FORM 2
THE PATENTS ACT, 1970
As amended by the Patents (Amendment) Act, 2002

COMPLETE SPECIFICATION
(See Section 10; Rule 13)
TITLE
A process for preparing a neem oil based wound healing ointment or cream
APPLICANTS
Godrej Agrovet Limited, Pirojshanagar, Eastern Express Highway, Vikhroli (East), Mumbai 400 079, Maharashtra, India, an Indian Company
INVENTORS
Under Section 28(2) Iyer Ramaswamy, Dr Vyas Brahmanand Ambashankar, Dr Mistry Keki Bamanshaw and Godrej Nadir Burj or, all of Godrej Agrovet Limited, Pirojshanagar Eastern Express Highway, Vikhroli (East), Mumbai 400 079, Maharashtra India, all Indian Nationals
The following specification particularly describes the nature of this invention and
GRANTED
the manner in which it is to be performed /^ /A l/W ( V i—

10-3-2005
ORIGINAL

FIELD OF INVENTION
This invention relates to a process for preparing a neem oil based
wound healing ointment or cream.
PRIOR ART
Antibacterial and antifungal properties of neem oil are known. It is, however, difficult and cumbersome to apply and retain neem oil on the wounds for healing purpose due to the free flowing nature of the oil. Therefore, use of neem oil for wound healing application is inconvenient, cumbersome and time consuming. Regeneration of tissues is an integral part of healing. Activities such as cell proliferation, smoothening of the skin or restoration of the epithelial cells also facilitate healing. Linseed oil, salicylic acid and zinc oxide are reported to possess these activities. Antiseptic properties of salicylic acid and zinc oxide are also reported. [The Merck India - 12* Edition 1996, Publ: Merck & Co Inc, NJ, USA].
OBJECTS OF INVENTION

An object of the invention is to provide a neem oil based wound healing ointment or cream which has improved wound healing properties.
Another object of the invention is to provide a neem oil based wound healing ointment or cream which is easy and convenient to apply on wounds.
Another object of the invention is to provide a neem oil based wound healing ointment or cream which is economical.
Another object of the invention is to provide a neem oil based wound healing ointment or cream which is without side effects and is safe.
Another object of the invention is to provide a process of preparing a neem oil based wound healing ointment or cream which has improved wound healing properties.

Another object of the invention is to provide a process of preparing a neem oil based wound healing ointment or cream which is easy and convenient to apply on wounds.
Another object of the invention is to provide a process of preparing a neem oil based wound healing ointment or cream which is economical.
Another object of the invention is to provide a process of preparing a neem oil based wound healing ointment or cream which is without side effects and is safe.
Another object of the invention is to provide a process of preparing a neem oil based wound healing ointment or cream which is simple, easy and convenient to carry out.
Another object of the invention is to provide a method of treatment of wounds by applying topically the above neem oil based wound healing ointment or cream.

DESCRIPTION OF THE INVENTION
According to the invention there is provided a neem oil based wound healing ointment or cream comprising 10 to 20% by weight of neem oil, 1.5 to 3.0% by weight of zinc oxide, 0.5 to 2.0% by weight of salicylic acid, 0.5 to 2.0%) by weight of potassium nitrate, 5 to 15%) by weight of linseed oil and 55 to 80% by weight of base additive.
Preferably, the additive base comprises bees wax and petroleum jelly in the weight ratio 15 : 40 to 25 : 70
Preferably the wound healing ointment or cream comprises 16.5% by weight of neem oil, 1.5% by weight of zinc oxide, 0.8% by weight of salicylic acid, 0.8% by weight of potassium nitrate, 8.2% by weight of linseed oil and 72.2% by weight of additive base, namely bees wax and petroleum jelly in the weight ratio 23 : 77.
According to the invention there is also provided a process of preparing a neem oil based wound healing ointment or cream comprising the steps of

i) melting 55 to 80%) by weight of an additive base at 40 to
100°C;
ii) mixing 10 to 20%) by weight of neem oil and 5 to 15%o by weight
of linseed oil with the additive base melt under stirring foUowe d by
cooling the mixture to 30 to 55 " C;
(iii) and further mixing the mixture obtained by step (ii)with 1.5 to
3.0%) by weight of zinc oxide, 0.5 to 2.0%) by weight of salicylic acid
and 0.5 to 2.0 % by weight of potassium nitrate under stirring.
Preferably, the process comprises mixing the additive base, namely bees wax and petroleum jelly in the weight ratio 15 : 40 to 25 : 70.
Preferably the process comprises the steps of
ia) melting 72.2% by weight of the additive base namely bees wax
and petroleum jelly in the weight ratio 23 : 77;
iia) mixing 16.5%) by weight of neem oil and 8.2%o by weight of
linseed oil with the additive base melt followed by cooling the mixture
and

iiia) further mixing the mixture obtained by step (iia) with 1.5% by weight of zinc oxide, 0.8% by weight of salicylic acid and 0.8% by weight of potassium nitrate.
Preferably the additive base is melted at 75 ° C.
Preferably the mixture of step (ii) and (iia) is cooled to 40 "C.
Besides bees wax and petroleum jelly other additive bases such as paraffin wax, salts and esters of fatty acids, fatty alcohols or hydrogenated wax may also be used in the ointment or cream of the invention.
According to the invention there is also provided a method of treatment of wounds by applying topically the neem oil based wound healing ointment or cream described above.
The medicament of the invention may be used on any mammalian species.

The following experimental example is illustrative of the invention but not limitative of the scope thereof:
Example 1 Bees wax (16.6 % by weight) and petroleum jelly (55.6% by weight) were melted at 75 °C. Neem oil (16.5% by weight) and linseed oil (8.2% by weight) were added to the melt and stirred well for half an hour. After cooling the mixture to 40°C, zinc oxide (1.5%) by weight), salicylic acid (0.8% by weight) and potassium nitrate ( 0.8%) by weight) were added to it and stirred well for further one hour to form an ointment. The wound healing efficacy of the ointment was studied on fresh wounds in dogs and cattle and the results were as given in the following Tables:
Table 1 Data on wound healing in dogs


Table 2
Data on wound healing in cattle

The frequency of application of the medicaments on the wounds was twice daily namely morning and evening. Acrilin comprising gamma benzene hexachloride, proflavin hemisulphate and cetrimide is a commercially available ointment of M/s. GSK Agrivet, India for wound healing.
It is quite evident from Tables 1 and 2 that the ointment of the invention showed improved wound healing properties as compared to neem oil alone and that the wound healing properties of the ointment of the invention were comparable to those of commercially available ointment namely Acrilin. The ointment of the invention is easy and convenient to apply on wounds. It is economical because neem oil and

the other ingredients are cheap and easily available. The ointment of the invention is also safe and without side effects as the ingredients are without side effects.
Besides being in the form of ointment, the medicament of the invention also may be in the form of a cream. The process of preparing the ointment or cream of the invention is simple, easy and convenient to carry out.

WE CLAIM :
1) A process of preparing a neem oil based wound healing ointment or
cream comprising the steps of
i) melting 55 to 80% by weight of an additive base at 40 to
100°C;
ii) mixing 10 to 20% by weight of neem oil and 5 to 15% by weight
of linseed oil with the additive base melt under stirring followed by
cooling the mixture to 30 to 55 ° C;
(iii) and further mixing the mixture obtained by step (ii) with 1.5 to
3.0 % by weight of zinc oxide, 0.5 to 2.0%) by weight of salicyhc acid
and 0.5 to 2.0 % by weight of potassium nitrate under stirring.
2) A process as claimed in claim 1, which comprises mixing the
additive base, namely bees wax and petroleum jelly in the weight
ratio 15 : 40 to 25 : 70.
3) A process as claimed in claim 1, which comprises the steps of ia) melting 72.2% by weight of the additive base namely bees wax and petroleum jelly in the weight ratio 23 : 77;

iia) mixing 16.5% by weight of neem oil and 8.2% by weight of
linseed oil with the additive base melt followed by cooling the mixture
and
iiia) further mixing the mixture obtained by step (iia) with 1.5% by
weight of zinc oxide, 0.8% by weight of salicylic acid and 0.8% by
weight of potassium nitrate.
4) A process as claimed in anyone of claims 1 to 3, wherein the additive base is melted at 75 ° C.
5) A process as claimed in any one of claims 1 to 4, wherein
mixture of step (ii) or (iia) is cooled to 40 ° C.
6) A process of preparing a neem oil based wound healing ointment
or cream as herein described particularly with reference to Example 1.
Dated this 26th day of April 2004
(Jose M A )
of Khaitan & Co Agent for the Applicants