METHOD OF PREPARING GARLIC OINTMENT AND GARLIC OINTMENT COMPOSITION FOR TOPICAL USE IN SKIN INFECTIONS

Title:

METHOD OF PREPARING GARLIC OINTMENT AND GARLIC OINTMENT COMPOSITION FOR TOPICAL USE IN SKIN INFECTIONS

Document Type and Number:

WIPO Patent Application WO/2002/089826

Kind Code:

A1

Abstract:

Garlic Ointment of the present invention is an effective antibacterial and antifungal ointment for tropical use in skin infections. The object of this ointment is to utilize all constituents of garlic to achieve maximum benefit. Allin and Allicin are stablized in the ointment. The preparation comprises of freeze dried garlic powder together with a pharmaceutically acceptable carrier therefore. The composition may be applied topically in treatment of general skin infections.

Inventors:

SURI SANJAY (IN)
SINGH J (IN)
DHUPPAD ULHAS (IN)
BHATHAM A K (IN)

Application Number:

PCT/IN2001/000098

Publication Date:

November 14, 2002

Filing Date:

May 04, 2001

Export Citation:

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Assignee:

MOREPEN LAB LTD (IN)
SURI SANJAY (IN)
SINGH J (IN)
DHUPPAD ULHAS (IN)
BHATHAM A K (IN)

International Classes:

A61K36/00; A61K36/8962; (IPC1-7): A61K35/78

Foreign References:

US4569839A

1986-02-11

Other References:

DATABASE WPI [online] JEMUKO K.K.: "Agent for body ringe - contains anti-pruritic agent, partic garlic extract", XP002906155, accession no. WEST Database accession no. 1996-350145

Attorney, Agent or Firm:

Goel A. K. (Ashoka Trade Marks Co. Bengali Market 4 Central Lane New Delhi 1 Maharashtra, IN)

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Claims:

ME CLAIM:

1.

A method of preparing ointment for topical use comprising the steps of (i) dispersing the freezed dried garlic powder in the light liquid paraffin with mechanical stirer to get homogenous mixture of garlic powder and light liquid paraffin in the ratio of 1:5 to 7:10 (w/w %). Preferred ratio is 1.5:10. (ii) mix microcrystalline wax in white soft paraffin in the ratio of 2:70 to 10:90 (w/w %). By heating the mixture in hot water b. : th and continously stirring to get a homogenous mixture of microcrystalline wax and white soft paraffin at temperature ranges of 6065°C, preferred ratio is 5:83.4 (w/w %). (iii) cooling the mixture prepared in step (ii) to ca 40 C and adding the mixture of garlic powder and liquid paraffin prepared under step (i) above and stirring continuously to get homogenous mixture, at a temperature o of 4045 C. (iv) cooling down the preparation of step (iii) to 30°C and adding suitable prefume to give pleasant smell using a mechanical stirrer.

2.

method of preparing an ointement as claimed in claim 1 wherein the ratio (w/w X) of dried garlic powder to light liquid paraffin is 1:5 to 7:10 preferrably 1.5:10. 3. A method of preparing an ointment as claimed in claim 1 wherein the ratio (w/w %) of microcrystalline wax to white soft paraffin is 2.70 to 10.90 preferably 5 : 83.

3.

4.

4.	» method of preparing an ointment as claimed in claim 1 wherein step (iii) is carried out at temperature <BR> ca<BR> <BR> of 40 C.

5.	A method of preparing an ointment as claimed in <BR> <BR> earlier claims wherein any suitable perfume is added at<BR> a temperature of 30°C and stirring continuously.

6.	The garlic ointment composition for topical use <BR> <BR> substantially as herein described with reference to the<BR> forsaid examples.

7.

A method of preparing ointment for topical use substantially as herein described with reference to the examples described herein. AMENDED CLAIMS [received by the International Bureau on 24 May 2002 (24.05.02); original claims 1, 2, 3 amended; original claims 4, 5, 6 and 7 cancelled ; new claims 8, 9, 10, 11 and 12 added (2 pages)] Amended Claim 1. A method of preparing ointment for topical use comprising the steps of: (i) dispersing the freezed dried garlic powder in the light liquid paraffin in the ratio 1: 5 to 7: 10 (w/w/%), stirring the mixture with a mechanical stirrer to obtain a homogenous mixture. (ii) mixing microcrystalline wax in white soft paraffin in the ratio of 2: 70 to 10: 90 (w/w%), heating the mixture in hot water bath at temperature of 60°to 65° C and stirring the mixture continuously to obtain a homogenous mixture (iii) cooling the mixture prepared in the step (ii) to about 40° C and adding to it the mixture obtained at step (i), stirring the mixtures to obtain a homogenous mixture maintaing the temperature at 4045° C. (iv) cooling the mixture to about 30° C and adding desired quantity of perfume, stirring the mixture to obtain the final product. Amended Claim 2. A method of preparing ointment according to claim lwherein the ratio of dried garlic powder to light liquid paraffin is 1. 5: 10. (w/w%). Amended Claim 3. A method of preparing ointment according to in claim 1 wherein the ratio of microcrystalline wax to white soft paraffin is 5: 83.4 (w/w%).

