Title of Invention	A PROCESS FOR PRAPARATION OF INTRAVENOUS LIPID EMULSION
Abstract	The invention relates to a process of preparation of Intravenous iipid emulsion wherein fats rich in long chain potyunsaturated fatty acids is reduced and replaced with medium chain saturated fats supplemented with low level of long chain polyunsaturated fats which reduces the free radical generation and accumulation of fats in organ, including the steps of using prepared sodium oleate solution (B) is mixed with glycerol to obtain prepared sodium oleate - glycerol solution (c), which is mixed with stirrer with prepared Lecithin solution (A) to form emulsifying solution (D), to which coconut oil and sunflower oil are added to obtain oil mixture (E), to which Vitamin E Is added to obtain an emulsion, which further fine emulsion Is obtained by sonification which Is sterilized and stored.

Title of Invention

A PROCESS FOR PRAPARATION OF INTRAVENOUS LIPID EMULSION

Abstract

The invention relates to a process of preparation of Intravenous iipid emulsion wherein fats rich in long chain potyunsaturated fatty acids is reduced and replaced with medium chain saturated fats supplemented with low level of long chain polyunsaturated fats which reduces the free radical generation and accumulation of fats in organ, including the steps of using prepared sodium oleate solution (B) is mixed with glycerol to obtain prepared sodium oleate - glycerol solution (c), which is mixed with stirrer with prepared Lecithin solution (A) to form emulsifying solution (D), to which coconut oil and sunflower oil are added to obtain oil mixture (E), to which Vitamin E Is added to obtain an emulsion, which further fine emulsion Is obtained by sonification which Is sterilized and stored.

Full Text	The present invention relates generally to process of preparation of lipid emulsion. Specifically the present invention relates to lipid emulsion used as Intravenous lipid emulsion. Intravenous Upld emulsion Is a dinical nutrition product falling under the banner c4 ^critical care products'. The major specialities where Intravenous lipid emulsion is used are gastroentBrt^ogy^ oncologYt major surgeries^ trauma^ central nervous system ailments >Mhich results In swttllowing difficulty, malabsorption etc All Intravenous lipid emulsions essendaliyoomprfsecf an aqueous carrier, an emuisifler agent and an oil component. Intravenous lipid emulsion now in use are mostly imported ones and prohibitively costly. Most of these preparations use fiits rfch in long chain fiitty acids particularly, unsaturated fatty acids such as oleic add, linoleic add, linolenic acid and saturated fatty adds like palmitic acid and stearic add. The fats commonly used are soya bean oil^ and sunflower oil. This has two major disadvantages. Firstly It is known that these long chain fiaitty adds lead to accumulation of fit In the organs which Is not desirable. Secondly the polyunsaturated fatty adds present are subfect to lipid peroxidation which results In free radical generation with consequent damage to organs. This damage by free radical is one of the major factors invc^ed in the pathogenesis of several disordanE. SUMMARY QP THE INVgrmftN As is known^ the lipid emulsion are meant to be infused into a person as a dinical nutrition and It Is desired to have minimal damage «»the organs as skle effiBct. Our long experience in this area has revealed that medium chain saturated fat supplemented with low level of long chain pafyunsaturatad fats to satisfy the essential fatty adds requirement, are Ideal for Intravenous lipid Binuislon formulation. Medium and short chain fatty acldsara mfltafaoised In a different way. They are oxidized for energy productian and do not lead to accumulation of fats In organs. More important as saturated fatty adds, they do not undergo lipid peroxidation, with very little free radical generation. In the known prior art, as described above excess free radicals are generated by lipid peroxidation of polyunsaturated fatty acids. These free radicals cause damage to organs. In certain situations^ due to this disadvantage^ it is not desired to prescribe lipid emulsion. QMECT OP THg TilVeilTlON It has been tested and found that lipid emulsion using medium chain saturated fats supplemented with low level of long chain polyunsaturated fats to satisfy the essential fatty acid requirement greatly reduces the free radical generation and accumulation of fat in organ thereby providing an ideal intravenous lipid emulsion formulation. Another object of the Invention Is to pvovide an intravenous lipid emulsion having characteristics such as Improved stability for storage. Another object of the invention is to provide an intravenous iqiid emulsian having characteristics usd'ul in infusion to all patients without any fear of side effects. DEaCMPTIOli Lipid emulsions ar« wall known and are prepared by very many known conventional methods. A lipid emulsion Is a substanttally permanent heterogeneous lk)uld mixtures of two or more liquids that do not normally dissolve in each other, by mechanical agitation or by smal amount of additional substances known as emulslflers. Typically in preparing the emdsionsy the lipkls are added to ethanoi or chloroform or any other suitable organic solvent and agitated by hand or mechanical techniques. 1Tie solvent is then evaporated from the mixture leaving a dried glaze of lipid The Ipfdsare fesuspended in aqueous madia, sucli as phosphate ixrffered saline resulting in an emulsion. To achieve a more homogeneous size distributton of the emulsified lipids, the mixture may be sonicated using com«mk)nalSoiiiftatlontechni(\|ues^ further emulsified using micro fluldisation fusing and /or extruded under high pressure (600 psi) using an extruder device. In preparing the lipid emulsaanj paiHailarty useful addftivtts are Soya bum Ledthln, gluou« und D.L alpha - Tocopheral (Vtaimin Q generally preferred In a particular ratia These additives are particularly usefUi where intravenous applicatJon is desired. It is a well recognized prior art, that any of the lipid compounds and preparation containing the lipid compounds may be lyophilised for storage and reconstituted in, for example, an aqueous medium (such as sterile water or Phosphate buffered saline) with the aid of vigorous agitation. In order to prevent agglutination or fusion of lipids as a result of lyophllization, it may be usehjl to include additivet in the formulation ID prevent such fusion or agglutination. Additives which may be useful include sorbitol, mannitol, sodium diloride, glwxtae, beliakMe, polyvinylpyrrolidone and polyethylene glycol. As per tlte invention, we are reducing in the process of preparation of emulsion, the use of fats rich in long chain polyunsaturated fatty adds and instead are replacing the same with a mixture of medium chain saturaosd 6iC5 supplemented with low level c^ long chain polyunsaturated fats. By this the icnown disadvantage prevalent in the prior art i.e., high amount of fet accumulation in various organs Is appreciably reduced if not toftaiy eliminated The level in the blood of the products of lipid peroxidation from the polyunsaturated fatty acid, i.e. free radicals is appreciably reduced. oils and fills conialnlnfl fatty adds, which are predominantly 16-18 carbons long and contain zero to three double bonds, estsrified togtycerd are referred to as long chain triglycerides. Medium chain fatty acids esterified to glycerol form medium chain triglycerides. Medium chain triglycerides are triglyoeridesmade iivith saturated Cio to Ci4 fatty addsi These shorter chain triglycerides are metabolised differently from long chain triglycerides by the body. The fotty adds generated frcxn the medium chain triglycerides are mainly axidizBd to prcxfide a sourm of quick energy, with consequent decreased deposition of fats In organs. Since they contain very little polyunsaturated ftitty adds, there would less of lipid peroxidation and free radical generation. Incorporation of a small quantity of long chain triglycerides containing polyunsaturated fatty acid along with medium chain trli^cerides has the added advantage that they satisfy the requirement of the essential fatty adds, which are long chain poly unsaturated fatty acid. It was not also not daa r In v lew of pr lor art ttiat when long cha in fatty acids combined with medium chain l^tty adds in a trlglyoeride molecule, that the combination would provide a reduction in free radical gencratloa Aprooesshad to be developed to demonstrate a redudjon in free radicalgeneratkin whidi is part of this invention. Further It has also found that such a mixture of medium chain triglycerides with small amount of long chain triglycerides hasthe advantage of more stable emulsion with smaller partide size. It has been found that long diain fatty acids are metabolised by a pathway different from that of the medium / short chain fatty adds. The long chain fatty adds present in the fats leads to aocumUbitlonoffots in organs whk:h is not desirable and also the polyunsaturated fattf adds present in these fats due to lipid peroxidation result in free radical generation, wvhidi damage the organs. Therefore there Is a need for a fat composition containing trighrcerktes containing long chain polyunsaturated fatty adds and triglycerdes containing saturated medium ctiafn fatty adds, which provide a cUnicaliy nutritionai intravenous lipid emulaian with minimal side effects on the patienL We hereby beiow describe the process oT preparation of intravenous lipid emulsion as per the invention: - As per the invention long chain polyunsaturated fatty add (Ci* - Civ) preferaUy obtained from sunflower oil and medium chainsataualiBd ifeitty adds •re obtained from coconut oil which is rich in Ci» fitty add. A process for preparation of a lipid emulsion for intravenous use comprising an emulsion formulation made of medium chain saturated fat supplemented with low level of long chain polyunsaturated fisits and Vitamin E and an emulsifying agent such that the particle site for emuMon isone mloon or less and the emulsion has osomoballty of 404 mosm/kg water most suitable for intravenous transfusion and comprising of following staps and sequences: - 1. ijBCithin (0.6g Soya lecithin) is added to 45ml of deiontsedy pyrogen free water wtiidi is preheated to 6(yc and nidintained at 6(PC and dissolved by means of a magnetic stirrer tooi>tain Lecithin solution. 2. Sodium deate (0.75g) is added to 45ml of deionised pyrogen free water which is preheated to 60C and maintained at6(yC and dissoh^ed by means cf a magr^tic stirrer to dttainSoditon Oieate solution. a Oycttfol (2.2gm by weight) is added to Sodium Oieate sctlution obtained in step 2, 4. Mixing of Ledthin solution c/f step (1) and Sodium Oieate - glycerol solution of step (3) by means of a magnetic stirrer to obtain the emulsifying solution. 5^ Mixing of coconut oil (6.0g) and sunflower oil (4.0g) to obta in the oil mixture. & Vitamin £ (a - tocoi;Aerol acetate) (2Smg) is added as an antioxidant to the mixture of step 5. 7. ai mixture of step {€) is added drop by drop to emu!sHyln« sofutiGNn of step (4) with infeemiittent stirring using a magra^ stirrer to obtain an emuttnon. a Sonffication of the emulsion from step 6 at €CfC temperature » as to 9t Transfer of emulsion to storage oMitalner " sterile bottle with rubber stopper, poiyoleflne bag or any sulUble container, 10. Starllisation by means of a utodaving of the contents at 15 lbs pressure for 30 minutss. 11, Storing of the emulsion at temperature not exceeding 25C but not less than 8 Th« present invention provides a process for achieving an innproved intravenous lipid emulsion with good nutritional support value but also provides an improved Intravenous lipid emulsion which overcomes the undesired side effects of free radka) generation in the prevtousart Ibe present invention also provides a process for having particle mostly cfsiae of one micron or even tess, a sdze lower than present in majority of the partides in other lipid emulsfons. The present invention provides a process wherein fbrmiriatlon oMnprises of 6g of coconut oil 4g of sunflower oil per 100ml of emulsion. The present invention provide a process where in the formulation mentioned above containing 25mg of vitamin E per lOOmi emulsion, as an antioxidant to prevent the lipid percnidatlon of the poiyunraturated tatty adds (N-esent in sunflower ^i. The present invention provides a process wherein formuiatianaimpriBes of emulsifying agents 0.6g of Soya Ucithin and 0.7Sg of Sodium CHeate per 100ml of emulsion. The ivesent invention provide a pnxBssvvhw«n the emission forniutation contain glycerol (Z 2g) to have osmolality di 404 mosm / Kg water. It fs to be mentioned that various changes and modifcation which will be apparent to those skilled In the art^ without departing from the spirit and scope at present invention witliout diminishing tfieoMhents of inventioiv are also to be covered in this Invention. WE CLAIM 1. A process for preparation of a lipid emulsion for intravenous use comprising an emulsion formulation made of medium chain saturated fat suppiemented with low level of long chain polyunsaturated fats and Vitamin E and an emulsifying agent such that the partide size for emubion is one micron or less and emulsion has osomolarity of 404 mosm / kg water most suitable for Intravenous transmission and comprising of following stops and sequences: - 1 Lecithin is added to 4Sml of deionlsed, pyrogen free water which Is preheated to 60oC and maintained at 60oC and dlssolved by means of a magnetic stirrar to obtain Lecithin solution. 2. Sodium oleats is added to 45ml of deionised,pyrogen free water which is preheated to 60oC and maintained at 60oC and dissolved by means of a magnetic stirrer to obtain Sodium Oleate solution, 3. Glycerol 22g by weight Is added to Sodium Oleate solution obtained in step 2, 4. Mixing of lecithin solution of step (1) and Sodium Oleate glycerd solution of step (3) using a magnetic stirrer to obtain emulsifying solution. 5. Mixing of coconut oil and sunflower oil to obtain the oil mixture, 6. Incorporating vitamin E into the fat mixture from step 5. 7. Oil mixture of step (6) is added drop by drop to emulsifying solution of step (4) with intermittent stirring using a magnetic stirrer. a Soniflcatlon of the contents at 60oC temperature so as to obtain fine emulsion, ft Transfer of emulsion to storage container - sterile bottle with rubber stopper, polyoleflne bag or any suitable container msteriiisatlon by means of autodaving of the contents at 15 i» pressure for 30 minutes. ll.Storing of the emulsion at temperature not exceeding 29C and not less that 8oC. 2. A process for preparation of a lipid emulsion for intravenous use claimed in claim 1 comprising of emulsion wherein oil mixture means coconut oil (6g} and sunflower oil (4g} in combination along with vitamin E (25mg) per 100ml of emulsion. 3. A process for preparation of a lipid emulsion for intravenous use as a daimed in daim 1, comprising an emulsion wherein emulsifying agents ana Soya Ledtliin (0.6g) and Sodium Oleate (0.75g) in combination per 100ml of emulsion. 4. A process for preparation of a lipid emuisian for IntFavenous use as daimed in daim 1, as substantially described in the complete specification.

Full Text

The present invention relates generally to process of preparation of lipid emulsion. Specifically the present invention relates to lipid emulsion used as Intravenous lipid emulsion.
Intravenous Upld emulsion Is a dinical nutrition product falling under the banner c4 ^critical care products'. The major specialities where Intravenous lipid emulsion is used are gastroentBrt^ogy^ oncologYt major surgeries^ trauma^ central nervous system ailments >Mhich results In swttllowing difficulty, malabsorption etc
All Intravenous lipid emulsions essendaliyoomprfsecf an aqueous carrier, an emuisifler agent and an oil component.
Intravenous lipid emulsion now in use are mostly imported ones and
prohibitively costly. Most of these preparations use fiits rfch in long chain fiitty acids particularly, unsaturated fatty acids such as oleic add, linoleic add, linolenic acid and saturated fatty adds like palmitic acid and stearic add. The fats commonly used are soya bean oil^ and sunflower oil. This has two major disadvantages. Firstly It is known that these long chain fiaitty adds lead to accumulation of fit In the organs which Is not desirable. Secondly the polyunsaturated fatty adds present are subfect to lipid peroxidation which results In free radical generation with consequent damage to organs. This damage by free radical is one of the major factors invc^ed in the pathogenesis
of several disordanE.
SUMMARY QP THE INVgrmftN
As is known^ the lipid emulsion are meant to be infused into a person as a dinical nutrition and It Is desired to have minimal damage «»the organs as skle effiBct.
Our long experience in this area has revealed that medium chain saturated fat supplemented with low level of long chain pafyunsaturatad fats to

satisfy the essential fatty adds requirement, are Ideal for Intravenous lipid Binuislon formulation. Medium and short chain fatty acldsara mfltafaoised In a different way. They are oxidized for energy productian and do not lead to accumulation of fats In organs. More important as saturated fatty adds, they do not undergo lipid peroxidation, with very little free radical generation.
In the known prior art, as described above excess free radicals are generated by lipid peroxidation of polyunsaturated fatty acids. These free radicals cause damage to organs. In certain situations^ due to this disadvantage^ it is not desired to prescribe lipid emulsion.
QMECT OP THg TilVeilTlON
It has been tested and found that lipid emulsion using medium chain saturated fats supplemented with low level of long chain polyunsaturated fats to satisfy the essential fatty acid requirement greatly reduces the free radical generation and accumulation of fat in organ thereby providing an ideal intravenous lipid emulsion formulation.
Another object of the Invention Is to pvovide an intravenous lipid emulsion having characteristics such as Improved stability for storage.
Another object of the invention is to provide an intravenous iqiid emulsian having characteristics usd'ul in infusion to all patients without any fear of side effects.
DEaCMPTIOli
Lipid emulsions ar« wall known and are prepared by very many known
conventional methods. A lipid emulsion Is a substanttally permanent heterogeneous lk)uld mixtures of two or more liquids that do not normally dissolve in each other, by mechanical agitation or by smal amount of additional substances known as emulslflers. Typically in preparing the emdsionsy the lipkls
are added to ethanoi or chloroform or any other suitable organic solvent and agitated by hand or mechanical techniques. 1Tie solvent is then evaporated from

the mixture leaving a dried glaze of lipid The Ipfdsare fesuspended in aqueous madia, sucli as phosphate ixrffered saline resulting in an emulsion.
To achieve a more homogeneous size distributton of the emulsified lipids, the mixture may be sonicated using com«mk)nalSoiiiftatlontechni(|ues^ further emulsified using micro fluldisation fusing and /or extruded under high pressure (600 psi) using an extruder device.
In preparing the lipid emulsaanj paiHailarty useful addftivtts are Soya bum
Ledthln, gluou« und D.L alpha - Tocopheral (Vtaimin Q generally preferred In a particular ratia These additives are particularly usefUi where intravenous applicatJon is desired.
It is a well recognized prior art, that any of the lipid compounds and preparation containing the lipid compounds may be lyophilised for storage and reconstituted in, for example, an aqueous medium (such as sterile water or Phosphate buffered saline) with the aid of vigorous agitation.
In order to prevent agglutination or fusion of lipids as a result of lyophllization, it may be usehjl to include additivet in the formulation ID prevent such fusion or agglutination. Additives which may be useful include sorbitol, mannitol, sodium diloride, glwxtae, beliakMe, polyvinylpyrrolidone and polyethylene glycol.
As per tlte invention, we are reducing in the process of preparation of emulsion, the use of fats rich in long chain polyunsaturated fatty adds and instead are replacing the same with a mixture of medium chain saturaosd 6iC5 supplemented with low level c^ long chain polyunsaturated fats. By this the icnown disadvantage prevalent in the prior art i.e., high amount of fet
accumulation in various organs Is appreciably reduced if not toftaiy eliminated The level in the blood of the products of lipid peroxidation from the
polyunsaturated fatty acid, i.e. free radicals is appreciably reduced.

oils and fills conialnlnfl fatty adds, which are predominantly 16-18 carbons long and contain zero to three double bonds, estsrified togtycerd are referred to as long chain triglycerides.
Medium chain fatty acids esterified to glycerol form medium chain triglycerides. Medium chain triglycerides are triglyoeridesmade iivith saturated Cio to Ci4 fatty addsi These shorter chain triglycerides are metabolised differently from long chain triglycerides by the body. The fotty adds generated frcxn the medium chain triglycerides are mainly axidizBd to prcxfide a sourm of
quick energy, with consequent decreased deposition of fats In organs. Since they contain very little polyunsaturated ftitty adds, there would less of lipid peroxidation and free radical generation.
Incorporation of a small quantity of long chain triglycerides containing polyunsaturated fatty acid along with medium chain trli^cerides has the added advantage that they satisfy the requirement of the essential fatty adds, which are long chain poly unsaturated fatty acid.
It was not also not daa r In v lew of pr lor art ttiat when long cha in fatty acids combined with medium chain l^tty adds in a trlglyoeride molecule, that the combination would provide a reduction in free radical gencratloa Aprooesshad to be developed to demonstrate a redudjon in free radicalgeneratkin whidi is part of this invention.
Further It has also found that such a mixture of medium chain triglycerides with small amount of long chain triglycerides hasthe advantage of more stable emulsion with smaller partide size.
It has been found that long diain fatty acids are metabolised by a pathway different from that of the medium / short chain fatty adds. The long chain fatty adds present in the fats leads to aocumUbitlonoffots in organs whk:h is not desirable and also the polyunsaturated fattf adds present in these fats due to lipid peroxidation result in free radical generation, wvhidi damage the organs. Therefore there Is a need for a fat composition containing trighrcerktes containing long chain polyunsaturated fatty adds and triglycerdes containing

saturated medium ctiafn fatty adds, which provide a cUnicaliy nutritionai intravenous lipid emulaian with minimal side effects on the patienL
We hereby beiow describe the process oT preparation of intravenous lipid emulsion as per the invention: -
As per the invention long chain polyunsaturated fatty add (Ci* - Civ) preferaUy obtained from sunflower oil and medium chainsataualiBd ifeitty adds •re obtained from coconut oil which is rich in Ci» fitty add.
A process for preparation of a lipid emulsion for intravenous use
comprising an emulsion formulation made of medium chain saturated fat supplemented with low level of long chain polyunsaturated fisits and Vitamin E and an emulsifying agent such that the particle site for emuMon isone mloon or less and the emulsion has osomoballty of 404 mosm/kg water most suitable for intravenous transfusion and comprising of following staps and sequences: -
1. ijBCithin (0.6g Soya lecithin) is added to 45ml of deiontsedy pyrogen free water wtiidi is preheated to 6(yc and nidintained at 6(PC and dissolved by means of a magnetic stirrer tooi>tain Lecithin solution.
2. Sodium deate (0.75g) is added to 45ml of deionised pyrogen free water which is preheated to 60*C and maintained at6(y*C
and dissoh^ed by means cf a magr^tic stirrer to dttainSoditon
Oieate solution.
a Oycttfol (2.2gm by weight) is added to Sodium Oieate sctlution
obtained in step 2,
4. Mixing of Ledthin solution c/f step (1) and Sodium Oieate -
glycerol solution of step (3) by means of a magnetic stirrer to
obtain the emulsifying solution.
5^ Mixing of coconut oil (6.0g) and sunflower oil (4.0g) to obta in
the oil mixture.
& Vitamin £ (a - tocoi;Aerol acetate) (2Smg) is added as an
antioxidant to the mixture of step 5.

7. ai mixture of step {€) is added drop by drop to emu!sHyln«
sofutiGNn of step (4) with infeemiittent stirring using a magra^
stirrer to obtain an emuttnon.
a Sonffication of the emulsion from step 6 at €CfC temperature »
as to 9t Transfer of emulsion to storage oMitalner " sterile bottle with
rubber stopper, poiyoleflne bag or any sulUble container,
10. Starllisation by means of a utodaving of the contents at 15 lbs
pressure for 30 minutss.
11, Storing of the emulsion at temperature not exceeding 25*C but
not less than 8 Th« present invention provides a process for achieving an innproved intravenous lipid emulsion with good nutritional support value but also provides an improved Intravenous lipid emulsion which overcomes the undesired side effects of free radka) generation in the prevtousart Ibe present invention also provides a process for having particle mostly cfsiae of one micron or even tess, a sdze lower than present in majority of the partides in other lipid emulsfons.
The present invention provides a process wherein fbrmiriatlon oMnprises of 6g of coconut oil 4g of sunflower oil per 100ml of emulsion.
The present invention provide a process where in the formulation
mentioned above containing 25mg of vitamin E per lOOmi emulsion, as an antioxidant to prevent the lipid percnidatlon of the poiyunraturated tatty adds (N-esent in sunflower ^i.
The present invention provides a process wherein formuiatianaimpriBes of emulsifying agents 0.6g of Soya Ucithin and 0.7Sg of Sodium CHeate per
100ml of emulsion.
The ivesent invention provide a pnxBssvvhw«n the emission forniutation contain glycerol (Z 2g) to have osmolality di 404 mosm / Kg water.

It fs to be mentioned that various changes and modifcation which will be apparent to those skilled In the art^ without departing from the spirit and scope at present invention witliout diminishing tfieoMhents of inventioiv are also to be
covered in this Invention.

WE CLAIM
1. A process for preparation of a lipid emulsion for intravenous use comprising
an emulsion formulation made of medium chain saturated fat suppiemented with low level of long chain polyunsaturated fats and Vitamin E and an emulsifying agent such that the partide size for emubion is one micron or less and emulsion has osomolarity of 404 mosm / kg water most suitable for Intravenous transmission and comprising of following stops and sequences: -
1 Lecithin is added to 4Sml of deionlsed, pyrogen free water which Is preheated to 60oC and maintained at 60oC and dlssolved by means of a
magnetic stirrar to obtain Lecithin solution. 2. Sodium oleats is added to 45ml of deionised,pyrogen free water which is
preheated to 60oC and maintained at 60oC and dissolved by means of a
magnetic stirrer to obtain Sodium Oleate solution, 3. Glycerol 22g by weight Is added to Sodium Oleate solution obtained in
step 2, 4. Mixing of lecithin solution of step (1) and Sodium Oleate glycerd solution
of step (3) using a magnetic stirrer to obtain emulsifying solution. 5. Mixing of coconut oil and sunflower oil to obtain the oil mixture, 6. Incorporating vitamin E into the fat mixture from step 5. 7. Oil mixture of step (6) is added drop by drop to emulsifying solution of
step (4) with intermittent stirring using a magnetic stirrer.
a Soniflcatlon of the contents at 60oC temperature so as to obtain fine
emulsion, ft Transfer of emulsion to storage container - sterile bottle with rubber
stopper, polyoleflne bag or any suitable container msteriiisatlon by means of autodaving of the contents at 15 i» pressure for
30 minutes. ll.Storing of the emulsion at temperature not exceeding 29*C and not less
that 8oC.
2. A process for preparation of a lipid emulsion for intravenous use claimed in
claim 1 comprising of emulsion wherein oil mixture means coconut oil (6g} and

sunflower oil (4g} in combination along with vitamin E (25mg) per 100ml of emulsion.
3. A process for preparation of a lipid emulsion for intravenous use as a daimed
in daim 1, comprising an emulsion wherein emulsifying agents ana Soya Ledtliin
(0.6g) and Sodium Oleate (0.75g) in combination per 100ml of emulsion.
4. A process for preparation of a lipid emuisian for IntFavenous use as daimed in
daim 1, as substantially described in the complete specification.

Documents:

093-che-2003-abstract.pdf

093-che-2003-claims filed.pdf

093-che-2003-claims grant.pdf

093-che-2003-correspondnece-others.pdf

093-che-2003-correspondnece-po.pdf

093-che-2003-description(complete) grant.pdf

093-che-2003-description(complete)filed.pdf

093-che-2003-form 1.pdf

093-che-2003-form 19.pdf

093-che-2003-form 26.pdf

093-che-2003-form 5.pdf

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Patent Number

201635

Indian Patent Application Number

93/CHE/2003

PG Journal Number

30/2009

Publication Date

24-Jul-2009

Grant Date

Date of Filing

04-Feb-2003

Name of Patentee

TERUMA PENPOL LIMITED

Applicant Address

T.C. 9/1323, SASTHAMANGALAM, TRIVANDRUM 695010, KERALA, INDIA

Inventors:

#	Inventor's Name	Inventor's Address
1	PARAMESWARA ACHUTHA KURUP	DIRECTOR, R&D, TERUMO PENPOL LIMITED, INDIA
2	DAMAYANTHI DEEPA	SCIENTIST GRADE II, R&D, TERUMO PENPOL LIMITED, INDIA

PCT International Classification Number

A61K9/10

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA