MAKE-UP REMOVER WIPE FORMULATIONS
20230277419 · 2023-09-07
Inventors
Cpc classification
A61K8/4953
HUMAN NECESSITIES
A61K8/604
HUMAN NECESSITIES
A61K8/97
HUMAN NECESSITIES
A61K8/735
HUMAN NECESSITIES
International classification
A61K8/97
HUMAN NECESSITIES
Abstract
The present disclosure describes pre-moistened wipes and cleansing formulations and methods for cleansing the eyelid, periocular, and ocular surface tissues. The formulations comprise mixtures of gentle surfactants and naturally -derived ingredients, which provides for effective cleaning of delicate skin while having non-irritating properties.
Claims
1. A wipe for the eye area, comprising a pad which is pre-moistened with a cleansing formulation, wherein the formulation comprises decyl glucoside and/or sorbitan oleate decylglucoside crosspolymer; and a package.
2. The wipe according to claim 1, wherein the formulation is sterilized by filtration, autoclaving, gamma irradiation and/or electron-beam.
3. The wipe according to claim 1, wherein the formulation is free of parabens, thiazolinones, and formaldehyde-donor preservatives.
4. The wipe according to claim 1, wherein the formulation is free of polyethylene glycol (PEG) and PEG-containing ingredients.
5. The wipe according to claim 1, wherein the formulation further comprises at least one natural humectant.
6. The wipe according to claim 5, wherein the at least one natural humectant is chosen from sodium hyaluronate, propanediol, erythritol, and ectoine.
7. The wipe according to claim 1, wherein the formulation further comprises a citrate-phosphate buffer providing the formulation with a pH of 7 - 8.
8. The wipe according to claim 1, wherein the formulation further comprises at least one plant extract.
9. The wipe according to claim 8, wherein the at least one plant extract is chosen from aloe barbadensis leaf juice, licorice root (glycyrrhiza glabra) extract, dandelion root (taraxacum officinale) extract, kelp (ascophyllum nodosum) extract, cucumber fruit (cucumis sativa) extract, eyebright (euphrasia officinalis) extract, caffeine, menthol, and white mulberry (morus alba) bark extract.
10. The wipe according to claim 1, wherein the formulation further comprises at least one vitamin.
11. The wipe according to claim 10, wherein the at least one vitamin is chosen from d-panthenol (pro-vitamin B), tocopherol (vitamin E), sodium ascorbyl phosphate (vitamin C), niacinamide (vitamin B3), d-panthenol (pro-vitamin B5), and d-biotin (vitamin B7).
12. The wipe according to claim 1, wherein the formulation further comprises at least one antimicrobial agent.
13. The wipe according to claim 12, wherein the at least one antimicrobial agent is chosen from caprylyl glycol, phenylpropanol, 1,2-hexanediol, caprylyl glycol, and alexidine chloride.
14. The wipe according to claim 1, wherein the formulation comprises: 0.10 wt% to 0.24 wt% sodium hyaluronate; 0.55 wt% to 1.05 wt% propanediol; 0.08 wt% to 0.20 wt% ectoine; 0.01 wt% to 0.20 wt% d-panthenol (pro-vitamin B5); 0.015 wt% to 0.025 wt% citric acid monohydrate; 0.10 wt% to 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 0.06 wt% to 1.0 wt% decyl glucoside.
15. The wipe according to claim 14, wherein the formulation further comprises: 0.01 wt% to 0.30 wt% erythritol; 0.01 wt% to 0.05 wt% d-biotin (vitamin B7); 0.01 wt% 0.95 wt% niacinamide (vitamin B3); 0.01 wt% to 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.01 wt% to 0.20 wt% sodium chloride; 0.01 wt% to 0.10 wt% potassium chloride; 0.01 wt% to 0.10 wt% sodium phosphate dibasic; 0.01 wt% to 0.10 wt% sodium citrate dihydrate; 0.01 wt% to 0.20 wt% 1,2-hexanediol and caprylyl glycol; 0.01 wt% to 2.0 wt% alexidine chloride, 0.5% solution; 0.01 wt% to 0.20 wt% aloe barbadensis leaf juice (concentrate 200:1); 0.01 wt% to 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin or butylene glycol; 0.01 wt% to 0.20 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.01 wt% to 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.01 wt% to 0.20 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% to 0.20 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.01 wt% to 0.20 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.01 wt% to 0.02 wt% caffeine; and/or 0.01 wt% to 0.02 wt% L-menthol.
16. The wipe according to claim 1, wherein the formulation comprises: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.15 wt% ectoine; 0.15 wt% erythritol; 0.10 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.01 wt% aloe barbadensis leaf juice (concentrate 200:1); 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
17. The wipe according to claim 1, wherein the formulation comprises: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.05 wt% d-panthenol (pro-vitamin B5); 0.05 wt% d-biotin (vitamin B7); 0.10 wt% niacinamide (vitamin B3); 0.05 wt% sodium ascorbyl phosphate (vitamin C); 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% 1,2-hexanediol and caprylyl glycol; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in butylene glycol; 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.05 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
18. The wipe according to claim 1, wherein the formulation comprises: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.05 wt% niacinamide (vitamin B3); 0.10 wt% sodium ascorbyl phosphate (vitamin C); 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.0025 wt% L-menthol; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
19. The wipe according to claim 1, wherein the formulation comprises: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.20 wt% erythritol; 0.20 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.06 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.01 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.18 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.90 wt% sorbitan oleate decylglucoside crosspolymer; and 0.90 wt% decyl glucoside.
20. The wipe according to claim 1, wherein the formulation comprises: 0.18 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.10 wt% ectoine; 0.10 wt% erythritol; 0.15 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.10 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.02 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
21. The wipe according to claim 1, wherein the formulation comprises: 0.24 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% erythritol; 0.15 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.01 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.20 wt% dandelion root (taraxacum officinale) extract in glycerin; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
22. The wipe according to claim 1, wherein the formulation comprises: 0.24 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.15 wt% ectoine; 0.15 wt% erythritol; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
23. The wipe according to claim 1, wherein the formulation comprises: 0.15 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.20 wt% ectoine; 0.30 wt% erythritol; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.10 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.15 wt% dandelion root (taraxacum officinale) extract in glycerin; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
24. The wipe according to claim 1, wherein the formulation comprises: 0.15 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.10 wt% ectoine; 0.20 wt% erythritol; 0.20 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.05 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.65 wt% sorbitan oleate decylglucoside crosspolymer; and 0.85 wt% decyl glucoside.
25. The wipe according to claim 1, wherein the formulation comprises: 0.15 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.80 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.20 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.80 wt% sorbitan oleate decylglucoside crosspolymer; and 0.70 wt% decyl glucoside.
26. The wipe according to claim 1, wherein the formulation comprises: 0.15 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.20 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.05 wt% d-biotin (vitamin B7); 0.10 wt% niacinamide (vitamin B3); 0.05 wt% sodium ascorbyl phosphate (vitamin C); 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% 1,2-hexanediol and caprylyl glycol; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in butylene glycol; 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.15 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% L-menthol; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
27. The wipe according to claim 1, wherein the formulation comprises: 0.15 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.20 wt% ectoine; 0.01 wt% d-panthenol (pro-vitamin B5); 0.05 wt% niacinamide (vitamin B3); 0.10 wt% sodium ascorbyl phosphate (vitamin C); 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.20 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.10 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
28. The wipe according to claim 1, wherein the formulation comprises: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.95 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
29. The wipe according to claim 1, wherein the formulation comprises: 0.18 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.08 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.70 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.20 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
30. The wipe according to claim 1, wherein the formulation comprises: 0.18 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.90 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.15 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.10 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.2 wt% sorbitan oleate decylglucoside crosspolymer; and 0.6 wt% decyl glucoside.
31. The wipe according to claim 1, wherein the formulation comprises: 0.18 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.15 wt% ectoine; 0.08 wt% d-panthenol (pro-vitamin B5); 0.10 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.5 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.02 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.18 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.1 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
32. The wipe according to claim 1, wherein the formulation comprises: 0.1 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.20 wt% ectoine; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.0 wt% alexidine chloride, 0.5% solution; 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.18 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.18 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.2 wt% sorbitan oleate decylglucoside crosspolymer; and 0.6 wt% decyl glucoside.
33. The wipe according to claim 1, wherein the formulation comprises: 0.10 wt% sodium hyaluronate; 0.55 wt% propanediol; 0.12 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.45 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.5 wt% alexidine chloride, 0.5% solution; 0.18 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.3 wt% sorbitan oleate decylglucoside crosspolymer; and 0.06 wt% decyl glucoside.
34. A formulation for cleansing the eye area comprising decyl glucoside and sorbitan oleate decylglucoside crosspolymer.
35. The formulation according to claim 34, which is compatible with sterilization by filtration, autoclaving, gamma irradiation and/or electron-beam.
36. The formulation according to claim 34, which is stable.
37. The formulation according to claim 34, which is free of parabens, thiazolinones, and formaldehyde-donor preservatives.
38. The formulation according to claim 34, which is free of polyethylene glycol (PEG) and PEG-containing ingredients.
39. The formulation according to claim 34, further comprising at least one natural humectant.
40. The formulation according to claim 39, wherein the at least one natural humectant is chosen from sodium hyaluronate, propanediol, erythritol, and ectoine.
41. The formulation according to claim 34, further comprising sodium hyaluronate, propanediol, erythritol, and ectoine.
42. The formulation according to claim 34, further comprising sodium hyaluronate and at least one natural humectant having antioxidant activity.
43. The formulation according to claim 42, wherein the at least one natural humectant having antioxidant activity is chosen from erythritol and ectoine.
44. The formulation according to claim 43, further comprising propanediol.
45. The formulation according to claim 34, further comprising at least one buffer.
46. The formulation according to claim 45, wherein the at least one buffer is chosen from citrate-phosphate buffers.
47. The formulation according to claim 45 46, wherein the at least one buffer provides the formulation with a pH of 6 - 8.
48. The formulation according to claim 34, further comprising at least one plant extract.
49. The formulation according to claim 48, wherein the at least one plant extract is chosen from aloe barbadensis leaf juice, licorice root (glycyrrhiza glabra) extract, dandelion root (taraxacum officinale) extract, cucumber fruit (cucumber sative) extract, kelp (ascophyllum nodosum) extract, eyebright (euphrasia officinalis) extract, caffeine, menthol, and white mulberry (morus alba) bark extract.
50. The formulation according to claim 34, further comprising at least one vitamin.
51. The formulation according to claim 50, wherein the at least one vitamin is chosen from d-panthenol (pro-vitamin B), tocopherol (vitamin E), sodium ascorbyl phosphate (vitamin C), niacinamide (vitamin B3), d-panthenol (pro-vitamin B5), and d-biotin (vitamin B7).
52. The formulation according to claim 34, further comprising phenylethyl resorcinol.
53. The formulation according to claim 34, further comprising at least one antimicrobial agent.
54. The formulation according to claim 53, wherein the at least one antimicrobial agent is chosen from caprylyl glycol, phenylpropanol, 1,2-hexanediol, caprylyl glycol, and alexidine chloride.
55. The formulation according to claim 34, comprising: 0.10 wt% to 0.24 wt% sodium hyaluronate; 0.55 wt% to 1.05 wt% propanediol; 0.08 wt% to 0.20 wt% ectoine; 0.01 wt% to 0.20 wt% d-panthenol (pro-vitamin B5); 0.015 wt% to 0.025 wt% citric acid monohydrate; 0.10 wt% to 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 0.06 wt% to 1.0 wt% decyl glucoside.
56. The formulation according to claim 55, further comprising: 0.01 wt% to 0.30 wt% erythritol; 0.01 wt% to 0.05 wt% d-biotin (vitamin B7); 0.01 wt% 0.95 wt% niacinamide (vitamin B3); 0.01 wt% to 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.01 wt% to 0.20 wt% sodium chloride; 0.01 wt% to 0.10 wt% potassium chloride; 0.01 wt% to 0.10 wt% sodium phosphate dibasic; 0.01 wt% to 0.10 wt% sodium citrate dihydrate; 0.01 wt% to 0.20 wt% 1,2-hexanediol and caprylyl glycol; 0.01 wt% to 2.0 wt% alexidine chloride, 0.5% solution; 0.01 wt% to 0.20 wt% aloe barbadensis leaf juice (concentrate 200:1); 0.01 wt% to 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin or butylene glycol; 0.01 wt% to 0.20 wt% dandelion roon (taraxacum officinale) extract in glycerin; 0.01 wt% to 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.01 wt% to 0.20 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% to 0.20 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.01 wt% to 0.20 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.01 wt% to 0.02 wt% caffeine; and/or 0.01 wt% to 0.02 wt% L-menthol.
57. The formulation according to claim 34, comprising: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.15 wt% ectoine; 0.15 wt% erythritol; 0.10 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.01 wt% aloe barbadensis leaf juice (concentrate 200:1); 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% dandelion roon (taraxacum officinale) extract in glycerin; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
58. The formulation according to claim 34, comprising: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.05 wt% d-panthenol (pro-vitamin B5); 0.05 wt% d-biotin (vitamin B7); 0.10 wt% niacinamide (vitamin B3); 0.05 wt% sodium ascorbyl phosphate (vitamin C); 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% 1,2-hexanediol and caprylyl glycol; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in butylene glycol; 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.05 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
59. The formulation according to claim 34, comprising: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.05 wt% niacinamide (vitamin B3); 0.10 wt% sodium ascorbyl phosphate (vitamin C); 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.0025 wt% L-menthol; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
60. The formulation according to claim 34, comprising: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.20 wt% erythritol; 0.20 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.06 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.01 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.18 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.90 wt% sorbitan oleate decylglucoside crosspolymer; and 0.90 wt% decyl glucoside.
61. The formulation according to claim 34, comprising: 0.18 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.10 wt% ectoine; 0.10 wt% erythritol; 0.15 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.10 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.02 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
62. The formulation according to claim 34, comprising: 0.24 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% erythritol; 0.15 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.01 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.20 wt% dandelion root (taraxacum officinale) extract in glycerin; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
63. The formulation according to claim 34, comprising: 0.24 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.15 wt% ectoine; 0.15 wt% erythritol; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
64. The formulation according to claim 34, comprising: 0.15 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.20 wt% ectoine; 0.30 wt% erythritol; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% sodium chloride; 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.10 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.15 wt% dandelion root (taraxacum officinale) extract in glycerin; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
65. The formulation according to claim 34, comprising: 0.15 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.10 wt% ectoine; 0.20 wt% erythritol; 0.20 wt% d-panthenol (pro-vitamin B5); 0.15 wt% sodium chloride; 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.05 wt% aloe barcadensis leaf juice (concentrate 200:1); 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% dandelion root (taraxacum officinale) extract in glycerin; 0.65 wt% sorbitan oleate decylglucoside crosspolymer; and 0.85 wt% decyl glucoside.
66. The formulation according to claim 34, comprising: 0.15 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.80 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.20 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.80 wt% sorbitan oleate decylglucoside crosspolymer; and 0.70 wt% decyl glucoside.
67. The formulation according to claim 34, comprising: 0.15 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.20 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.05 wt% d-biotin (vitamin B7); 0.10 wt% niacinamide (vitamin B3); 0.05 wt% sodium ascorbyl phosphate (vitamin C); 0.10 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.015 wt% citric acid monohydrate; 0.20 wt% 1,2-hexanediol and caprylyl glycol; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in butylene glycol; 0.10 wt% white mulberry (morus alba) bark extract in butylene glycol; 0.15 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% L-menthol; 1.0 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
68. The formulation according to claim 34, comprising: 0.15 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.20 wt% ectoine; 0.01 wt% d-panthenol (pro-vitamin B5); 0.05 wt% niacinamide (vitamin B3); 0.10 wt% sodium ascorbyl phosphate (vitamin C); 0.05 wt% potassium chloride; 0.10 wt% sodium phosphate dibasic; 0.10 wt% sodium citrate dihydrate; 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.20 wt% kelp (ascophyllum nodosum) extract in butylene glycol; 0.10 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.02 wt% caffeine; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
69. The formulation according to claim 34, comprising: 0.12 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.20 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.95 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.05 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.75 wt% sorbitan oleate decylglucoside crosspolymer; and 0.75 wt% decyl glucoside.
70. The formulation according to claim 34, comprising: 0.18 wt% sodium hyaluronate; 0.60 wt% propanediol; 0.08 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.70 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 2.0 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.05 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.20 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.5 wt% sorbitan oleate decylglucoside crosspolymer; and 0.5 wt% decyl glucoside.
71. The formulation according to claim 34, comprising: 0.18 wt% sodium hyaluronate; 0.80 wt% propanediol; 0.10 wt% ectoine; 0.15 wt% d-panthenol (pro-vitamin B5); 0.90 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.0 wt% alexidine chloride, 0.5% solution; 0.10 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.15 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.10 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.2 wt% sorbitan oleate decylglucoside crosspolymer; and 0.6 wt% decyl glucoside.
72. The formulation according to claim 34, comprising: 0.18 wt% sodium hyaluronate; 1.05 wt% propanediol; 0.15 wt% ectoine; 0.08 wt% d-panthenol (pro-vitamin B5); 0.10 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.5 wt% alexidine chloride, 0.5% solution; 0.15 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.02 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.18 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.1 wt% sorbitan oleate decylglucoside crosspolymer; and 1.0 wt% decyl glucoside.
73. The formulation according to claim 34, comprising: 0.1 wt% sodium hyaluronate; 0.75 wt% propanediol; 0.20 wt% ectoine; 0.05 wt% d-panthenol (pro-vitamin B5); 0.20 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.0 wt% alexidine chloride, 0.5% solution; 0.20 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.18 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.18 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.2 wt% sorbitan oleate decylglucoside crosspolymer; and 0.6 wt% decyl glucoside.
74. The formulation according to claim 34, comprising: 0.10 wt% sodium hyaluronate; 0.55 wt% propanediol; 0.12 wt% ectoine; 0.10 wt% d-panthenol (pro-vitamin B5); 0.45 wt% niacinamide (vitamin B3); 0.20 wt% sodium ascorbyl phosphate (vitamin C); 0.025 wt% citric acid monohydrate; 1.5 wt% alexidine chloride, 0.5% solution; 0.18 wt% licorice root (glycyrrhiza glabra) extract in glycerin; 0.10 wt% cucumber fruit (cucumis sative) extract in glycerin; 0.01 wt% eyebright (euphrasia officinalis) extract in glycerin; 0.3 wt% sorbitan oleate decylglucoside crosspolymer; and 0.06 wt% decyl glucoside.
75. The formulation according to claim 34, wherein the formulation is stable.
76. The formulation according to claim 34, wherein the formulation is shelf-stable.
77. The formulation according to claim 34, wherein, the pH of the formulation after storage at 20-25° C. for 24 months, is not more than 0.75 pH, such as not more than 0.6 pH units, not more than 0.5 pH units, not more than 0.4 pH units, not more than 0.3 pH units, not more than 0.2 pH units, not more than 0.1 pH units, of the pH of the formulation prior to the storage.
78. The formulation according to claim 34, wherein the osmolality of the formulation after storage at 20-25° C. for 24 months is within 40 mOsm, such as within 35 mOsm, within 30 mOsm, within 25 mOsm, within 20 mOsm, within 15 mOsm, within 10 mOsm, within 5 mOsm, or within 1 mOsm of the osmolality of the formulation prior to the storage.