8.	New Claim.

9.

A method of prepaing ointment for tropical use comprising the steps of: (i) dispersing the freezed dried garlic powder in light liquid paraffin in the ratio 1.5 w/w%, stirring the mixture with a mechanical stirrer to obtain homognous mixture. (ii) adding the mixture of step 1 in a mixing vessel and adding water to it, stirring the mixture till a homogenous mixture is obtained. (iii) celostearyl alcohol and paraffin are melted together and heating to 70° C. (iv) molten mixture of step (iii) is added to the mixture step (ii). (v) cooling and thickening the mixture and adding perfume to it.

10.	New Claim.

11.	A ointment composition for topical use comprising Freeze dried garlic powder 1.50 % w/w White soft paraffin 83.40 % w/w Crocrystalline wax 5.00% w/w Light liqud parafin 10.00% w/w Perfume 0.10% w/w.

12.	New Claim.

13.	A ointment composition for topical use comprising Freeze dried garlic powder 1.5% w/w White soft paraffin 15.0% w/w Light liquid paraffin 6.0% w/w Cetostearyl alcohol 7.2% w/w Cetomacrogol 1.8% w/w Glycerol 5.0% w/w The balance being purified water New Claim.

14.	A ointment composition according to claim 1, whenever used for the treatment of bacterial infection.

15.	New Claim.

16.

A ointment composition according to claim 1, whenever used for the treatment of fungal infection. STATEMENT UNDER ARTICLE 19 (1) Explanation The claims have been amended to make the invention more definitive and explicit. Five new claim have been addd claiming the feature already disclosed in the complete specification. No new feature has been disclosed or added. The scope of the invention has been restricted to the disclosure as disclosed originally.

Description:

TITLE: METHOD OF PREPARING GARLIC OINTMENT AND GARLIC OINTMENT COMPOSIT I ON FOR TOPICAL USE IN SKIN INFECTIONS. IN SKIN INFECTIONS.

Technical Field: The invention relates to Method of preparing Garlic Ointment and Garlic-Ointment composition for external use on infected skin. PRIOR ART/FIELD OF INVENTION: Tablet, Oils, Kyolic forms are already available and traditionally being used as chest plaster, chest rub, compress cold/hot decoction, foot poultice, douche and asnose drops. The present preparation describes the method of preparation of ointment of Garlic. Garlic has been exploited for its medicinal properties since centuries by people and physicians throughout the world. Garlic contains atleast 400 compounds which are unique to it. Of these 400 compounds, atleast 30 compounds are known to have some or the other medicinal properties.

Most of the garlic compounds having medicinal properties are derived from the breakdown of a compound known Allicin, Allicin is an active medicinal compound. The

compounds present in garlic have one or more than one of the following activities. These can be used as an antibiotic, detoxifying agent, as an antioxidant and for lowering of blood sugar and cholesterol levels. It can also be used for liver protection. These are the functions of the compounds which are identifies and had been exploited. There are presently, many unidentified compounds whose functions has not been exploited. Therefore, it is advisable to use garlic as a whole, rather than using its active components selectively, to derive maximum benefits from the medicinal properties of the garlic. Uses of garlic as medicine are quite wide, more than, what are known to the human beings. Garlic has been found to be a broad spectrum antibiotic and is effective in killing variety of gram positive and gram negative bacteria. It does posses a good antifungal and antiparasitic property.

Allicin, one of the main active ingredient of garlic is not a stable molecule. It tends to degrade in the presence of water, acid and base. Hence the conditions inn which allicin is stable are limited. Garlic powder in the present invention is freeze dried to preserve its aill. cin content. Also there are different varieties of garlic being cultivated, which contains different allicin content.

An object of the present invention is to provide a new type of preparation of garlic which is useful for external use on the skin, another object of the present invention is. to provide a stable ointment preparation of garlic, which provide stability to allicin. Still further object of the invention is to provide a process for preparing a preparation as set forth above. These and other objects of the invention will be apparent from the following description.

