TREATMENT AND PROPHYLAXIS OF RADIATION DERMATITIS

• US 20160015752A1
• Filed: 03/06/2014
• Published: 01/21/2016
• Est. Priority Date: 03/06/2013
• Status: Active Grant

• Current Assignee: Radiaderm Limited
• Original Assignee: Water-Jel Europe Llp
• Inventors: LAIT, Mark, BISHOP, George
• Granted Patent: US 10,098,912 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 31/12 Ketones
• CPC Class Codes: A61K 31/133 having hydroxy groups, e.g. sphingosine
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/275 Nitriles; Isonitriles
• CPC Class Codes: A61K 35/20 Milk; Whey; Colostrum
• CPC Class Codes: A61K 38/018 from milk
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/46 Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders

Abstract

The present disclosure relates to topical formulations comprising purified water, milk protein fluid and thickener, in particular a hydrogel and a lotion, and their use in treatment of radiation dermatitis, in particular in a two-step process for the treatment of radiation dermatitis.

Claims

1. A topical formulation for the prophylaxis and/or treatment of radiation dermatitis comprising purified water, milk protein fluid and thickener.

2. A topical formulation according to claim 1 wherein the viscosity is in the range 25,000 CPS to 510,000 CPS, for example 25,000 CPS to 130,000 CPS or 290,000 CPS to 510,000 CPS.

3. A topical formulation according to claim 1 comprising 4-8% milk protein, for example wherein the milk protein fluid is lactokine.

4. A topical formulation according to claim 1 further comprising a preservative, for example 0.5-1.2% preservative, such as phenoxyethanol and ethylhexylglycerine.

5. A topical formulation according to claim 1 further comprising up to 1% chelating agent, such as edetate disodium.

6. A topical formulation according to claim 1 wherein the formulation is a hydrogel further comprising one or more ingredients selected from:

carbomer such as carbomer 940 and/or carbomer T1, pH modifier such as trolamine, and moisturising agent such a glycerine.

7. A hydrogel according to claim 6 consisting essentially of:

89-93.5% purified water,

4-8% milk protein fluid,

0.5-1.15% glycerine,

0.1-3.5% trolamine,

0.5-1.2% preservative,

0.1-0.9% carbomer,

0.25-0.85% thickener, and

0-1% edetate disodium.

8. A hydrogel according to claim 6 wherein the thickener is acrylate/Cio-30 acrylate crosspolymer.

9. A hydrogel according to claim 6 consisting essentially of:

91.15% purified water,

5% lactokine,

1% glycerine,

0.8% trolamine,

0.75% phenoxyethanol and ethylhexylglycerine,

0.4% carbomer 940,

0.3% carbomer TR1,

0.5% acrylate/C_10-30 alkyl acrylate crosspolymer, and

0.1% edetate disodium

and wherein the viscosity is in the range 290,000 to 510,000 cP.

10. A hydrogel according to claim 6 wherein the hydrogel has high thermal capacity.

11. A topical formulation according to claim 1 wherein the formulation is a lotion further comprising one or more ingredients selected from:

non-metallic UVA and/or UVB inhibitor such as octocrylene, octinoxate, homosalate or avobenzone or a mixture thereof,

C_12-15 alkyl benzoate,

caprylyl methicone,

emulsifier such as ceteareth-20 and ceteryl alcohol,

gelling agent such as ammonium acrylolydimethyltaurate/VP copolymer,

glyceryl monostearate such as glyceryl stearate SE and/or glyceryl stearate, and glyceryl stearate citrate.

12. A lotion according to claim 11 consisting essentially of:

7-19% non-metallic UVA and/or UVB inhibitor,

54.5-65.5% purified water,

6-15% C_12-15 alkyl benzoate,

4-8% milk protein fluid,

1-5% caprylyl methicone,

1-2.5% emulsifier,

0.25-1.25% gelling agent,

1-2.5% glyceryl monostearate,

1-2.5% glyceryl stearate citrate,

0.5-1.2% preservative,

0-1% edetate disodium, and

2% thickener.

13. A lotion according to claim 11 wherein the non-metallic UVA and/or UVB inhibitors are octocrylene, octinoxate and avobenzone.

14. A lotion according to claim 11 wherein the thickener is corn starch.

15. A lotion according to claim 11 consisting essentially of:

10% octocrylene,

3% octinoxate,

3% avobenzone,

58.8% purified water,

8% C₁₂-₁₅ alkyl benzoate,

5% lactokine,

4% caprylyl methicone,

1% ceteareth-20 and ceteryl alcohol,

0.7% ammonium acrylolydimethyltaurate/VP copolymer,

1% glyceryl stearate SE,

1.2% glyceryl stearate,

1% glyceryl stearate citrate,

1% phenoxyethanol and ethylhexylglycerine,

0.2% edetate disodium, and

2% corn starch

and wherein the viscosity is in the range 25,000 to 130,000 cP.

16. A two-step process for the prophylaxis and/or treatment of radiation dermatitis comprising the steps:

a) applying a generous layer of the hydrogel of claim 6 to unbroken skin following radiation therapy and leaving it on the skin for at least 20 minutes;

b) applying the lotion of claim 11 unbroken skin to provide moisturisation;

wherein step b) is repeated as often as desired to relieve discomfort.

17. A kit of parts comprising at least one application of the hydrogel formulation of claim 6.

18. A method of prophylaxis and/or treatment for radiation dermatitis comprising administering to patient in need thereof the hydrogel of claim 6.