Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2001-08-06
2003-02-18
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from zingiberaceae
C424S059000, C424S060000, C424S062000, C514S165000, C514S557000, C514S729000, C514S730000, C514S731000, C514S732000
Reexamination Certificate
active
06521271
ABSTRACT:
FIELD OF TEE INVENTION
The present invention is directed to compositions comprising at least one component of turmeric (including, without limitation curcumin and turmerin) and one or more hydroxy acids, and methods of using these compositions to promote improvement of skin condition.
BACKGROUND OF THE INVENTION
Curcuma longa
(Fam. Zingiberaccae) or Turmeric is one of the oldest herbs in Ayurveda materia medica, and has been used in Ayurveda medicine internally as a stomach, tonic and blood purifier, and topically in the prevention and treatment of skin diseases. Turmeric is a spicy plant that is a common ingredient in curry powder, usually in combination with other herbs such as cayenne, garlic, cumin and onion. Turmeric is also used as an additive in prepared mustard.
The significance of turmeric in medicine has changed considerably since the very recent discovery of the anti-oxidant properties of naturally occurring phenolic compounds. The same ground dried rhizome of
Curcuma longa,
which has been used for centuries as a spice, food preservative and a coloring agent, has been found to be a rich source of phenolic compounds or curcuminoids. There are three main curcuminoids recognized, i.e., curcumin (diferuloylmethane), demethoxy curcumin(p-hydroxycinnamoyl-feruloylmethane) and bis demethoxycurcumin (p,p-dihydroxydicinnamoylmethane).
Curcuminoids have scientifically documented anti-oxidant, anti-inflammatory, anti-bacterial, anti-fungal, antiparasitic, anti-mutagen, anti-cancer and detoxification properties. Their potential use in the prevention of cancer and in the treatment of infection with human immunodeficiency virus (HIV) are the subject of intensive laboratory and clinical research. Curcuminoids are recognized for their broad biological activity and safety of use.
The pharmacokinetics involving the safety, toxicity, dose range, and biological properties of turmeric and its components, including curcumin and turmerin, are known, and the turmeric is readily available in various food stores.
Extensive in vitro and in vivo testing has shown that turmeric inhibits chemically-induced epidermal ornithine decarboxylase activity, epidermal DNA synthesis, and the promotion of skin tumors in mice (Conney A H et al., Adv. Enzyme Regul., 31:385-396, 1991; Huang M T et al., Cancer Res., 48:5941-5945, 1988; Lu Y P et al., Carcinogenesis, 14:293-297, 1993; Azuine M A, Bhide S V, Nutr Cancer, 17:77-83, 1992). Further studies suggest that turmeric also reduces arachidonic acid-induced rat paw and mouse skin edema and markedly inhibits epidermal lipoxygenase and cyclooxygenase activity in vitro (Rao T S et al., Indian J. Med. Res., 75:574-578, 1982; Conney A H et al., Adv. Enzyme Regul., 31:385-396, 1991; Huang M T et al., Cancer Res., 48:5941-5945, 1988). In humans, ingestion of turmeric has demonstrated a bacteriostatic or bacteriocidal effect against organisms involved in cholecystitis and has been used to treat biliary infections (Ramprasad C et al., Ind. J. Phys. and Pharm., 1:136-143, 1957; Lutumski J et al., Planta Med., 26:9-19, 1974). Topical application of a turmeric paste for the treatment of scabies has also shown good results (Charles V, Charles S X., Trop. Geogr. Med., 44:178-181, 1992).
It has been recently shown that curcumin decreased p24 antigen production in acutely or chronically infected cells with HIV-1, a paradigm of anti-viral activity (Li C J et al., Proc. Natl. Acad. Sci. USA, 90:1839-1842, 1993). Administration of curcumin in mice significantly reduced the scavenging of peroxides and other activated oxygen species, exhibiting its antioxidant property (Soudamini K K et al., Indian J. Phys. Pharmacol. 36:239-243, 1992). Oral administration of curcumin in human volunteers has been shown to significantly decrease the level of serum lipid peroxides (33%), increase HDL cholesterol (29%), and decrease total serum cholesterol (11.63%) (Soni K B, Kuttan R., Indian J. Phys. Pharmacol., 36:273-275, 1992).