79. The wipe according to claim 1, wherein the formulation is stable.
80. The wipe according to claim 1, wherein the formulation is shelf-stable.
81. The wipe according to claim 1, wherein the pH of the formulation after storage at 20-25° C. for 24 months, is not more than 0.75 pH, such as not more than 0.6 pH units, not more than 0.5 pH units, not more than 0.4 pH units, not more than 0.3 pH units, not more than 0.2 pH units, not more than 0.1 pH units, of the pH of the formulation prior to the storage.
82. The wipe according to claim 1, wherein the osmolality of the formulation after storage at 20-25° C. for 24 months is within 40 mOsm, such as within 35 mOsm, within 30 mOsm, within 25 mOsm, within 20 mOsm, within 15 mOsm, within 10 mOsm, within 5 mOsm, or within 1 mOsm of the osmolality of the formulation prior to the storage.
Description
PROPHETIC EXAMPLES
[0062] Formulations of the present disclosure can be prepared with ingredients as listed in the following tables.
TABLE-US-00001 Formulation component Ingredient Formulation (Wt%) A B C D E F G H I Polymers /Viscosity-increasing Agent Sodium Hyaluronate 0.12 0.12 0.12 0.12 0.18 0.24 0.24 0.15 0.15 Humectants Propanediol 0.80 0.80 0.80 0.80 0.60 0.80 1.05 0.75 0.75 Glycerin (in extracts) -- (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) Butylene glycol -- (in extracts) -- -- -- -- -- -- -- Ectoine 0.15 0.20 0.20 0.20 0.10 0.10 0.15 0.20 0.10 Erythritol 0.15 0.20 0.10 0.15 0.15 0.30 0.20 Vitamins d-panthenol (pro-vitamin B5) 0.10 0.05 0.10 0.20 0.15 0.15 0.05 0.05 0.20 d-Biotin (Vitamin B7) -- 0.05 -- -- -- -- -- -- -- Niacinamide (Vitamin B3) -- 0.10 0.05 0 -- -- -- -- -- Sodium ascorbyl phosphate (Vitamin C) -- 0.05 0.10 -- -- -- -- -- -- Salts /Electrolytes Sodium Chloride 0.15 -- -- 0.15 0.20 0.20 0.20 0.20 0.15 Potassium Chloride 0.10 0.10 0.05 0.10 0.05 0.05 0.05 0.05 0.10 Sodium phosphate dibasic, anhydrous 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 Sodium citrate, dihydrate 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 Citric acid, monohydrate 0.015 0.015 0.025 0.015 0.015 0.015 0.015 0.015 0.015 Antimicrobial Agents 1,2-hexanediol (and) caprylyl glycol -- 0.20 -- -- -- -- -- -- -- Alexidine chloride, 0.5% solution -- 2.0 2.0 -- -- -- -- -- -- Plant Extracts Aloe Barbadensis Leaf Juice (concentrate 200:1) 0.01 -- -- 0.06 0.10 0.01 0.20 0.10 0.05 Licorice root (Glycyrrhiza glabra) extract in glycerin 0.10 -- 0.10 0.01 0.15 0.10 0.15 0.20 0.15 Dandelion Root (taraxacum officinale) extract in glycerin 0.05 -- -- 0.18 0.02 0.20 0.05 0.15 0.10 Licorice root (Glycyrrhiza glabra) extract in butylene glycol -- 0.10 -- -- -- -- -- -- -- White mulberry (Morus alba) bark extract in butylene glycol -- 0.10 -- -- -- -- -- -- -- Cucumber Fruit (Cucumis Sative) Extract in glycerin -- -- 0.10 -- -- -- -- -- -- Kelp (Ascophyllum Nodosum) Extract in butylene glycol -- 0.05 0.05 -- -- -- -- -- -- Eyebright (Euphrasia Officinalis) Extract in glycerin -- 0.05 0.05 -- -- -- -- -- -- L-menthol -- -- 0.0025 -- -- -- -- -- -- Caffeine -- 0.02 0.02 -- -- -- -- -- -- Non-ionic Surfactants /Micellar Cleansers Sorbitan Oleate Decylglucoside Crosspolymer 0.75 0.75 0.75 0.90 0.5 1.0 0.5 1.0 0.65 Decyl glucoside 0.75 0.75 0.75 0.90 0.5 1.0 1.0 0.5 0.85
