SKIN CARE FORMULATION

Abstract

There is provided a skin care formulation for transdermal administration of a component of a blood product, the formulation comprising a blood product, a transdermal carrier; and a liposomal base, wherein at least a portion of the blood product and transdermal carrier is contained within liposomes of the liposomal base.

Claims

1. A skin care formulation for transdermal administration of a component of a blood product, the formulation comprising: a blood product; a transdermal carrier; and a liposomal base; wherein at least a portion of the blood product and transdermal carrier is contained within liposomes of the liposomal base.

2. The formulation of claim 1 in a nasal dosage form or an oral dosage form selected from the group consisting of a sublingual troche, tablet, wafer, lozenge, buccal troche, tablet, wafer, lozenge, and orally disintegrating tablet.

3. The formulation of claim 1 wherein the blood product is selected from the group consisting of plasma, serum, platelet rich plasma, conditioned plasma and combinations thereof.

4. The formulation of claim 3 wherein the blood product is a human blood product.

5. The formulation of claim 1 wherein the blood product is present in an amount of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, or 80%.

6. The formulation of claim 1 wherein the blood product includes a component selected from the group consisting of growth factor, cytokine, hormone, vitamin, cell, cell fragment, and combination thereof.

7. The formulation of claim 6 wherein the growth factor is selected from the group consisting of endothelial growth factor (EGF), hepatocyte growth factor (HGF), basic fibroblast growth factor (bFGF), granulocyte colony-stimulating factor (G-CSF), vascular endothelial growth factor (VEGF), transforming growth factor alpha (TGF-α), TGF-β1, TGF-β2, TGF-β3, platelet-derived growth factor (PDGF)-AA, PDGF-AB, PDGF-BB, insulin-like growth factor-1 (IGF-1), BMP, BDNF, EGF, HGF,PDGF, FGF, PGF, GDF-8, NGF, Epo, TPO, TCGF, IGF-I, IGF-II, KGF, VEGF, and any combination thereof.

8. The formulation of claim 6 wherein the cytokine is selected from the group consisting of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-1α, IL-1β, IL-2, IL-2R, IL-3, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-12, IL-12, p40/p70, IL-13, IL-14, IL-15, IL-17, tumour necrosis factor (TNF)α, TNF-β, interferon (IFN)-α, INF-β, INF-γ, IL-1RA, IL-4, IL-5, IL-10, IL-13, IFNα, and any combination thereof.

9. The formulation of claim 6 wherein the hormone is selected from the group consisting of epinephrine, melatonin, triiodothyronine, thyroxine, prostaglandin, leukotriene, prostacyclin, thromboxane, amylin, anti-mullerian hormone, adiponectin, angiotensinogen, angiotensin, vasopressin, atrial natriuretic peptide, brain natriuretic peptide, calcitonin, cholecystokin, corticotropin-releasing hormone, cortistatin, encephalin, endothelin, erythropoietin, galanin, gastric inhibitory peptide, gastrin, ghrelin, glucagon, glucagon-like-peptide-1, Gonadotropin-releasing hormone, Growth hormone-releasing hormone, hepcidin, human chorionic gonadotropin, human placental lactogen, human growth hormone, Inhibin, Insulin, Insulin-like growth factor, leptin, lipotropin, melanocyte stimulating hormone, motilin, orexin, oxytocin, pancreatic polypeptide, parathyroid hormone, pituitary adenylate cyclase-activating peptide, prolactin, prolactin releasing hormone, relaxin, renin, secretin, somatostatin, thrombopoietin, thyroid-stimulating hormone, vasoactive intestinal peptide, testosterone, dehydroepiandrosterone, androstenedione, dihydrotestosterone, aldosterone, estradiol, estrone, estriol, cortisol, progesterone, calcitriol, calcidiol, and any combination thereof.

10. The formulation of claim 6 wherein the component is present in an amount from about 0.1-1000 pg/ml, about 1-1000 pg/ml, about 50-1000 pg/ml, about 100-1000 pg/ml, about 200-1000 pg/ml, about 300-1000 pg/ml, about 400-1000 pg/ml, about 500-1000 pg/ml, about 600-1000 pg/ml, about 700-1000 pg/mL, about 800-1000 pg/mL, about 900-1000 pg/mL, about 1 -100 ng/ml, about 10-100 ng/ml, about 10-100 ng/ml, about 20-100 ng/ml, about 30-100 ng/ml, about 40-100 ng/ml, about 50-100 ng/ml, about 60-100 ng/ml, about 170-100 ng/ml, about 80-100 ng/ml, about 90-100 ng/ml, or at least about 100 ng/ml.

