Title of Invention	A PROCESS FOR THE PREPARATION OF A HERBAL BROAD SPECTRUM ANTIMICROBIAL, DERMATOLOGICAL COMPOSITION
Abstract	(5 ) Abstract: A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition is disclosed. The said composition is prepared by adding mixture A to mixture B under constant stirring and cooling the same to 40C to which finally a preservative solution is added. Mixture A consists of two essential oils in a particular ratio and mixture B containing a base, fixed oil, an antioxidant in a predetermined ratios. However, a homogeneous mixture B is obtained at a temperature around 50oC.

Title of Invention

A PROCESS FOR THE PREPARATION OF A HERBAL BROAD SPECTRUM ANTIMICROBIAL, DERMATOLOGICAL COMPOSITION

Abstract

(5 ) Abstract: A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition is disclosed. The said composition is prepared by adding mixture A to mixture B under constant stirring and cooling the same to 40C to which finally a preservative solution is added. Mixture A consists of two essential oils in a particular ratio and mixture B containing a base, fixed oil, an antioxidant in a predetermined ratios. However, a homogeneous mixture B is obtained at a temperature around 50oC.

Full Text	The present invention relates to a herbal broad spectrum antimicrobial dermatological composition and the process for manufacturing this herbal broad spectrum antimicrobial dermatological composition. Nature has a bounty of plants and natural agents, which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger doses are necessitated, the synthetic agents generally express side effects . More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts, it becomes all the more difficult for the microbes to develop resistance. Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species oiPsuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungal species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases. The present invention serves as a muUipurpose dermatological cream which is effective against a broad range of bacteria and flingi, and also possesses antinflammatory and wound-healing properties. To arrive at this invention, a large number of Indian medicinal plants were screened using 'well-bore' technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novehy of this invention, therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally. Majority of the antimicrobial ointments/creams available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. Moreover, they pose a risk of the microbes developing resistance to them, thus making the formulation ineffective. The present herbal broad spectrum antimicrobial dermatological composition contains natural ingredients having a broad spectrum activity against a range of microbes and are therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these comoounds is neplioihlp ine neroai composition consists of plant derivatives derived from members of Labiatae, Poaceae and the like, Ocimum sanctum is an aromatic herb belonging to the family Labiatae, and is found to occur throughout India. It contains an essential oil which is known to have potent antimicrobial activity and contains a phenyl propanoid compound called eugenol. The chemical structure is given below in figure 1 (enclosed in drawing sheet) Cymbopogon citratus commonly called as Lemon grass is known for its aromatic oil. The oil contains a substance called Citral which is responsible for its characteristic. Cymbopogon citratus is a grass belonging to the family Poaceae. The chemical structure is given below in figure 2 (enclosed in drawing sheet) According to the present invention, a process for the preparation of a herbal board spectrum anti microbial, dermatological composition comprising, (a) the mixutre - A (consisting of two essential oils)taken in the range of 1 - 5% w/w, which are mixed and stirred, (b) the base material (consisting of a plurality of wares) taken in the range of 12-16% by w/w, and melting the said base materials over moist heat to obtain a soft paste, (c) adding a fixed oil to the above said soft paste in the range of 8 -12% w/w, and stirring the said mixture of base and oil continuously, (d) adding an anti-oxidant in the range of 0.20 - 0.07 w/w to the above said mixture (obtained in step c), (e) adding solubuliser in the range of 3 - 5% w/w to the said mixure, (f) heating the said mixture (which is obtained in step-e) to the temperature of 50 - 70°C under a moist temperature to obtain a homogenous Mixture - B, (g) adding the said Mixture - A to the Mixture - B under stirring and cooling the said mixture to 40 - 45°C, (h) adding the preservative solution under stirring in the range of 0.5 to 2% w/w, and finally adding the water under stirring at 40 - 45°C temperature to make the composition 100% w/w, cooling the said composition to room temperature to obtain homogenous cream. The essential oils to obtain the mixture A are minimum two, preferably Cymbopogon