The addition of turmeric to diet has been shown to inhibit azoxymethanol-induced colonic epithelial cell proliferation and focal areas of dysplasia (Huang M T et al., Cancer Letters, 64:117-121, 1992). It has also been shown to interfere with the formation of covalent carcinogen-DNA adducts (Mukudan M A et al., Cardnogenesis, 14:493-496, 1993).
Fat metabolism is likewise influenced by curcumin. It can render bile non-lithogenic in mice (Hussain M S et al., Indian J. Med. Rcs., 96:288-291, 1992). Curcumin can reduce the production of PMA-induced lipid peroxidation and 8-OH-deoxyguanosine formation in mouse fibroblast cells (Shih C-A, and Lin J-K, Carcinogenesis, 14:709-712, 1993).
Phosphorylation events can also be influenced by curcumin, as it has been reported that curcumin inhibits protein kinase C activity induced by 12-O-tetradecanoyl-phorbol-13-acetate in NIH 3T3 cells (Liu, J-Y, Lin, S-J, and Lin, J-K., Carcinogenesis, 14:857-861).
Curcumin inhibits the immune as well as the smooth muscle cell proliferation. Human peripheral blood mononuclear cells were inhibited in response to phytohemagglutinin and mixed lymphocyte reaction. Furthermore, curcumin inhibited the proliferation of rabbit vascular smooth muscle cells stimulated by fetal calf serum. Curcumin had a greater inhibitory effect on platelet derived growth factor-stimulated proliferation than on serum-stimulated proliferation (Huang H-C et al., Eur. J. Pharmacol., 221:381-384, 1992).
The anti-inflammatory properties of curcumin were shown to inhibit the 5-lipoxygenase activity in rat peritoneal neutrophils as well as the 12-lipoxygenase and the cyclooxygenase activities in human platelets (Ammon H P T et al, J. Ethopharmacol., 38:113-119, 1993). Curcumin had no significant effect on quercetin-induced nuclear DNA damage, lipid peroxidation and protein degradation and thus has the unique potential of acting as both pro- and antioxidants, depending on the redox state of their biological environment (Saura C et al., Cancer Letters, 63:237-241, 1992).
Alpha hydroxy acids, and more recently beta hydroxy acids, are commonly used as cosmetics to reduce wrinkles, spots and other signs of aging. Unfortunately, higher doses can cause undesirable side effects, including severe redness, swelling, burning, blistering, bleeding, rash, itching and skin discoloration. Alpha Hydroxy Acids for Skin Care, U.S. food and Drug Administration, FDA Consumer, March-April, 1998.
Most often used of the alpha hydroxy acids are glycolic acid and lactic acid, although several are useful alone or in combination with other alpha hydroxy acids.
What is needed is a composition and method of topically delivering alpha hydroxy acids and curcumin to the skin in doses that are highly effective without causing significant skin irritation.
SUMMARY OF THE INVENTION
The present invention is directed to compositions comprising at least one of the components of turmeric (such as curcumin or turmerin) and alpha hydroxy acid, and methods of using these compositions to promote improvement of skin condition. Various skin conditions can be treated in accordance with the present invention, including, but not limited to, conditions associated with scarring, unwanted pigmentation and aging of the skin. The present invention exhibits improved activity over the use of turmeric, curcumin or turmerin alone. Without limiting the scope of the invention, it is believed that the glycolic acid acts to enable the penetration.
After the administration of the combination of curcumin or turmerin and an alpha hydroxy acid, the skin is restored to a healthier and smoother appearance having improved texture and resilience. In accordance with the present invention, the skin disorders are preferably treated by administering the compositions of the present invention topically.
The present invention encompasses compositions comprising curcumin (and/or turmerin) and glycolic acid. In one embodiment, the amount of curcumin present is between approximately 0.1 and 20 &mgr;g/ml, preferably between approximately 1 and 5 &mgr;g/ml, more preferably between approximately 2 and 3 &mg
Baker Gary
Phan Dung
Quine Intellectual Property Law Group P.C.
Tate Christopher R.
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