Title of Invention

A PROCESS FOR PREPARING A NEEM OIL BASED WOUND HEALING OINTMENT OR CREAM

Abstract

A process of preparing a neem oil based wound healing ointment or cream. It comprises melting 55 to 80% by weight of an additive base at 40 to 100°C. The additive base melt is mixed with 10 to 20% by weight of neem oil and 5 to 15% by weight of linseed oil under stirring followed by cooling the mixture to 30 to 55 °C. The above mixture is further mixed 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.

Full Text

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 Burjor, 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 the manner in which it is to be performed 1 0 MAR 2005 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- 12th Edition 1996, Publ: Merck & Co Inc, NJ,USA]. OBJECTS OF INVENTION 2 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. 3 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. 4 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 5 i) melting 55 to 80%> by weight of an additive base at 40 to 100°C; ii) mixing 10to20%> by weight of neem oil and 5 to 15%> by weight of linseed oil with the additive base melt under stimng followe 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 12.2% 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 6 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. 7 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 Medicament Time taken to start wound healing in days (Mean ± S.E) Time taken for complete wound healing in days (Mean ± S E) Neem oil 4.13 ±0.61 23.4 ±3.64 Ointment of Example 1 2.66 ±0.33 15.5 ±1.80 Acrilin ointment 2.33 ±0.33 15.33 ±1.05 8 Table 2 Data on wound healing in cattle Medicament Time taken to start wound healing in days (Mean ± S.E) Time taken for complete wound healing in days (Mean±SE) Neem oil 6.21 ± 1.13 39.2 ±4.13 Ointment of Example 1 2.63 ±0.31 27.3 ±1.35 Acrilin ointment 3.00 ±0.26 30.33 ±2.65 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 9 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. 10 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 10to20%> by weight of neem oil and 5 to l5%> 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%o 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. 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; 11 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 12 ABSTRACT A process of preparing a neem oil based wound healing ointment or cream. It comprises melting 55 to 80% by weight of an additive base at 40 to 100°C. The additive base melt is mixed with 10 to 20% by weight of neem oil and 5 to 15% by weight of linseed oil under stirring followed by cooling the mixture to 30 to 55 °C. The above mixture is further mixed 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. 13

Documents:

488-mum-2004-abstract (10-03-2005).pdf

488-mum-2004-abstract(10-3-2005).pdf

488-mum-2004-abstract(granted)-(9-1-2008).pdf

488-mum-2004-abstract.pdf

488-mum-2004-cancelled page (10-03-2005).pdf

488-mum-2004-claim(granted)-(10-03-2005).pdf

488-mum-2004-claims(complete)-(27-4-2004).pdf

488-mum-2004-claims(granted)-(10-03-2005).doc

488-mum-2004-claims(granted)-(9-1-2008).pdf

488-mum-2004-claims.pdf

488-mum-2004-correspondence(10-03-2005).pdf

488-MUM-2004-CORRESPONDENCE(29-08-2008).pdf

488-MUM-2004-CORRESPONDENCE(8-10-2009).pdf

488-mum-2004-correspondence(ipo)-(18-11-2004).pdf

488-mum-2004-correspondence(ipo)-(18-2-2010).pdf

488-mum-2004-correspondence-received-030604.pdf

488-mum-2004-correspondence-received-260404.pdf

488-mum-2004-correspondence-received.pdf

488-mum-2004-descripiton (complete).pdf

488-mum-2004-description(complete)-(27-4-2004).pdf

488-mum-2004-description(granted)-(9-1-2008).pdf

488-mum-2004-form 1(27-04-2004).pdf

488-mum-2004-form 19(07-06-2004).pdf

488-mum-2004-form 2(complete)-(27-4-2004).pdf

488-mum-2004-form 2(granted)-(10-03-2005).pdf

488-mum-2004-form 2(granted)-(9-1-2008).pdf

488-mum-2004-form 2(title page)-(complete)-(27-4-2004).pdf

488-mum-2004-form 2(title page)-(granted)-(9-1-2008).pdf

488-mum-2004-form 26(27-04-2004).pdf

488-mum-2004-form 3(27-04-2004).pdf

488-mum-2004-form 8(07-06-2004).pdf

488-mum-2004-form-1.pdf

488-mum-2004-form-19.pdf

488-mum-2004-form-2.pdf

488-mum-2004-form-26.pdf

488-mum-2004-form-3.pdf

488-mum-2004-form-8.pdf

488-mum-2004-specification(amanded)-(10-3-2005).pdf