TABLE-US-00002 Formulation component Ingredient Formulation (Wt%) J K L M N O P Q R Polymers /Viscosity-increasing Agent Sodium Hyaluronate 0.15 0.15 0.15 0.12 0.18 0.18 0.18 0.15 0.10 Humectants Propanediol 0.80 0.60 1.05 0.80 0.60 0.80 1.05 0.75 0.55 Glycerin (in extracts) -- (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) (in extracts) Butylene glycol -- (in extracts) -- -- -- -- -- -- -- Ectoine 0.10 0.20 0.20 0.20 0.08 0.10 0.15 0.20 0.12 Erythritol -- -- -- -- -- -- -- -- -- Vitamins d-panthenol (pro-vitamin B5) 0.15 0.15 0.01 0.10 0.10 0.15 0.08 0.05 0.10 d-Biotin (Vitamin B7) -- 0.05 -- -- -- -- -- -- -- Niacinamide (Vitamin B3) 0.80 0.10 0.05 0.95 0.70 0.90 0.10 0.20 0.45 Sodium ascorbyl phosphate (Vitamin C) 0.20 0.05 0.10 0.20 0.20 0.20 0.20 0.20 0.20 Salts /Electrolytes Sodium Chloride -- -- -- -- -- -- -- -- -- Potassium Chloride -- 0.10 0.05 -- -- -- -- -- -- Sodium phosphate -- 0.10 0.10 -- -- -- -- -- -- dibasic, anhydrous Sodium citrate, dihydrate -- 0.10 0.10 -- -- -- -- -- -- Citric acid, monohydrate 0.025 0.015 0.025 0.025 0.025 0.025 0.025 0.025 0.025 Antimicrobial Agents 1,2-hexanediol (and) caprylyl glycol -- 0.20 -- -- -- -- -- -- -- Alexidine chloride, 0.5% solution 2.0 2.0 2.0 2.0 2.0 1.0 1.5 1.0 1.5 Plant Extracts Aloe Barbadensis Leaf Juice (concentrate 200:1) -- -- -- -- -- -- -- -- -- Licorice root (Glycyrrhiza glabra) extract in glycerin 0.15 -- 0.10 0.10 0.15 0.10 0.15 0.20 0.18 Dandelion Root (taraxacum officinale) extract in glycerin -- -- -- -- -- -- -- -- -- Licorice root (Glycyrrhiza glabra) extract in butylene glycol -- 0.10 -- -- -- -- -- -- -- White mulberry (Morus alba) bark extract in butylene glycol -- 0.10 -- -- -- -- -- -- -- Cucumber Fruit (Cucumis Sative) Extract in glycerin 0.20 0.15 0.10 0.10 0.05 0.15 0.02 0.18 0.10 Kelp (Ascophyllum Nodosum) Extract in butylene glycol -- -- 0.20 -- -- -- -- -- -- Eyebright (Euphrasia Officinalis) Extract in glycerin 0.05 0.01 0.10 0.05 0.20 0.10 0.18 0.18 0.01 L-menthol -- 0.02 -- -- -- -- -- -- -- Caffeine -- -- 0.02 -- -- -- -- -- --- Non-ionic Surfactants /Micellar Cleansers Sorbitan Oleate Decylglucoside Crosspolymer 0.80 1.0 0.75 0.75 0.5 0.2 0.1 0.2 0.3 Decyl glucoside 0.70 1.0 1.0 0.75 0.5 0.6 1.0 0.6 0.06
[0063] Formulations with the ingredients listed above can be prepared by mixing the recited ingredients, for example according to the proposed manufacturing process below: [0064] 1. Add water as 90% of batch weight to vessel. [0065] 2. Initiate mixing, for example at 700 rpm for lab mixer. [0066] 3. Disperse sodium hyaluronate into water. [0067] 4. Add pH-adjusting agents (e.g., add sodium citrate, sodium phosphate dibasic, citric acid, sodium ascorbyl phosphate). [0068] 5. Add (in any order, excluding optional ingredients as appropriate): [0069] a. Potassium chloride [0070] b. Ectoine [0071] c. Propanediol [0072] d. Menthol [0073] e. Panthenol [0074] f. Biotin [0075] g. Niacinamide [0076] h. Caffeine [0077] i. Licorice root extract [0078] j. Kelp extract [0079] k. Mulberry extract [0080] l. Eyebright extract [0081] m. Cucumber extract [0082] n. Preservative [0083] 6. Continue mixing for NLT 1 hour. [0084] 7. Reduce mixing speed, for example to 400 rpm for lab mixer. [0085] 8. Add decyl glucoside surfactant. [0086] 9. Add sugamulse D9 surfactant. [0087] 10. Check pH. If necessary, adjust pH with sodium hydroxide and/or hydrochloric acid to pH 7.5 +/- 0.1. [0088] 11. Add water to final batch weight. [0089] 12. (optional) Filter through 0.2-micron or 0.45-micron filter to reduce bioburden, if necessary. [0090] 13. If a sterile product is required, the product may be sterilized by gamma irradiation or autoclaving after packaging, or the product may be aseptically packaged after filtration by a 0.2-micron sterilizing filter.
[0091] The pH, osmolality, and color of the formulations are assessed.
[0092] Formulations listed above can be sterilized by autoclaving at 124° C. for 30 minutes. Once the autoclaved formulated solutions are cooled, the following steps are carried out: [0093] 1. Solution pH is measured to ensure that there is no more than 0.25 pH units change in pH. [0094] 2. Osmolality of the solution is measured to ensure that there is no more than 15 mOsm change in osmolality. [0095] 3. Color of the solution is evaluated to ensure that there is no visible darkening of the solution.
[0096] Autoclaved formulations not able to meet these criteria are deemed unstable and may be deemed unsuitable for use.
[0097] Formulations listed above can alternatively be sterilized by irradiating with gamma irradiation at 20 kGy - 40 kGy. Following irradiation, the following steps are carried out: [0098] 4. Solution pH is measured to ensure that there is no more than 0.25 pH units change in pH. [0099] 5. Osmolality of the solution is measured to ensure that there is no more than 15 mOsm, change in osmolality. [0100] 6. Color of the solution is evaluated to ensure that there is no visible darkening of the solution.
[0101] Irradiated formulations not able to meet these criteria are deemed unstable and may be deemed unsuitable for use
[0102] Batches of Formulation A were manufactured under representative conditions and sterilized at low-dose gamma irradiation (19-26 kGy) and high-dose gamma irradiation (40-50 kGy) and then stability was assessed.
TABLE-US-00003 Dose T=0 3 M/25° C. 1 M/40° C. 2 M/40° C. 3 M/40° C. 40-50 kGy pH 7.4 7.37 7.41 7.64 7.38 Osmolality 322 323 340 282 322 Sterility pass n/a n/a n/a n/a Weight Loss % n/a -0.20 -0.20 0.00 -0.14 19-26 kGy pH 7.5 7.36 7.31 7.91 7.36 Osmolality 338 326 398 338 327 Sterility pass n/a n/a n/a n/a Weight Loss n/a -0.20 3.00 -0.07 -0.16 19-26 kGy pH 7.6 7.43 7.43 7.68 7.40 Osmolality 324 307 282 288 308 Sterility pass n/a n/a n/a n/a Weight Loss n/a -0.17 -0.20 -0.05 -0.19 19-26 kGy pH 7.4 6.98 7.08 7.11 6.99 Osmolality 308 302 328 278 302 Sterility pass n/a n/a n/a n/a Weight Loss n/a -0.18 -1.20 -0.14 -0.18