11. The formulation of claim 1 wherein the blood product is lyophilized or freeze-dried.

12. The formulation of claim 1 wherein the transdermal carrier is selected from the group consisting of isopropyl alcohol, dipropylene glycol methyl-ether, butylated hydroxytoluene dipropylene glycol monomethyl-ether, 1-methoxy 2-propanol (glysolv PM/Icinol PM), Ethylene glycol monobutylether (butyl glyxolv/butyl icinol), Butyl di glysolv (butyl-icinol), Transcutol, propylene glycol (PG), N-methyl-2 pyrrolidone (NMP), methylene chloride, diethyl ether, ethanol, acetonitrile, ethyl acetate, benzyl alcohol, a combination of natural oil; ethylene glycol, propylene glycol, dimethyl polysiloxane (DMPX), oleic acid, caprylic acid, 1-octanol, ethanol (denatured or anhydrous), liposomal compositions, suitable plant oils, such as Aloe vera derivatives or sesame seed oil or derivatives thereof, acrylic polymers, rubber-based polymers, polysiloxane-based polymers, polyvinylpyrrolidone-based polymers, dimethylsulfoxide (DMSO), dimethylformamide (DMF), lecithin, vesicular aggregates, ethosomes, azone, castor oil derivatives, such as ethoxylated castor oil, jojoba oil derivatives, corn oil derivatives, propylene glycol, and emu oil derivatives.

13. The formulation of claim 1 wherein the transdermal carrier is present in an amount of 1% (w/w) 2% (w/w), 3% (w/w), 4% (w/w), 5% (w/w), or 6%, 7% (w/w), 8% (w/w), 9% (w/w), 10% (w/w), 11% (w/w), 12% (w/w), 13% (w/w), 14% (w/w), 15% (w/w), 16% (w/w), 17% (w/w), 18% (w/w), 19% (w/w), 20% (w/w), 21% (w/w), 22% (w/w), 23% (w/w), 24% (w/w), 25% (w/w), 26% (w/w), 27% (w/w), 28% (w/w), 29% (w/w), 30% (w/w), 29% (w/w), 30% (w/w), 31% (w/w), 32% (w/w), 33% (w/w), 34% (w/w), 35% (w/w), 36% (w/w), 37% (w/w), 38% (w/w), 39% (w/w), 40% (w/w), 41% (w/w), 42% (w/w), 43% (w/w), 44% (w/w), 45% (w/w), 46% (w/w), 47% (w/w), 48% (w/w), 49% (w/w), or 50% (w/w).

14. The formulation of claim 1 wherein the liposomal base is a mixture of about 60-80% wt/wt water, glycerin, C.sub.12-15 alkyl benzoate, glyceryl stearate, dimethicone, cetearyl alcohol, cetearyl glucoside, polyacrylamide, cetyl alcohol, magnesium aluminum silicate, xanthan gum, aloe vera, tocopheryl acetate, prunus amygadalus amara kernel oil, vitis vinifera seed extract, triticum vulgare germ oil, retinyl palmitate, ascorbyl palmitate, Pro-Lipo Multi-emulsion Liposomic System, tetrasodium EDTA, phenoxyethanol, and sodium hydroxymethylglycinate.

15. The formulation of claim 1 further comprising a transdermal enhancer selected from the group consisting of ethyl alcohol, isopropyl alcohol, butyl alcohol, benzyl alcohol, ethylene glycol, diethylene glycol, propylene glycol, dipropylene glycol trimethylene glycol, glycerin, sorbitol, polyethylene glycol, polyoxyethylene-4-lauryl ether, polyoxyethylene-2-oleyl ether, polyoxyethylene-10-oleylether, cotton seed oil, corn oil, safflower oil, olive oil, castor oil, squalene, lanolin; propyl oleate, decyl oleate, isopropyl palmitate, glycol palmitate, glycol laurate, dodecyl myristate, isopropyl myristate, glycol stearate, oleyl alcohol, oleamide, dimethyldecylphosphoxide, methyloctylsulfoxide, dimethyllaurylamide, dodecylpyrrolidone, isosorbitol, dimethylacetonide, dimethylsulfoxide, decylmethylsulfoxide, dimethylformamide; salicylic acid; benzyl nicotinate; lauryl sulfate, sorbitol, polysorbate, linoleic acid, triacetin, ascorbic acid, panthenol, butylated hydroxytoluene, tocopherol, tocopherol acetate, and tocopheryl linoleate.