citratus and Ocimum sanctum, mixed in the ratio of 1:2. The base material consists of plurality of waxes such as: 1. Cetyl alcohol 2 to 5% w/w. 2. Stearic acid 3.5 to 5.5% w/w. 3. Glyceryl monostearate 2 to 5% w/w. 4. Ethylene glycol monostearate 0.1 to 2.5% w/w. Example -1 A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprising, a) the mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 2.5% w/w, b) the base (prepared by melting Cetyl alcohol - 2%, Stearic acid - 5.5%, Glyceryl monostearate -2% , Ethylene glycol monostearate- 2.5%) is taken in the percentage of 12% w/w, c) adding the fixed oil in the percentage of 12% w/w to the above said soft paste obtained in step- b under stirring, I d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.07% w/w along with solubliser in the percentage of 3% w/w, e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B", f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C and finally adding a preservative solution at a strength of 2% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w. The above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprising, a) the mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 3% w/w, b) the base (prepared by melting Cetyl alcohol - 3.5%, Stearic acid - 4.25%, Glyceryl monostearate - 4.25%, Ethylene glycol monostearate - 2%) is taken in the percentage of 14% w/w, c) adding the fixed oil in the percentage of 14% w/w to the above said soft paste obtained in step-fa under stirring, d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.05% w/w along with solubliser in the percentage of 4% w/w, e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B", f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C, and finally adding a preservative solution at a strength of 1.5% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w. The above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream. A PROCESS FOR THE PREPARATION OF A HERBAL BROAD SPECTRUM ANTIMICROBIAL, DERMATOLOGICAL COMPOSITION. Nature has a bountry of plants and natural agents which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger does are necessitated, the synthetic agents generally express side effects. More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts, it becomes ail the more difficult for the microbes to develop resistance. Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species of Psuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungi species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases. The present invention serves as a multipurpose dermatological cream which is effective against a broad range of bacteria and fungi, and also possesses antiinflammatory and wound-healing properties. To arrive at this novel invention, a large number of Indian medicinal plants were screened using 'well-bore' technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novelty of this invention therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally. We claim:- 1. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprises, a) the Mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 1 - 5% w/w, b) the base (prepared by melting Cetyl alcohol - 2 - 5 %, Stearic acid - 3.5 - 5.5%, Glyceryl monostearate - 2 - 5% , Ethylene glycol monostearate - 0.1 - 2.5%) is taken in the percentage of 12% - 16% w/w, c) adding the fixed oil in the percentage of 8 - 12% w/w to the above said soft paste obtained in step- b under stirring, d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.02 - 0.07% w/w along with solubliser in the percentage of 3% - 5% w/w, e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B", f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C and finally adding a preservative solution at a strength of 0.5 - 2% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w, finally above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream. 1. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 2 where in the percentage of Cymbopogon citratus is 20 to 45% by weight of a mixture, and the percentage of Ocimum sanctum is 40 to 80% by weight of mixture A. 2. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 1, wherein the Glyceryl monostearate (self emulsifying grade) is 2 to 5% by weight of the composition. 3. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 1, where in the Ethylene glycol monostearate is 0.1-2.5% by weight of the composition. 4. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 1, where in the Butylated hydroxy toluene -0.05-0.25% by weight of the composition. 5. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 1, where in the Propylene glycol is 2.5% by weight of the composition. 6. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 1, where in the Phenoxy ethanol is-0.01-2.0% and Bronopol (2 brono-2-nitro propane-1-3-diol) is-0.01-0.2 % by weight of the composition. 7. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition herein described with references to the accompanying examples.

Full Text

The present invention relates to a herbal broad spectrum antimicrobial dermatological composition and the process for manufacturing this herbal broad spectrum antimicrobial dermatological composition.
Nature has a bounty of plants and natural agents, which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger doses are necessitated, the synthetic agents generally express side effects . More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts, it becomes all the more difficult for the microbes to develop resistance.
Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species oiPsuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungal species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases.
The present invention serves as a muUipurpose dermatological cream which is effective against a broad range of bacteria and flingi, and also possesses antinflammatory and wound-healing properties. To arrive at this invention, a large number of Indian medicinal plants were screened using 'well-bore' technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novehy of this invention, therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally.
Majority of the antimicrobial ointments/creams available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. Moreover, they pose a risk of the microbes developing resistance to them, thus making the formulation ineffective. The present herbal broad spectrum antimicrobial dermatological composition contains natural ingredients having a broad spectrum activity against a range of microbes and are therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these comoounds is neplioihlp

ine neroai composition consists of plant derivatives derived from members of Labiatae, Poaceae and the like,
Ocimum sanctum is an aromatic herb belonging to the family Labiatae, and is found to occur throughout India. It contains an essential oil which is known to have potent antimicrobial activity and contains a phenyl propanoid compound called eugenol. The chemical structure is given below in figure 1 (enclosed in drawing sheet)
Cymbopogon citratus commonly called as Lemon grass is known for its aromatic oil. The oil contains a substance called Citral which is responsible for its characteristic. Cymbopogon citratus is a grass belonging to the family Poaceae. The chemical structure is given below in figure 2 (enclosed in drawing sheet)
According to the present invention, a process for the preparation of a herbal board spectrum anti microbial, dermatological composition comprising,
(a) the mixutre - A (consisting of two essential oils)taken in the range of 1 - 5% w/w, which are mixed and stirred,
(b) the base material (consisting of a plurality of wares) taken in the range of 12-16% by w/w, and melting the said base materials over moist heat to obtain a soft paste,
(c) adding a fixed oil to the above said soft paste in the range of 8 -12% w/w, and stirring the said mixture of base and oil continuously,
(d) adding an anti-oxidant in the range of 0.20 - 0.07 w/w to the above said mixture (obtained in
step c),
(e) adding solubuliser in the range of 3 - 5% w/w to the said mixure,
(f) heating the said mixture (which is obtained in step-e) to the temperature of 50 - 70°C under a moist temperature to obtain a homogenous Mixture - B,
(g) adding the said Mixture - A to the Mixture - B under stirring and cooling the said mixture to 40 - 45°C,
(h) adding the preservative solution under stirring in the range of 0.5 to 2% w/w, and finally adding the water under stirring at 40 - 45°C temperature to make the composition 100% w/w, cooling the said composition to room temperature to obtain homogenous cream.

The essential oils to obtain the mixture A are minimum two, preferably Cymbopogon citratus and Ocimum sanctum, mixed in the ratio of 1:2.
The base material consists of plurality of waxes such as:
1. Cetyl alcohol 2 to 5% w/w.
2. Stearic acid 3.5 to 5.5% w/w.
3. Glyceryl monostearate 2 to 5% w/w.
4. Ethylene glycol monostearate 0.1 to 2.5% w/w.
Example -1
A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprising,
a) the mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 2.5% w/w,
b) the base (prepared by melting Cetyl alcohol - 2%, Stearic acid - 5.5%, Glyceryl monostearate -2% , Ethylene glycol monostearate- 2.5%) is taken in the percentage of 12% w/w,
c) adding the fixed oil in the percentage of 12% w/w to the above said soft paste obtained in step-
b under stirring,
I
d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.07% w/w along with solubliser in the percentage of 3% w/w,
e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B",
f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C and finally adding a preservative solution at a strength of 2% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w.
The above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream.

A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprising,
a) the mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 3% w/w,
b) the base (prepared by melting Cetyl alcohol - 3.5%, Stearic acid - 4.25%, Glyceryl monostearate - 4.25%, Ethylene glycol monostearate - 2%) is taken in the percentage of 14% w/w,
c) adding the fixed oil in the percentage of 14% w/w to the above said soft paste obtained in step-fa under stirring,
d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.05% w/w along with solubliser in the percentage of 4% w/w,
e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B",
f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C, and finally adding a preservative solution at a strength of 1.5% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w.
The above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream.

