CLIAMS:1. A process of preparing essliver forte injection comprising following steps
- collect fresh, required qty of water for injection of approximate 85 + 5 C in SS Vessel and send water for injection sample to QC for endotoxin & complete testing;
- after approval of WFI take 65% of WFI of batch size and flush the nitrogen for 15 mintes;
- cool down the WFI to 35 C with the help of cooled water supply to jacketed tank circulation;
- add & dissolve sodium deoxycholate 13.75 Kg and run the stirred for 15 min with continuous nitrogen flushing;
- dissolve required quantity of essential phosholipids with continuous stirring and nitrogen flushing for 30 minutes;
- add 2.475 Kg benzyl alcohol under continuous stirring & nitrogen flushing for 15 min;
- add 12.750 kg propylene glycol under continues stirring and nitrogen flushing for 15 minutes;
- add previously dissolved 27500 gm vitamin E, 2.750 gm BHT and 0.825 gm BHA in 1.000 Kg of propylence glycol in separate SS vessel to mfg tank under continuous stirring & nitrogen flushing for 15 min;
- add 27.500 Kg Riboflavin sodium phosphate under continuous stirring and nitrogen flushing for 10 minutes;
- adjust the volume to approximately 100 liter with WFI.
2. A process of preparing essliver forte injection as claimed in claim 1 wherein the PH is to be between 7-9 by using sodium hydroxide.

3. A process of preparing essliver forte injection as claimed in claim 2 wherein the solution is then made upto the desired final volume with WFI.

4. A process of preparing essliver forte injection as claimed in claim 1 wherein such preparation are readily sterile filtered for filling into ampoules.
,TagSPECI:FORM 2
THE PATENT ACT 1970
(39 of 1970) &
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
A process of preparing essliver forte injection
2. APPLICANT (S)
(a) Nabros Pharma Private Limited
(b) Nabros Tower Opposite Art Galary,
Behind British Library, Law Garden,
Ellisbridge, Ellisbridge, Ahmedabad,
Gujarat 380006
(c) Indian

The following specification particularly describes the invention and the manner in which it is to be performed.

Field of the Invention
The present invention relates to process of preparing essliver forte injection 5ml which contains essential phospholipids 50mg/ml i.e. 250 mg/5ml injection contains pure phospholipids which contains 73 to 79 % phosphatidylcholine/ Deoxycholate.

Background of the Invention
Phospholipids being natural fat, break down fat and lower total cholesterol level at the same time increase HDL level, which is essential for normal heart function. Essliver forte injection provides the diseased liver- the metabolic activities of which are impaired with a high dosage of readily utilizable high energy “essential” phospholipids. These “essential” phospholipids as phosphatidylcholine ideally correspond to the vital endogenous phospholipids in terms of chemical structure, but are even superior to the latter from the functional point of view. They are mainly transported into the liver cells, incorporated as intact molecules into the membranes of these cells and their organeless and in addition, they are secreted with the bile. Essliver forte injection thus physiologically.

Various studies conducted in many countries reveals that use of essential phospholipids (phosphatidylcholine 73 to 79 %) in injection from helps combating major illness like coronary heart disease, cirrhosis degenerating neurological disorder. These impressive finding pushed the German Health Authorities to publish another monograph on phospholipids. Purified soybean phosphatidylcholine (73- 79 %) has been given drug status as liver therapeutic substance.

To overcome such limitation in the present invented process for preparing essliver forte injection for intravenous from phosphatidylcholine which contains 73 to 79 % phosphatidylcholine is used.

Object of the Invention
The main object of the present invention it to, Normalizes disordered liver functions and enzyme activities by directly influencing the membrane structures;
The further object of the invention it to relives the energy balance of the liver;
The further object of the invention is to promotes the regeneration of the liver tissues;
The further object of the invention is converts neutral fats and cholesterol into transportable forms and makes them available for combustion;
The present invented process is stabilizes the bile;
The essliver forte injection used in Hepatopathies of any origin, hepatitis, chronic hepatitis, necrosis of the liver, cirrhosis, pre-coma, coma, fatty liver (also in diabetes) , cholestasis, intoxication, prophylaxis of gallstone recidivation; pre and post operative treatment , especially in hepatobilliary surgery; gestoses including hyperemesis; psoriasis, neurodermatitis, radiation syndrome.

Essential Phospholipid (Phosphatidylcholine) in injection form is commercial viable.
Summary of the Invention
The manufacturing process for preparing step comprising following steps
- The 4.2% w/v amount of deoxycholic acid is dissolve in 70- 80% of the final volume of water for injection at 35 C. Make the 1N solution of sodium hydroxide in water & cool the solution. Mix both solutions 0.9% w/v with continuous nitrogen flushing.
- Solid phosphatidylcholine is added with continuous stirring and nitrogen flushing.
- Benzyl alcohol is added under continuous stirring and nitrogen flushing.
- Propylene glycol is added under continuous stirring and nitrogen flushing.
- Add previously dissolved quantity of vitamin E liquid, Butylated Hydroxy Tolune and Butylated Hydroxy Anisole in 1 Kg propylene glycol under continuous stirring and nitrogen flushing.
- Adjust the volume approximately 15lts with WFI under nitrogen flushing for volume making.
- The batch was allowed to stand overnight if a clear solution had not been obtained within few hours.
- The PH is to be between 7-9 by using sodium hydroxide
- The solution is then made upto the desired final volume with WFI.
- Such preparation are readily sterile filtered for filling into ampoules.

BRIEF DESCRIPTION OF THE DRAWINGS
It will be convenient to further describe the present invention with respect to the accompanying drawings that illustrate possible manufacturing process steps of the invention. Other method of the invention are possible, and consequently the particularity of the accompanying drawings is not intended to be limiting of the present invention.
Fig.1 process flow diagram of the present invention manufacturing method

Detailed description of the invention
Before explaining the present invention in detail, it is to be understood that the invention is not limited in its application to the details of the construction and arrangement of parts illustrated in the accompanying drawings. The invention is capable of other embodiments, as depicted in different figures as described above and of being practiced or carried out in a variety of ways. It is to be understood that the phraseology and terminology employed herein is for the purpose of description and not of limitation.
The manufacturing process for preparing step as shown in Fig.1 comprising following steps
- The 4.2% w/v amount of deoxycholic acid is dissolve in 70- 80% of the final volume of water for injection at 35 C. Make the 1N solution of sodium hydroxide in water & cool the solution. Mix both solutions 0.9% w/v with continuous nitrogen flushing.
- Solid phosphatidylcholine is added with continuous stirring and nitrogen flushing.
- Benzyl alcohol is added under continuous stirring and nitrogen flushing.
- Propylene glycol is added under continuous stirring and nitrogen flushing.
- Add previously dissolved quantity of vitamin E liquid, Butylated Hydroxy Tolune and Butylated Hydroxy Anisole in 1 Kg propylene glycol under continuous stirring and nitrogen flushing.
- Adjust the volume approximately 15lts with WFI under nitrogen flushing for volume making.
- The batch was allowed to stand overnight if a clear solution had not been obtained within few hours.
- The PH is to be between 7-9 by using sodium hydroxide
- The solution is then made upto the desired final volume with WFI.
- Such preparation are readily sterile filtered for filling into ampoules.

While, the invention has been described with respect to the given embodiment, it will be appreciated that many variations, modifications and other applications of the invention may be made. However, it is to be expressly understood that such modifications and adaptations are within the scope of the present invention, as set forth in the following claims.

We CLAIM:

1. A process of preparing essliver forte injection comprising following steps
- collect fresh, required qty of water for injection of approximate 85 + 5 C in SS Vessel and send water for injection sample to QC for endotoxin & complete testing;
- after approval of WFI take 65% of WFI of batch size and flush the nitrogen for 15 mintes;
- cool down the WFI to 35 C with the help of cooled water supply to jacketed tank circulation;
- add & dissolve sodium deoxycholate 13.75 Kg and run the stirred for 15 min with continuous nitrogen flushing;
- dissolve required quantity of essential phosholipids with continuous stirring and nitrogen flushing for 30 minutes;
- add 2.475 Kg benzyl alcohol under continuous stirring & nitrogen flushing for 15 min;
- add 12.750 kg propylene glycol under continues stirring and nitrogen flushing for 15 minutes;
- add previously dissolved 27500 gm vitamin E, 2.750 gm BHT and 0.825 gm BHA in 1.000 Kg of propylence glycol in separate SS vessel to mfg tank under continuous stirring & nitrogen flushing for 15 min;
- add 27.500 Kg Riboflavin sodium phosphate under continuous stirring and nitrogen flushing for 10 minutes;
- adjust the volume to approximately 100 liter with WFI.
2. A process of preparing essliver forte injection as claimed in claim 1 wherein the PH is to be between 7-9 by using sodium hydroxide.

3. A process of preparing essliver forte injection as claimed in claim 2 wherein the solution is then made upto the desired final volume with WFI.

4. A process of preparing essliver forte injection as claimed in claim 1 wherein such preparation are readily sterile filtered for filling into ampoules.
For,
Nabros Pharma Private Limited

________________________
Shah Navnit Mulchand