16. The formulation of claim 1 comprising: 1 to 80% (v/w) of the blood product; 1% to 50% (w/w) of the transdermal carrier; and up to 80% (w/w) of the liposomal base.

17. The formulation of claim 16 wherein the blood product is human plasma or plasma lysate, human serum, human PRP (platelet rich plasma), or human autologous conditioned serum; and the transdermal carrier is propylene glycol.

18. A method of treating, preventing or ameliorating a symptom or sign of a skin defect, the method comprising administering to the skin of a subject in need thereof a formulation of claim 1 in an amount sufficient to treat, prevent or ameliorate a symptom or sign of the skin defect.

19. The method of claim 18 wherein the skin defect is selected from the group consisting of poor skin texture, wrinkles, fine lines, UV induced skin damage, skin aging, dry skin, hair follicle deterioration, alopecia, dermatitis, eczema, rash, pruritus, sun burn, burns, stretch marks, acne scars, and surgical scars.

20. The method of claim 19 wherein the skin defect is wrinkles or fine lines and the treatment reduces the number of wrinkles or fine lines by up to 5% compared to the number of wrinkles or fine lines before treatment.

Description

EXAMPLE 1

Plasma Formulation

[0145]

TABLE-US-00001 Exemplary Plasma Formulation Human plasma or plasma lysate: 10 ml Propylene Glycol 10 gm Liposomal base PCCA Lipoderm ® q.s. 80 gm

EXAMPLE 2

Serum Formulation

[0146]

TABLE-US-00002 Exemplary Serum Formulation Human serum 10 ml Propylene Glycol 10 gm Liposomal base PCCA Lipoderm ® q.s. 80 gm

EXAMPLE 3

PRP Formulation

[0147]

TABLE-US-00003 Exemplary Serum Formulation Human PRP (platelet rich plasma) 10 ml Propylene Glycol 10 gm Liposomal base PCCA Lipoderm ® q.s. 80 gm

EXAMPLE 4

ACS Formulation

[0148]

TABLE-US-00004 Exemplary Serum Formulation Human Autologous conditioned serum 10 ml Propylene Glycol 10 gm Liposomal base PCCA Lipoderm ® q.s. 80 gm

EXAMPLE 5

Manufacturing Method

[0149] Each of the formulations is prepared using the following general procedure

[0150] Weigh Lipoderm (gel or cream) in a suitable container.

[0151] Transfer blood product (serum, plasma, PRP, ACS etc) under aseptic conditions to the Lidoderm.

[0152] Add additives such as hyaluronic acid, vitamins, antioxidants, transdermal carriers or enhancers.

[0153] Mix components with gentle agitation.

[0154] Seal the container and allow air to diffuse out of the gel.

[0155] Fill into appropriate tub or airless container. Check pH.

[0156] Typically the formulation will have a pH from 6.0 to 7.0.

EXAMPLE 6

Skin Rejuvenation

[0157] Subjects of good general health and with visible fine or deep wrinkles in the face, were chosen. Subjects with a history of, or active, skin disease were excluded. Subjects were asked to stop their current regime of skin care products. Make-up and sunscreens were permitted.

Treatment Regimen

[0158] The plasma formulation of Example 1 was applied in mornings and evenings to the facial skin for 6 weeks. A treatment group of 5 subjects were asked to document each application of the formulation. A second group was asked to apply a placebo comprising only the lipodermal base (PCCA Lipoderm®) according to the same treatment regimen.

Results

[0159] Subjects were evaluated by a visual assessment of skin quality prior to commencement of the treatment and again after the treatment was complete. Compared to the baseline observations all subjects in the treatment group had significant improvement in texture with the skin feeling firmer and more elastic. There was also a reduction in the number of visible fine lines and wrinkles. In comparison all subjects in the placebo group had no change in skin texture or in the number of visible fine lines and wrinkles compared to baseline observations.

[0160] The number of visible fine lines were reduced by 30% compared to the skin before treatment. Similarly the number of visible wrinkles were reduced by 30% compared to the skin before treatment.

[0161] All subjects liked the way the formulation felt and indicated that they would continue its regular use after the study period.

[0162] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the technology as shown in the specific embodiments without departing from the spirit or scope of technology as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.