A topically administrable composition of the invention will preferably be in the form of an ointment. In a further aspect the composition of the present invention will be in the form of a Hydrophobic ointment. When the preparation is applied on the skin, it comes i. n contact with water available on the surface of the skin in the form of perspiration and gets emulsified after rubbing with fingers. In the presence of water, allicin from the garlic is being released and aliin is also being converted into allicin. Suitable hydrophobic ointments are those which are formed from white or yellow soft paraffin with liquid paraffin. The preparation of the present invention can be prepared by dispersing freeze dried garlic powder in the light liquid paraffin with continuous stirring to get homogenous mixture of garlic powder and light liquid paraffin, and admixing the dispersion of garlic powder in liquid paraffin in a mixture of microcrystalline wan

and white soft paraffin at temperature between 40 to 45°C. A mixture of microcrystalline wax and white soft paraffin is prepared by heating the mixture in hot water bath to 60-65°C, and stirring continuously to water a homogenous mixture. A suitable perfume may be added to give pleasant smell to the preparation, after (3 cooling down the above preparation to about 30 C.

According to the invention, the method of preparing garlic ointment for topical use comprises of the following steps :- (i)dispersing the freexed dried garlic powder in the light liquid paraffin with mechanical stirrer to get homogenous mixture of garlic powder and light liquid paraffin in the ratio of 1:5 to 7:10 (w/w %). Preferred ratio is 1. 5 : 10.

(ii) mix microcrystalline wax in white soft paraffin . n the ratio of 2:70 to 10:90 (w/w %). By heating the mixture in hot water bath and continously stirring to get : get a homogeneous mixture of microcrystalline wax and o white soft paraffin at temperature ranges of 60-65 C, preferred ratio is 5:83. 4 (w/w %).

(iii) cooling the mixture prepared in step (ii) to cx 40C and adding the mixture of garlic powder and liiquid paraffin prepared under step (i) above and stirring

continuosuly to get homogeneous mixture, at a temperature o of--4. C. o (iv) cooling down the preparation of step (iii) to 30 C and adding suitable prefume to give pleasant smell using a mechanical stirrer.

DESCRIPTION OF PREFERED EMBODIMENTS: The garlic ointment is based on the properties of garlic, and other constituents of the ointment only as a diluents. Freeze dried garlic ponder acts as an antibateriai and antifungal agent. White soft paraffin, a mixture of semisolid saturated hydrocarbon. gives its emollient property to the preparation and acts as a carrier, Microcrystalline wax is used as a stiffening agent., thereby increasing the consistency of ointment. Light liquid paraffin, a purified mixture of 1 i. c uid saturated hydrocarbon, gives its emollient preoperty to the preparation and act as a carrier for disper-siori of drLAg. dispersion of drug.

Following table shows the percentage weight of the constituents of garlic ointment which have been obtained experimentally and for maximum benefits.

Example 1.

Ingredient Range Preferred (% w/w) (% w/w) Freeze dried garlic Powder. 1-7 1. 50 White soft paraffin 70 - 90 83.40 crocrystalline wax 2 - 10 5.00 Light liquid paraffin 5 - 10 10.00 Perfume 0.05 - 0.15 0.10 STABILITY TESTING OF THE FORMULATION Formulation as described in example I was tested under accelerated conditions for the stability of allicin in the composition. Composition A is the formulation disclosed in the invention and composition B is oil in water emulsion ointment composition.

Table 1 Ingredients Pt B Freeze dried Garlic powder 1.5 % 1.5 % White soft paraffin 83.5 % 15.0 % Light liquid paraffin 10.0 % 6.0 % Microcrystalline wax 5.0 % -- Cetostearyl alcohol - 7.2 % Cetomacrogol - 1.8 % Glycerol - 5.0 % Purified Water - q.s. to 100 %

Each composition was prepared as follows: Composition A is prepared by dispersing freeze dried garlic powder in the light liquid paraffin with continuous stirring to get homogeneous mixture of garlic powder and light liquid paraffin, and admixing the dispersion of garlic powder in liquid paraffin in a mixture of microcrystalline wax and white soft paraffin at temperature between 40 to 45°C. A mixture of microcrystalline wax and white soft paraffin is prepared o by heating the mixture in hot water bath to 60-65 C, and stirring cotinuously to get a homogeneous mixture. Composition 8 is prepared by dispersing freeze dried garlic powder in glycerol to form a smooth homogeneous suspension and this is then added to the stirred water in the mining vessel. Cetostearyl alcohol and paraffin ci are melted together and heated to 70 C. The molten mixture is added to the aqueous component with stirring. Stirring is gradually reduced as the mixture cools and thickens.

- 2 c :} Allicin contenton ageing at 25 C Time in months A B 0 0.0195 % 0.0186 % 2 0.0192 % 0.0173 % 2 0.0192 % 0.0161 % 3 0.0190 % 0.0154 % 6 0.0189 % From the stability data, it is evident that composition Of the present invention (A) is superior to composition D, which is a aqueous base preparation.

Whilethe present invention has been described above with respect to several preferred embodiments thereof, it should of course be understood that it should not be limited only to them but various changes or modifications may be made in any acceptable manner without departing from the spirit and scope of invention as defined by the appended claims.

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