Title of Invention

NOVEL OMEGA -3 FATTY ACID COMPOSITION WITH SIGNIFICANTLY REDUCED OFFENSIVE ODOUR AND PROCESS FOR ITS PREPARATION

Abstract

The invention disclosed in this application relates to novel omega-3 fatty acid composition with significantly reduced offensive odour. The process involves mixing thoroughly an omega-3 fatty acid composition with a buffer containing phospholipase, trypsin and calcium chloride under continuous agitation, separating the resulting oil phase from the buffer, washing the oil phase with water containing sodium ethylene diamine tetra acetic acid (EDTA) under continuous agitation and separating the oil phase from water phase. The invention also relates to a stable powders, tablets, beadlets forms of the above composition.

Full Text

FORM 2 THE PATENTS ACT 70 (Act 39 of 70) COMPLETE SPECIFICATION ( See Section 10) NOVEL OMEGA-3 FATTY ACID COMPOSITION WITH SIGNIFICANTLY REDUCED OFFENSIVE ODOUR AND PROCESS FOR ITS PREPARATION OMNIACTIVES HEALTH TECHNOLOGIES PVT LTD., having its registered office located at Rajan House, Appasaheb Marathe Marg, Prabhadevi, Mumbai 400025, Maharashtra, India The following description particularly describes the nature of the invention and the manner in which it is to be performed Field of the invention The present invention relates to novel omega-3 fatty acid composition with significantly reduced offensive odour and process for its preparation. The present invention, particularly relates to novel omega-3 fatty acid composition containing docosahexaenoic acid and /or eicosapentaenoic acids as omega-3 fatty acid. , tocopherol, sugar, hydroxy propyl methyl cellulose, shellac and a flavour. More particularly, the present invention relates to novel free flowing omega-3 fatty acid composition with significantly reduced offensive odour. The novel free flowing -3 fatty acid composition with significantly reduced offensive odour of the present invention is useful for formulating dry mixes, tablets, capsules, and Heaps,. More particularly, the novel omega-3 fatty acids composition with significantly reduced offensive odour is useful in good eye/brain health in children and adults. Prior art Omega 3 fatty acids are poly-unsaturated fatty acids. Studies show that a diet rich in omega 3 fatty acids may help lower triglycerides and increase HDL cholesterol (the good cholesterol). Omega 3 fatty acids may also act as an anticoagulant to prevent blood from clotting. Several other studies also suggest that these fatty acids may help lower high blood pressure. Omega-3 fatty acids are known to significantly reduce levels of triglycerides, very low density lipoproteins, cholesterol and low density lipoproteins in normal and hyperlipidemic subjects. Omega-3 fatty acids occur in nature in oils extracted from fish and algae. Omega-3 fatty acids may also be obtained by chemically or enzymatically converting omega-6 or omega-9 fatty acids occurring in natural products. Omega-3 and omega-6 fatty acids are essential for the body because they are not synthesized by the body and must be obtained through diet or supplementation. Through an inefficient enzymatic process of desaturation (the rate of conversion is less than 1 percent), ALA produces EPA (20 carbons) and DHA (22 carbons), precursors to a group of eicosanoids (prostaglandins, thromboxanes, and leukotrienes) that are antiinflammatory, antithrombotic, antiarrhythmic, and vasodilatory. The longer chain fatty acid derivative of linoleic acid is arachidonic acid (20 carbons), which is a precursor to a different group of eicosanoids that are proinflammatory and prothrombic. ALA and linoleic acid use and compete for the same enzymes in the production of their longer chain fatty acids, EPA, and arachidonic acid. The ingestion of fish and fish oil provides EPA and DHA directly, therefore avoiding the competition for enzymes to convert ALA to EPA. Research carried out in respect of omega-3 fatty acid composition suggests that including omega-3 fatty acid composition in the food and dietary supplements may: • reduce inflammation, • help prevent blood from clotting and sticking to artery walls, • help to lower the risk for blocked blood vessels and heart attacks, • prevent hardening of the arteries, • decrease the risk of sudden death and abnormal heart rates, • decrease triglyceride levels, • improve overall heart health, and • lower blood pressure. Fish oils are a rich source of the Omega -3 oils DHA(Docosahexaenoic Acid) and EPA(Eicosapentaenoic Acid), which are associated with eye/brain health and cardiovascular well-being respectively. Unfortunately omega-3 fatty acids obtained through these natural sources have very unpleasant odour and taste. Due to this fact, omega-3 fatty acids are currently not formulated in the form of chewable tablets, tablets, hard gelatin capsules and dry mixes. Another major draw back of fish oil composition containing Omega-3 fatty acids is the fishy burp which results after oral ingestion. Due to this drawback, the composition of fish oil containing Omega-3 fatty acids incorporated in soft gelatin capsule is not preferred. Upon oral ingestion, the fish oil gets released in to the stomach and the obnoxious odour is felt during burping. Numerous prior art references are available that describe the processes adopted for the removal of fishy odour from the omega-3 fatty acid compositions . US Patent no. 4895725 provides a process for the microencapsulation of fish oil in non-oil-soluble enteric coating material to remove the obnoxious odour . US patent no. 4853247 describes a method of overcoming the fishy odour offish oil by adding a odor masking agent such as lime, orange or cinnamon. US patent no. 5853761 describes a method of masking the fishy odour in the fish oil by mixing with calcium gluconate. GB 452682, GB 465111 and GB 189816896 teach a method of improving the odour, taste and consistency of triglycerides of fatty acids of fish by fermenting with yeast. The fermentation with yeast & sugar imparts a special flavour to the end product. The yeast flavour helps to mask the fishy odour on the resulting product to a certain extent_ US patent no 5693835 provides a method of hydrogenation for reducing the fishy odour. US patent no 4780309 describes a method of preparing edible aerosol foam composition containing inorganic complexing agent and sensory masking agent. Such a process is employed for masking the fishy odour of the fish oil by mixing the fish oil with an inorganic complexing agent and with flavour)_ US patent no. 4855154 provides a method for deodorizing fish oil using siliceous molecular sieves. US patent application no. 20060068019 describes a method of coating the particles containing the PUFA (Poly Unsaturated Fatty Acid) for reducing the fishy odour. WO 01174175 discloses a method for the encapsulation of food ingredients for the purpose of preventing oxidation. Such a process is employed for masking of fishy odour in fish oil composition by encapsulating it with conventional coating materials_ Shahidi et al provide a review of the art of microcoating of food ingredients (Critical Reviews in Food Science and Nutrition, 33(6): 501-547(1993) This process is also employed for masking fishy odour by coating the products containing fish oil_ Japanese patent no. J56169-622 provides a process for preparing a solid drug containing ingredient by absorbing the oily liquid and a non-ionic surfactant on a granular powder such as aluminium magnesium hydroxide or its derivatives. Such a process is employed for masking of fishy odour by absorbing fish oil along with a surfactant in to a granular powder such as aluminium magnesium hydroxide)_ US patent no. 5693358 describes a method of removing odour from fish oil by treating it with urea and monosodium glutamate. While the above prior art disclosuers provide a wide range of processes for the reduction of offensive odour but all of them employ the masking as a technique to reduce the fishy odour in a fish oil composition containing omega-3 fatty acids . None of these prior art processes are adequate for significantly or complete removal of the offensive odour from the fish oil. Further the resulting product is not suitable for making it in different forms such as tablets, chewable tablets, infant food mixes, two-piece hard gelatin capsules etc. Upon storage, within the tablets or capsules, the odour of fish gets significantly high as the omega-3 fatty acids undergo atmospheric oxidation leading to regeneration of fresh fishy odour Due to the increased recognition of the importance of omega-3 fatty acid compositions in the medical/nutritional field, for its various uses such as lowering triglycerides and increase HDL cholesterol (the good cholesterol), its activity as an anticoagulant which prevents blood from clotting and helping in lower high blood pressure, omega-3 fatty acid compositions are great demand. Having significantly reduced the offensive odour, if the composition also has a higher storage as well as operational stability, it will be beneficial to the formulators of food and nutritional products. Therefore there exists a need for developing a process for significantly reducing the offensive odour to the fish oil and / or omega-3 fatty composition . Objectives of the present invention: Therefore, the main objective of the present invention is to provide novel omega-3 fatty acids composition which has significantly reduced offensive odour. Another objective of the present invention is to provide novel Omega-3 fatty acid composition which has significantly reduced offensive odour that can be converted into tablets / capsules / beadlets / soft or two-piece hard gelatin capsule or a sachet. The present invention has been developed based on our finding that the impurities such as phospholipids and aliphatic amines present in the fish oil / omega-3 fatty acid composition originate from marine oils and algae. Elimination of such impurities will significantly reduce the fishy odour from the fish oil or algal oil extracts or omega-3 fatty acid composition. We have found that Phospholipids which are present in small quantities in fish oil can be effectively removed by the treatment of enzymes such as Phospholipase A in the presence of calcium ions. Additionally, amine and protein impurities present in the fish oils can be eliminated by the treatment of enzyme such as trypsin. A metal chelating agent can also be included in these enzyme reactions to trap impurities such as mercury and arsenic. Thus, by carrying out an enzyme treatment of naturally occurring fish oil with these enzymes in the presence of a metal chelating agent, will produce a composition which is substantially free from impurities that cause fishy odour and which destabilize the omega-3 fatty acids The significantly reduced or odour-free omega-3 fatty acid composition can be further formulated in to dry delivery forms such as powder, beadlets, tablets and the like. The fishy odour can be further reduced with the addition of conventional odour masking agents known in the art. Coating of powders, beadlets and tablets with odour masking agents, as known in the art, will further reduce the fishy odour. Accordingly the present invention provides a novel omega-3 fatty acid composition with significantly reduced offensive odour According to another embodiment of the present invention there is provided a novel omega-3 fatty acid composition with significantly reduced offensive odour in the form stable free flowing stable powders, beadlets, or tablets. According to the present invention there is provided a process for the preparation of the novel omega-3 fatty acids composition which has significantly reduced offensive odour, which comprises (i) mixing thoroughly by heating at a temperature in the range of 35 to 38 Degree C for a period in the range of 10 to 20 hrs , an omega-3 fatty acid composition with a buffer containing phospholipase , trypsin and calcium chloride under continuous agitation, (ii) Separating the resulting oil phase from the buffer, (iii) Washing the oil phase with water containing Sodium Ethylene Diamine Tetra Acetic acid (EDTA) under continuous agitation and, (iv) Separating the oil phase from water phase to obtain omega-3 composition having significantly reduced odour. In another preferred embodiment, the omega-3 fatty acid composition employed in the process may be derived from fish, algae or plant source. The composition may comprise of 0-90% docosahexaenoic acid (DHA) and/or 0-90% eicosapentaenoic acid (EPA). These acids may be in an esterified form. The buffer used may be selected from a group of citrate, phosphate, borate type in the pH range of 3.5-8.5. The another preferred embodiment, the phospholipase used in step (i) may be derived from animal or microbial origin. The phospholipase may be selected from a group comprising phospholipase A, Al, A2, B, C and D.. In a preferred embodiment of the invention the composition resulting from step (iv) may be mixed with a solution containing a binder and a stabilizer and then formed into beadlets by conventional methods . The preferred method of converting into beadlets may be by coating on to sugar spheres in a fluid bed coater to form beadlets The binder used during beadlet preparation may be selected from a group comprising gelatin, starch, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone and the mixtures thereof. In a preferred embodiment, the stabilizer used during beadlet preparation may be selected from a group comprising of ascorbic acid, mixed natural tocopherols, ascorbyl palmitate and mixtures thereof. In another preferred embodiment of the invention the beadlets obtained as above may be coated with a protective polymer along with a odour masking agent and drying the coated omega-3 beadlets at a temperatures not exceeding 45-48 deg to form a coated beadlet, In yet another preferred embodiment, the polymer used for giving protective coating may be selected from a group comprising of methacrylate copolymers, hydroxypropyl methyl cellulose phthalate, shellac, shein, cellulose acetate phthalate. The odour masking agent used may be a flavour selected from mango, pineapple, vanilla, strawberry, mixed fruit, orange, lemon and rose. Detailed description of the invention: In the present invention, the omega-3 fatty acid composition is treated with certain enzymes to eliminate some impurities that cause obnoxious odour. These impurities, such as phospholipids and aliphatic amines, undergo chemo-enzymatic changes in presence of enzymes such as phospholipases and trypsin, respectively and lead to the formation of a omega-3 fatty acid composition which has a significantly reduced obnoxious odour. There are numerous types of phospholipases available that can be used for the purification of oils containing omega-3 fatty acids. The important phospholipases that can be used for reducing the odour of omega-3 fatty acid- containing oils are phospholipase A, Al, A2, B, C and D. For the optimum activity of these enzymes, a suitable buffer is essential. The buffers that can be used may be citrate, borate or phosphate type in a pH range of 3.5 to 8.5. The removal of phospholipids impurities by phospholipase is assisted by the presence of adequate quantities of calcium ions. The omega-3 fatty acid composition can be further purified by treatment with trypsin to eliminate protein and amine impurities and finally with EDTA to chelate metallic impurities. These steps of purifications help in substantial reduction in fishy odour of omega-3 fatty acid composition. Omega-3 fatty acid compositions are highly unstable in presence of air, oxygen and light. To protect the omega-3 acid compositions from environmental degradation, a number of protective antioxidants can be used. Most commonly, plant tocopherols are preferred for this purpose. Tocopherols are available in different isomeric forms. It is preferable to use a mixture of alpha, beta, gamma and delta tocopherols(mixed natural tocopherols) for achieving longer stability. The omega-3 fatty acid composition of the present invention can be converted in to powder, granules, beadlets or pellets by techniques known in the art. The most preferred technique is to coat the omega-3 fatty acid composition on to sugar spheres, with size ranging from 150 microns to 2000 microns either in a coating pan or by using fluid bed technology. This technique provides a free flowing beadlets of uniform size. The omega-3 fatty acid composition of the present invention can be further protected from the environmental oxygen by coating such products with polymers such as hydroxyl propyl methyl cellulose, hydroxyl propyl cellulose, polyvinyl pyrrolidone, ethyl cellulose, methacrylate copolymers, shellac, cellulose acetate phthalate, shein and the like.. Such protective polymers can be applied using techniques such as pan coating, fluid bed coating, powder coating etc. The most preferred method of coating is the one makes use of Wurster technique, wherein, the coating polymer is applied by bottom spray in a fluid bed of pellets or beadlets. The amount of coating polymer applied as coating can range from 30% by weight of the beadlets to 60% by weight of the beadlets. The polymer used for protecting the omega-3 fatty acid composition may also be used to control the release of omega-3 fatty acid within the gastro-intestinal tract. By delaying the release of omega-3 fatty acid, it is possible to reduce the fishy burps upon oral ingestion of such preparation. The organoleptic properties of omega-3 fatty acid composition of the present invention can be further improved with the inclusion of a suitable flavouring agent. Conventionally, pineapple, orange, lemon, mango, vanilla, strawberry flavours are used to improve the organoleptic properties of beadlets containing omega-3 fatty acid composition. Preferably, the flavouring agents are included in the coating medium used for providing environmental protection. The invention is described in detail in the examples given below which are provided to illustrate the invention only and therefore should not be construed to limit the scope of the invention Example 1 50 g of oil containing omega-3 fatty acids( 60% DHA and 15% EPA is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St.Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 10 hrs at 36 degC. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then separated from the water phase to obtain omega-3 fatty acid composition, with significantly reduced odour. Example 2 50 g of oil containing omega-3 fatty acids( 10% DHA and 65% EPA is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 14 hrs at 36 degC. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 25 g hydroxyl propyl methyl cellulose 15 CPS in a mixture of 75 g of dichloromethane and 30 g of isopropyl alcohol to get a composition having significantly reduced offensive odour . The solution containing oil phase is then sprayed on 150g of sugar spheres taken in a fluidbed coater with bottom spray mechanism, at 45 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with aqueous suspension of 0.5 kg of methacrylate copolymers at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated beadlets at 45-48 deg C for 30 min. Example 3 50 g of oil containing omega-3 fatty acids( 90% DHA) is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 30 microgram of Phospholipase A( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 12 hrs at 38 deg C. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 35 g polyvinyl pyrrolidone K-30, in 150g of isopropyl alcohol to get a composition having s9ignificantly reduced offensive odour. The solution containing oil phase is then sprayed on 150g of sugar spheres taken in a fluidbed coater with bottom spray mechanism, at 45 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with aqueous suspension of 0.5 kg of methacrylate copolymers at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated beadlets at 45-48 deg C for 30 min. Example 4 50 g of oil containing omega-3 fatty acids( 70% DHA and 15% EPA is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 18 hrs at 36 degC. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 25 g hydroxyl propyl methyl cellulose 15 CPS in a mixture of 85 g of dichloromethane and 35 g of isopropyl alcohol to get a composition having s9ignificantly reduced offensive odour. The solution containing oil phase is then sprayed on 150g of sugar spheres taken in a fluidbed coater with bottom spray mechanism, at 45-47 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with 30% aqueous suspension of 0.5 kg of Shellac and 30g of mixed fruit flavour at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated beadlets at 45-48 deg C for 30 min. Example 5 50 g of oil containing omega-3 fatty acids( 60% DHA and 15% EPA obtained from algae) is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 10 hrs at 36 deg C. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 25 g hydroxyl propyl methyl cellulose 15 CPS in a mixture of 45 g of dichloromethane and 20 g of isopropyl alcohol to get a composition having significantly reduced offensive odour. The solution containing oil phase is then sprayed on 150g (800-1200 micron size) of sugar spheres taken in a coating pan, at 45 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with 30% aqueous suspension of 0.5 kg of methacrylate copolymers at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated pellets at 45-48 deg C for 30 min. Example 6 50 g of oil containing omega-3 fatty acids( 60% DHA and 15% EPA is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1 % calcium chloride. The stirring is continued for 18 hrs at 36 degC. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 25 g hydroxyl propyl methyl cellulose 15 CPS in a mixture of 45 g of dichloromethane and 20 g of isopropyl alcohol to get a composition having significantly reduced offensive odour. The solution containing oil phase is then sprayed on 150g of sugar spheres taken in a fluidbed coater with bottom spray mechanism, at 45 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with aqueous suspension of 0.5 kg of methacrylate copolymers and 0.05 kg vanilla flavour at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated beadlets at 45-48 deg C for 30 min. Example 7 50 g of oil containing omega-3 fatty acids( 60% DHA and 15% EPA is stirred vigorously with 75 g of 0.5 moles of phosphate buffer containing 15 microgram of Phospholipase A2( Sigma, St. Louis, Mo), 25 units of trypsin (Sigma, St. Louis, Mo) and 0.1% calcium chloride. The stirring is continued for 14 hrs at 36 degC. The oil phase is separated from the mixture and washed with water containing 0.2% sodium EDTA. The oil phase is then mixed with a solution containing 0.4 gm of mixed natural tocopherol, 35 g hydroxyl propyl cellulose in a mixture of 75 g of dichloromethane and 50 g of isopropyl alcohol to get a composition having significantly reduced offensive odour. The solution containing oil phase is then sprayed on 150g of sugar spheres taken in a fluidbed coater with bottom spray mechanism, at 45 deg C 1.5 kg air pressure. The oil coated sugar spheres are then coated with 20% aqueous suspension of 0.8 kg of polyvinyl alcohol at 45-48 deg C and 1.5-2 kg air pressure. The polymer coated beadlets are dried by fluidizing the coated beadlets at 45-48 deg C for 30 min. 200 gm of the dried beadlets are blended with 600 gm of granules comprising of microcrystalline cellulose, dicalcium phosphate and starch, and then compressed to form circular shaped tablets of 1 gm weight at lOkg/square cm pressure. Stability studies: The omeg-3 compositions of Example 1-7 were subjected to accelerated stability studies at 40 degree C. and 75% relative humidity. The beadlets/oil was analyzed for carotenoid content before and after 6 months. The result of the study is shown in the following Table 1. At the end of 6 months, the beadlets/oil was evaluated for EPA and DHA by Gas Chromatographic method and for fishy odour by a sensory panel. Tablets were compressed using these beadlets to verify level of fishy odour. Table 1: Results of accelerated stability study of beadlets at 40 deg C and 75% RH Product asperExampleNo. Initial DHA Content Initial EPA Content DHA content after 6 months EPA Content after 6 months 1 58.45% 14.67% 56.58% 14.44% 2 1.54% 12.46% 1.38% 12.22% 3 16.5% - 16.12% - 4 12.8% 2.76% 12.44% 2.54% 5 11.45% 2.65% 11.06% 2.46% 6 11.87% 2.96% 11.76% 2.77% 7 12.02% 2.56% 11.92% 2.43% Results of stability studies: At the end of 6 months of storage at 40 deg C and 75% RH, the drop in the content of EPA and DHA was found to be less than 10%. This ensures a minimum of two years of storage shelf life at ambient temperature. Sensory tests proved that there is nil to negligible odour offish or rancidity at the end of 6 months. Advantages of the invention 1. Provides a omega-3 fatty acid composition with significantly reduced offensive odour. 2. Provides a method of providing mega-3 fatty acid composition in the form of as powders, tablets or capsules which is stable. 3. Provides a convenient delivery form of omega-3 fatty acid in the form of free flowing beadlets. 4. Provides a form of omega-3 fatty acid composition in which the it is protected from harmful effects of oxygen, moisture and light and hence prevents rancidity and thereby generation of more fishy odour in the product. 5. Provides a form of omega-3 fatty acid composition which does not cause fishy burp after oral ingestion 6. Provides a omega-3 fatty acid composition which is free from impurities such as phospholipids, aliphatic amines and heavy metals thereby has significantly reduced offensive odour. We claim 1. A novel omega-3 fatty acid composition with significantly reduced offensive odour 2. A novel omega-3 fatty acid composition with significantly reduced offensive odour in the form of stable free flowing powders, beadlets, or tablets. 3. A process for the preparation of the novel omega-3 fatty acids composition which has significantly reduced offensive odour, which comprises (i) mixing thoroughly by heating at a temperature in the range of 35 to 38 Degree C for a period in the range of 10 to 20 hrs , an omega-3 fatty acid composition with a buffer containing phospholipase , trypsin and calcium chloride under continuous agitation, (ii) separating the resulting oil phase from the buffer, (iii) washing the oil phase with water containing sodium ethylene diamine tetraacetic acid (EDTA) under continuous agitation and , (iv) separating the oil phase from water phase to obtain omega-3 fatty acid composition having significantly reduced odour. 4 A process as claimed in claim 3 wherein the omega-3 fatty acid composition employed is derived from fish, algae or plant source. 5. A process as claimed in claims 3 & 4 wherein the composition comprises of 0-90% docosahexaenoic acid (DHA) and/or 0-90% eicosapentaenoic acid (EPA) 6. A process as claimed in claim 6 wherein the acids are in their esterified form. 7. A process as claimed in claim 3 to 6 wherein the buffer used (in step (i) is selected from the group of citrate, phosphate, borate type in the pH range of 3.5-8.5. 9. A process as claimed in claim 3 to 6 wherein the phospholipase used in step (i) is derived from animal or microbial origin. 10 A process as claimed in claim 3 to 6 wherein the phospholipase is selected from a group comprising phospholipase A, Al, A2, B, C and D.. 11. A process as claimed in claim 3 to 10 wherein the composition obtained in step (iv) is mixed with a solution of binder & stabilizer, and then made into stable beadlets by conventional methods 12. A process as claimed in claim 11 wherein the binder used is selected from the group comprising gelatin, starch, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone and the mixtures thereof. 13. A process as claimed in claims 11 & 12 wherein the stabilizer used is selected from the group comprising of ascorbic acid , mixed natural tocopherols, ascorbyl palmitate and mixtures thereof. 14 A process as claimed in claims 11 to 13 wherein the composition is treated with a protective antioxidants such as natural tocopherols, ascorbyl palmitate, tocopheryl acetate and mixtures thereof. 15. A process as claimed in claim 14 wherein the Tocopherol is selected from a group of alpha, beta, gamma and delta tocopherol or mixtures thereof . 16. A process as claimed in claims 12 to 15 wherein the beadlets are made by coating the composition on to sugar spheres in a fluid bed coater to form beadlets 17 A process as claimed in claims 12 to 16 wherein the beadlets obtained is coated with a protective polymer along with a odour masking agent and drying the coated omega-3 beadlets at a temperatures not exceeding 48 deg C to form coated beadlets, 18. A process as claimed in claim 17 wherein the polymer used for giving protective coating is be selected from a group comprising of methacrylate copolymers, hydroxypropyl methyl cellulose phthalate, shellac, shein, cellulose acetate phthalate. 19. A process as claimed in claims 12 to 18 wherein the beadlets obtained are coated with an odour masking agent 20. A process as claimed in claim 19 wherein the odour masking agent used is a flavour selected from vanilla, strawberry, mixed fruit, mango, orange, lemon and rose. 21. A novel omega-3 fatty acid composition which has significantly reduced offensive odour substantially as herein described with reference to the Example 1 22. A novel omega-3 fatty acids composition in the form of stable beadlets having significantly reduced offensive odour substantially as herein described with reference to the Examples 2 to 7 23. A process for the preparation of novel omega-3 fatty acid composition which has significantly reduced offensive odour substantially as herein described with reference to the Examples 1 to 7 ABSTRACT Novel omega-3 fatty acid composition with significantly reduced offensive odour and process for its preparation The invention disclosed in this application relates to novel omega-3 fatty acid composition with significantly reduced offensive odour . The process involves mixing thoroughly an omega-3 fatty acid composition with a buffer containing phospholipase , trypsin and calcium chloride under continuous agitation, separating the resulting oil phase from the buffer , washing the oil phase with water containing sodium ethylene diamine tetra acetic acid (EDTA) under continuous agitation and separating the oil phase from water phase . The invention also relates to a stable powders , tablets , beadlets forms of the above composition

