in the partial content, cyclopropene/cyclopropane fatty acids (CPFA) are used, including sterculic acid, malvalic acid, and dihydrosterculic acid. The disclosed content indicates that the modified olive oil and cannabinoid formulation are used to treat radiation dermatitis topically, including evaluation of prototypes for color, stability, and viscosity.
Non-limiting in vitro and mouse study data are described to show that a CBD-in-olive-oil formulation reduces measures of UV/radiation dermatitis, including cytotoxicity assessment and blinded clinical dermatitis scoring, with an observed effect on redness and duration of moderate dermatitis. Prototype formulations are described in topical application formats such as cream, gel, hydrogel, lotion, ointment, and bandage/patch, as well as associated kit formats and treatment schedules.
Claims Coverage
The partial content provides two independent claims, directed to a topical cannabinoid/modified-olive-oil formulation for radiation dermatitis and to a method of treating a patient using that formulation. The inventive features are concentrated in the defined ranges for the cannabinoid and olive oil, the required modification of the olive oil, and the defined formulation component ranges.
Cyclopropyl or cyclopropenyl-modified olive oil in topical radiation dermatitis composition
A topical composition for the treatment of radiation dermatitis comprising about 20 wt % to 27.75 wt % of olive oil, wherein the olive oil is modified to comprise at least 0.1 wt % of at least one molecule containing an aliphatic chain with at least one cyclopropyl or cyclopropenyl group.
Cannabinoid concentration in topical radiation dermatitis composition
A topical composition for the treatment of radiation dermatitis comprising 0.1 wt % to 25 wt % of a cannabinoid.
Defined surfactant, DGME, polysorbate 80, gelling agent, and fatty alcohol ranges
The topical composition further comprises 1 wt % to 8 wt % of an emulsifier which is a surfactant, 10 wt % to 15 wt % of diethylene glycol monoethyl ether, 1 wt % to 4 wt % of polysorbate 80, 3 wt % to 5 wt % of a gelling agent, 3 wt % to 8 wt % of a fatty alcohol, and balance water.
Administering the defined cannabinoid/modified-olive-oil formulation to a radiation dermatitis patient
A method for treating a patient exhibiting radiation dermatitis comprising administering to an area exhibiting radiation dermatitis a formulation comprising a cannabinoid, where the formulation comprises 0.1 wt % to 25 wt % of a cannabinoid, about 20 wt % to 27.75 wt % of olive oil modified to comprise at least 0.1 wt % of at least one molecule containing an aliphatic chain with at least one cyclopropyl or cyclopropenyl group, and the same defined ranges for the emulsifier, diethylene glycol monoethyl ether, polysorbate 80, gelling agent, fatty alcohol, and water.
Overall claim coverage is focused on a defined topical formulation for radiation dermatitis containing a specified range of cannabinoid and a specified range of olive oil, a required modification of the olive oil using cyclopropyl or cyclopropenyl-containing molecules, and defined formulation component ranges. The method claim mirrors these same formulation constraints in the context of administering the formulation to an area exhibiting radiation dermatitis.
Stated Advantages
Reduces UV/radiation dermatitis measures, including redness and blinded clinical dermatitis scoring.
Reduces cell cytotoxicity measures.
Reduces the duration of moderate dermatitis.
Documented Applications
Topical treatment of radiation dermatitis (radiodermatitis) using a cannabinoid formulation with modified olive oil.
Use in topical application formats including cream, gel, hydrogel, lotion, ointment, and bandage/patch.
Use in prototypes and kits associated with topical application and treatment schedules for radiation dermatitis.
Interested in licensing this patent?