Drug – bio-affecting and body treating compositions – Manicure or pedicure compositions
Reexamination Certificate
2000-03-24
2001-10-02
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Manicure or pedicure compositions
C424S405000, C514S772300
Reexamination Certificate
active
06296838
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an anti-fungal herbal formulation for treatment of human nails infected with fungus and a process for preparation of such herbal formulation.
The formulation is also useful for prevention of fungal infections in nails and is useful in ensuring that new growth of nails is free from fungal infections.
BACKGROUND OF THE INVENTION
Wet floors, unclean play grounds, common bath showers unclean bathtubs are breeding ground for dermatophytes, that cause athletes foot and nail infection. Dermatophytes have ability to invade keratinized tissue (skin, hair, nails) but are usually restricted to non living cornified layers of the epidermis because of their inability to penetrate viable tissue of immunocompetent host. The invasion ranges from mild to severe infection. The causative dermatophytes of nail infection are
Trichophyton rubrum
or
Tmenta grophytes
or candida. The nail becomes discoloured and thickens. The thickened nail plate then rises and separates from the nail bed. Fungal infection of the nails besides being a cosmetic problem also has significant psychological, physical and social implications. The incidence of infection of the nail has been on the rise in recent years and is usually treated by topical agents like creams and ointments, which are preferably applied before retiring and are gently massaged into the base of the nail and cuticle.
The management of fungal infection of the nails is carried out by chemical and surgical approach. The formulations available for topical application in form of cream or lotions contain benzoic acid, salicylic acid, imidazole, gresofulvin, zinc undecenoate. Oral supplements such as oral gresofulvin and terbinafine are also recommended.
Topical application based on benzoic acid, salicylic acid and zinc undecenoate has been found to require long term application for four to ten weeks. However, despite this, the recovery is not complete and cases of recurrence have been reported. Moreover, the use of benzoic acid can cause hypersensitivity reactions and is also known to be an irritant to skin, eyes and mucous membrane. Oral grisofulvin and terbinafine hydrochloride supplemented by its topical application has the success rate of 40 to 50 percent but the studies on animal have the evidence that grisofulvin causes toxic effects on liver, thyroid and teratogenicity. Use of terbinafine (5%) both orally and topically, achieves penetration of the keratinizing tissues and success rate is reported to be upto 80 percent. However, common the adverse effects following oral administration are gastrointestinal disturbances, nausea, diarrhoea and headache. Topical reaction causes skin reactions and these adverse effects make the use of this preparation limited.
The present invention improves the drawbacks of the available formulation in the market. The invented formulation is based upon the plant products having synergistic effect hence enhancing the anti-fungal activity with negligible side effects or toxicity. The formulation contains extract from the hulls of
Juglans regia. Juglans regia
(walnut tree) produces nuts (fruits) covered by green hulls. The green hulls separated from mature walnut contain 50 mg percent of Juglone as reported in paper “Some phytochemical characteristic of
Juglans regia,
E. Leinberkovics; E. Hethelyi; E. Hetesi; Acta. Pharm. Hung., 1987, V. 57(3-4), 133-142. Besides juglone, it contains 0.4 to 0.8 percent ascorbic acid. Juglone a simple nethoquinone (5-hydroxy-1,4-nethoquinone) has a moderate antifungal activity as reported in paper “Antimicrobial activity of Juglone. A M Clark; T M Jurgens; C D Hufford. Phytotherpy Research. 1990, 4(1), 11-14.
In the paper “Herbal antifungal cream” M V Devi; A. Suneeta, Journal of Research and Education in Indian Medicine. 1993. 12(1), 1-3 (India), dry extracts of whole nut of
Juglans regia
and
Prunus communis
have been reported to have antifungal activity against Aspergillus species.
OBJECTS OF THE INVENTION
The main object of the present invention is to provide an anti-fungal herbal formulation for treatment of human nails infected with fungus
Another object of the present invention is to provide an anti-fungal herbal formulation for treatment of human nails infected with fungus, which does not cause any sensitizing effect when applied topically on nails.
Another object of the present invention is to provide an anti-fungal herbal formulation useful for protecting the nails against fungal infections, also to keep the new growth of nails free from infections.
Yet another object the present invention is to provide an anti-fungal herbal formulation having a mild keratolytic effect so that it will reach down below the upper bed to lower bed of the nail to prevent infection and the recurrence of the infection.
Another important object of the present invention is to provide a process for the preparation of an anti-fungal herbal formulation useful for treatment of infected human nails, protecting the nails against fungal infections, also to keep the new growth of nails free from infections.
SUMMARY OF THE INVENTION
Accordingly the present invention provides an antifungal composition for the treatment of human nails which comprises from 10-15% extract of walnut hull in acetone or alcohol or butanol wherein Juglone (extract of walnut hull) has been partially fractionated, 20 to 30% of pulverized roots of
Nardostachys jatamansi
or
Vetiveria zizanioides
or
Catharanthus roseus,
5-10% of polyols selected from propylene glycol or polyethylene glycol or ethylene glycol, 5-10% of fixed oil selected from sesame oil, mustard oil, linseed oil 5-10%, 10-15% of non-ionic emulsifiers selected from stearic acid or lanolin or vegetable wax, 15-20% of plasticizer selected from polyvinyl acetate or amyl acetate or food grade gelatin and 20-25% of base selected from nitrocellulose, kaolin or talc.
The present invention also provides a process for the preparation of an antifungal composition for the treatment of human nails which comprises, from 10-15% extract of walnut hull in acetone or alcohol or butanol wherein Juglone has been partially fractionated, 20 to 30% of pulverized roots of
Nardostachys jatamansi
or
Vetiveria zizanioides
or
Catharanthus roseus,
5-10% of polyols selected from propylene glycol or polyethylene glycol or ethylene glycol, 5-10% of fixed oil selected from sesame oil, mustard oil, linseed oil 5-10%, 10-15% of non-ionic emulsifiers selected from stearic acid or lanolin or vegetable wax, 15-20% of plasticizer selected from polyvinyl acetate or amyl acetate or food grade gelatin and 20-25% of base selected from nitrocellulose, kaolin or talc, said process comprising (a) washing the walnut hulls of
Juglan resia
with water, air drying and extracting the said hulls at ambient temperature with acetone, butanol or alcohols, (b) making the extract solvent free by any known method and partially fractionating the said extract by chilling, (c) washing the roots of
Nardostachys jatamansi
or
Vetiveria zizanioides
or
Catharanthus roseus
with water and air drying and powdering the said roots to ≦80 microns to get pulverised material, (d) heating a thickening agent selected from polyvinyl acetate, food grade gelatin and amyl acetate at a temperature of up to 80° C., (e) adding a base selected from nitrocellulose, kaolin or talc for filling by stirring, and (f) adding a fixed oil selected from sesame oil, mustard oil, linseed oil and a polyol selected from propylene glycol or polyethylene glycol or ethylene glycol to the solution from step (e).
The plasticizers are melted at about 80° C. and emulsifier is added followed by the addition of the base selected from kaolin or talc or nitrocellulose and thoroughly stirred. Thereafter, polyol and fixed oils are added. Pulverized root material is added and slowly stirred so that a homogeneous emulsion is formed and extract from walnut hull is added and stirred with a controlled stirring motion at a temperature of 35-40° C.
In an embodiment of the present invention, the walnut hull ex
Bindra Rattan Lal
Kumar Sushil
Shawl Abdul Sami
Singh Anil Kumar
Council of Scientific and Industrial Research
Darby & Darby
Howard S.
Page Thurman K.
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