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2418-MUM-2007-ABSTRACT(10-12-2007).pdf

2418-MUM-2007-ABSTRACT(2-6-2011).pdf

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2418-MUM-2007-ABSTRACT(GRANTED)-(28-2-2012).pdf

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2418-MUM-2007-CLAIMS(AMENDED)-(26-8-2011).pdf

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2418-mum-2007-claims.doc

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2418-MUM-2007-CLAMS(GRANTED)-(28-2-2012).pdf

2418-MUM-2007-CORRESPONDENCE(IPO)-(29-2-2012).pdf

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2418-mum-2007-description (complete).pdf

2418-MUM-2007-DESCRIPTION(COMPLETE)-(10-12-2007).pdf

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2418-MUM-2007-FORM 13(8-11-2011).pdf

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2418-MUM-2007-FORM 2(TITLE PAGE)-(10-12-2007).pdf

2418-MUM-2007-FORM 2(TITLE PAGE)-(2-6-2011).pdf

2418-MUM-2007-FORM 2(TITLE PAGE)-(26-8-2011).pdf

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2418-mum-2007-form 5(10-12-2007).pdf

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2418-MUM-2007-SPECIFICATION(AMENDED)-(2-6-2011).pdf

2418-MUM-2007-SPECIFICATION(AMENDED)-(26-8-2011).pdf

2418-MUM-2007-SPECIFICATION(AMENDED)-(8-11-2011).pdf