Herbal formulation useful as a therapeutic and cosmetic...

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex

Reexamination Certificate

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C424S401000, C514S858000, C514S860000, C514S861000, C514S886000, C514S969000

Reexamination Certificate

active

06200570

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a herbal cream formulation useful for therapeutic and cosmetic applications: cracked heels, dry skin disorder, skin allergies, depigmentation and anti fungal activity. In the formulation of the present invention, the herbs that are used are known to possess anti-inflammatory, antiallergic and wound healing properties. The formulation may also be useful in treating chopped hands, hyperkeratosis and minor cuts and burn wounds.
BACKGROUND OF THE INVENTION
Skin acts as a barrier between body and its environment maintaining a controlled dynamic equilibrium. Stresses imposed by environment can cause changes in skin and major purpose of creams under consideration is to help reverse these changes and maintain a normal healthy skin. Cracking of heels is a common problem, which is observed in almost all individuals in extreme winter and summer seasons in tropical climates. Skin is a protein gel hydrated in its inner most layers and largely dehydrated in its surface layer. The purpose of water in the outer corneous layer of skin is of great physiological importance in that (1) certain amount of desiccation from skin surface minimises bacterial multiplication and assists in maintaining integrity. (2) The continual desquamation of skin is nature's method of removing debris and foreign matter, which are generally embedded in skin apertures.
It is not desirable that drying of skin layer should proceed to such an extent that corneous layer prematurely flakes away and cracks develop on the skin surface.
Cracks on the heels, in extreme winter season, develop because of the closure of the pores in the outermost layers. This problem worsens if the atmosphere has low humidity. Cracks on heels are also developed in extreme summer seasons because of migration of water from innermost layers and subsequent evaporation from outer skin surface in low humid environment. In both cases, it is necessary to maintain the integrity of the skin by balancing water content in skin layers and to promote healing of fissures that develop upon prolonged exposure.
PRIOR ART DISCUSSION
In the market, at present, a number of formulations are available for cracked heels. The composition in all the preparations are different and some of them contain synthetic drugs like Salicylic acid as one of the ingredients. All the preparations are required to be used continuously for better performance of healing of the cracks developed on heels. There are some preparations, which are used for skin rashes and fungal infections between fingers and toes. Following are the preparations available with their ingredients. “Vaseline Heal Guard” of Ponds India ltd. contains the active ingredients: Salicylic Acid IP—1.5 w/w, Lactic Acid—8.0 w/w, Triclosan—0.1 w/w and Cream base-QS. “Krack” of Paras Pharmaceuticals, Kalol contains: Dodishak and Sarjaras-ab35.4%, Raktapuraka-ab3.6%, Base to make 100%. “Lichensa” by Dollar Co.P. Ltd. Chennai, contains: Clotrimazole—0.50% w/w, Menthol—1.0% w/w, Ichthammol IP66—0.20% w/w, Boric acid—1.0% w/w, Zinc oxide—5.0% w/w and Lanolin base to −100% w/w., which is also claimed as stainfree. “Link ointment” by Link, Hyderabad contains: Madhuchist—19.5%, Erandi Thail—58.5%, Karpoor—2.5% and Base—19.5%.
SUMMARY OF THE INVENTION
Accordingly, studies were undertaken to develop cream formulations containing herbal drugs and synthetic ingredients for topical application over the affected areas which will help healing of cracks on heels and also minor burn wounds and cuts on the skin. These formulations have proven usefulness in removal of pigmentation on surface of the skin and reducing the allergic reactions and can also be used in cosmetic therapy.
OBJECTS OF THE INVENTION
The objective of the present invention is to provide a herbal formulation useful for therapeutic and cosmetic applications such as cracked heels, dry skin disorder, skin allergies, depigmentation and anti fungal activity, which obviates the drawbacks of the present formulations available in the market.
Another object of the present invention is to prepare a herbal cream using the formulations of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Accordingly, the present invention provides a herbal cream formulation useful for therapeutic and cosmetic applications such as cracked heels, dry skin disorder, skin allergies, depigmentation and anti fungal activity. Which comprises plant parts or oils from medicinal plants or any drug or their mixture thereof having anti-inflammatory and would healing property like
Gymnena sylvestrae
water extract 3 to 6%,
Tridax procumbens
water extract 3 to 6% or methanolic extract 4 to 6%,
Allium sativum
(garlic) oil (Hexane extract) 1 to 3%,
Aloe vera
(dried juice) 2 to 6%,
Gum olibanum
powder in the natural state 4 to 7%,
Gum olibanum
resinoid hexane extract 4 to 6% or ethanol extract 4 to 6% or methanol extract 3 to 8% and
Gum olibanum
meal, resinoid free, (Resin extracted with methanol or ethanol or n-hexane) 5 to 10%, cream or gel bases containing carbopol-934 1 to 4% , emulsifying ointment 20 to 40%, preservatives such as methyl and propyl parabens 0.1 to 0.3% and p-chloro cresol 0.05 to 0.2%, humectants such as propylene glycol 1 to 3%, and Glycerine 1 to 4%, Diclofenac sodium 1-3%, Salicylic Acid 1 to 4%, Piroxicam 1 to 2%, Turmeric powder 0.1 to 1%.
In the embodiment of the present invention, plant extracts used may be
Gymnema sylvestrae, Ocimium sanctum, Gum olibanum, Tridax procumbens, Allium sativum, Aloe vera,
Turmeric, from any part of the plant such as leaf, root, bark, natural exudation of the bark, flower, fruit, stem or branch.
In another embodiment of the present invention the known drugs having anti-inflammatory and wound healing property used may be such as Salicylic acid, Piroxicam, Diclofenac sodium.
In still another embodiment of the present invention the base used may be such as aqueous cream base (containing emulsifying ointment BP 1993, preservative and water) or gel base (containing propylene glycol, carbopol 934 and monoethanol amine).
In yet another embodiment of the present invention the preservatives used may be such as Methyl paraben, Propyl paraben, p-Chlorocresol.
In still another embodiment of the present invention the humectants used may be as Glycerine and Propylene glycol.
As a result of intensive study conducted by the inventors with the aim of achieving afore mentioned objectives, new processes for the preparation of cream formulations for topical use were developed employing herbal drugs which are from natural origin, incorporating them into cream bases along with synthetic materials which are known to possess water retaining properties.
Accordingly, the present investigation deals with cream and gel based topical formulations. Each formulation has been described in detail giving the formula of the ingredients along with method of preparation.
The first step in the preparation of these formulations involves a process for making the plant material suitable for incorporating into cream/gel bases. The specified portion of the plant is collected and dried under shade at room temperature in an enclosed room for 72 hrs or more until the material gets dried. A specified amount of material is then extracted with solvents like n-hexane, chloroform, ethanol, methanol and water, in cold/hot condition. The choice of the solvent depends upon the type of material expected at the end of extraction process. Extraction process was carried out in a closed container immersing specified amount of the plant material in respective solvents for 72 hrs. At the end of this stage, solvent is decanted and filtered if necessary to make it free from the plant debris. The solvent is then concentrated by evaporating under vacuum at room temperature. If the solvent used is water, then concentrated solution is freeze dried to obtain the final product in powder form. If the solvent used is a non-polar solvent then final product would be an oily and viscous substance with specific physico-chemical properties. This f

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