Honey preparations

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice

Reexamination Certificate

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Details

C424S070100, C424S074000, C514S023000

Reexamination Certificate

active

06171604

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to methods and products for treating wounds and skin conditions and for stimulating hair growth.
Honey has been shown to have considerable wound and ulcer healing capacity and strong antimicrobial activity. Recognizing those utilities, members of the medical profession have engaged in treatment protocols involving the local application of honey. Wounds and ulcers which were unresponsive to conventional treatments have, when treated with honey, become sterile within one week. In 1980 it was reported that necrotic malignant breast ulcers were effectively treated with honey. Wounds disrupted after caesarean sections have been shown to heal after application of a thin layer of honey without the need for resuturing. Open wounds, infected wounds, e.g., vulvectomy, infected perineum and infected abdominal wall wounds healed faster when treated with honey than when treated conventionally. Healing processes are generally not hindered by the presence of microorganisms in the honey or in the infected wounds or ulcers. Even when wounds are challenged with high inocula of infectious bacteria, honey remains superior to conventional wound healing medications, with the honey-treated wounds exhibiting less neutrophil infiltration and marked proliferation of angioblasts and fibroblasts. Honey dressings have also proven superior in the treatment of superficial wounds and burns, with patients experiencing increased wound sterilization, earlier healing, more pain relief and less irritation without allergies and other side effects often experienced during conventional healing processes. Honey also appears to promote rapid wound debridement, replacement of sloughs with granulation tissue and rapid epithelialization and absorption of oedema from around the margins.
Honey has great potential for use as a medicinal antimicrobial. That potential has been demonstrated by the tremendous amount of research in that area. Honey exhibits pronounced microbial activity against most pathogenic bacteria and fungi regardless of their susceptibility or resistance to different antibiotics. The antimicrobial activity of honey was attributed to its high sugar osmolarity and low acidity, but honey has been shown to have stronger antimicrobial activity than corresponding sugar concentrations with similar pHs. The antimicrobial activity has also been attributed to the enzymatically liberated hydrogen peroxide activity known as inhibine. It should be noted, however, that some types of honey, such as manuka honey, exhibit marked antibacterial activity in the absence of peroxide activity. Manuka honey is currently being marketed in New Zealand as an antibacterial product.
Honey has revealed moderate antitumor and pronounced metastatic effects when tested in rats; the antitumor activity of 5-fluorouracil and cyclophosphamide is potentiated by honey. Scientific literature has also suggested honey applications for treating cardiovascular diseases, cataracts and bronchial asthma and for preserving graft tissues. Further, honey has proven effective in treating cold sores and herpes simplex on the lips, skin allergies and insect bites.
While honey has proven effective as a treatment, topical application of honey is inconvenient. The stickiness, thinning and liquefaction accompanying existing honey applications are major restrictions to their topical application. Thinning and liquefaction of existing preparations increases honey mobility, resulting in poor dosing. That mobility exacerbates the stickiness problem, as the treatment inevitably drips and spreads to other areas, including clothes. When existing honey applications are applied to exposed tissues such as open wounds or eyes, intense irritation results from the high osmolarity of honey. Needs exist for honey-based treatments having physical characteristics conducive to topical application.
SUMMARY OF THE INVENTION
The present invention includes a honey formulation for topical application. The formulation includes the active ingredients of honey and related products and may take the form of a cream, gel, ointment, paste, lotion or the like. Unlike existing preparations, the present formulation has reduced stickiness and irritability and a controlled consistency. Those characteristics allow the present preparation to be conveniently applied topically at desired doses for therapeutic, cosmetic and nutritional purposes.
The present preparation includes the unaltered, active constituents of honey, including sugars, proteins, vitamins, enzymes, hormones, minerals and other substances. It is those active constituents that provide the preparation with its therapeutic, cosmetic and nutritional benefits. The physical characteristics of honey are modified, while keeping the active ingredients intact, to suit various applications.
The present preparation has reduced stickiness and a consistency that allows small and large doses to be applied topically without liquefaction. When applied to open wounds and sensitive tissues, irritant sensations are not experienced.
Preparations made in accordance with the present invention are based at least in part on the tissue healing capacity and the antimicrobial activity of honey. The present honey preparations are particularly effective in tissue regeneration and healing due to the presence of unaltered active constituents which are present in honey. It is those constituents that make honey effective therapeutic, cosmetic and nutritional treatments. The prominent antimicrobial activity of honey against microorganisms is due in part to the inhibine activities and related mechanisms present in honey. Due to those healing mechanisms and antimicrobial activities, the present honey preparations are superior in treatment of wounds, burns, ulcers, infections, skin, scalp and hair disorders, and other tissue conditions, including those of the eye, nose, ear and mouth.
The composition of honey is unique, as it encompasses a large profile of nutrients including sugars, amino acids, vitamins such as biotin, nicotinic acid, floic acid, pantothenic acid, pyridoxine and thiamine, enzymes such as diastase invertase, glucose oxidase and catalase, and minerals such as potassium, iron, magnesium, phosphorous, copper and calcium. Several of those components have been used individually or in combination in cosmetic or therapeutic scalp and hair preparations. In the present preparation, the complete composition of honey remains intact. When topically applied, the present preparation promotes hair growth, thickens thinning hair, prevents and reduces hair loss, treats dandruff and other scalp disorders, and softens skin. The unique honey composition provides essential nutrients to activate and regenerate hair follicles, to support strong hair growth, and to restore hair color prior to graying.
The present invention provides methods and preparations for treating skin, scalp and hair conditions using the active ingredients of honey. While it is preferred to use honey as a whole, the active ingredients may be extracted or artificially synthesized and used individually or in combinations. The present preparations are effective in treating a wide range of conditions including, but not limited to, burns, wounds, cold sores, viral infections, bacterial infections, fungal infections, acne, psoriasis, allergies, rashes, skin dryness dermatitis, poison ivy, insect bites, and similar skin conditions.
The present invention contemplates a base for other medicaments and/or cosmetic ingredients that have value to treat particular conditions.
It is a further object of the present invention to provide methods and preparations for treating skin, scalp and hair conditions wherein the treatment composition is topically applied to the skin and/or hair and hair follicles. The treatment agent includes sugar components, vitamins, minerals, proteins, enzymes and hormones existing in honey as is, extracted from bee honey, or synthesized and used individually or in mixtures.
Without the present invention, the application of honey by itse

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