A PROCESS FOR THE PREPARATION OF A HERBAL BROAD SPECTRUM ANTIMICROBIAL, DERMATOLOGICAL COMPOSITION.
Nature has a bountry of plants and natural agents which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger does are necessitated, the synthetic agents generally express side effects. More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts, it becomes ail the more difficult for the microbes to develop resistance.
Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species of Psuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungi species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases.
The present invention serves as a multipurpose dermatological cream which is effective against a broad range of bacteria and fungi, and also possesses antiinflammatory and wound-healing properties. To arrive at this novel invention, a large number of Indian medicinal plants were screened using 'well-bore' technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novelty of this invention therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally.

We claim:-
1. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition comprises,
a) the Mixture-A (consisting of two essential oils ie., Ocimum sanctum and Cymbopogon citratus which are taken 1 and 2 parts respectively) is taken in the percentage of 1 - 5% w/w,
b) the base (prepared by melting Cetyl alcohol - 2 - 5 %, Stearic acid - 3.5 - 5.5%, Glyceryl monostearate - 2 - 5% , Ethylene glycol monostearate - 0.1 - 2.5%) is taken in the percentage of 12% - 16% w/w,
c) adding the fixed oil in the percentage of 8 - 12% w/w to the above said soft paste obtained in step- b under stirring,
d) adding an anti oxidant ( Butylated hydroxy toulele ) to the mixture obtained in step -c in the percentage of 0.02 - 0.07% w/w along with solubliser in the percentage of 3% - 5% w/w,
e) heating the above said mixture ( which is obtained in step 'd') upto 50°C under a moist temperature to obtain a homogenous mixture "B",
f) adding mixture A to mixture B under constant stirring and cooling the same to 40°C and finally adding a preservative solution at a strength of 0.5 - 2% w/w along with water under constant stirring at 40 - 45°C to make the composition 100% w/w,
finally above said composition is cooled to room temperature with continuous stirring to obtain homogenous cream.
1. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological composition as claimed in claim 2 where in the percentage of Cymbopogon citratus is 20 to 45% by weight of a mixture, and the percentage of Ocimum sanctum is 40 to 80% by weight of mixture A.

2. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition as claimed in claim 1, wherein the Glyceryl monostearate (self emulsifying grade)
is 2 to 5% by weight of the composition.
3. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition as claimed in claim 1, where in the Ethylene glycol monostearate is 0.1-2.5% by
weight of the composition.
4. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition as claimed in claim 1, where in the Butylated hydroxy toluene -0.05-0.25% by
weight of the composition.
5. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition as claimed in claim 1, where in the Propylene glycol is 2.5% by weight of the
composition.
6. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition as claimed in claim 1, where in the Phenoxy ethanol is-0.01-2.0% and Bronopol (2
brono-2-nitro propane-1-3-diol) is-0.01-0.2 % by weight of the composition.
7. A process for the preparation of a herbal broad spectrum antimicrobial, dermatological
composition herein described with references to the accompanying examples.

Documents:

78-mas-1998 abstract.pdf

78-mas-1998 claims.pdf

78-mas-1998 correspondence others.pdf

78-mas-1998 correspondence po.pdf

78-mas-1998 description (complete).pdf

78-mas-1998 form-1.pdf

78-mas-1998 form-13.pdf

78-mas-1998 form-26.pdf

78-mas-1998 form-4.pdf

78-mas-1998 form-5.pdf

78-mas-1998 form-6.pdf

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Patent Number

186856

Indian Patent Application Number

78/MAS/1998

PG Journal Number

30/2009

Publication Date

24-Jul-2009

Grant Date

Date of Filing

20-Apr-1998

Name of Patentee

M/S. NATURAL REMEDIES PVT.LTD

Applicant Address

PLOT NO.5B, 19TH K.M.STONE, VEERASANDRA INDL.AREA, HOSUR ROAD, BANGALORE 561 229

Inventors:

#	Inventor's Name	Inventor's Address
1	AMIT AGARWAL	M/S NATURAL REMEDIES PVT, LTD., PLOT 5B, VEERASANDRA INDL, AREA, 19TH K.M.STONE, HOSUR ROAD,

PCT International Classification Number

A61K 35/78

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA