The present invention is related to. stable multiiayered enteric coated dosage forms and process for preparation thereof.
BACKGROUND OF THE INVENTION
Encapsulation of pharmaceutical agents is one of the most popular methods for administering drugs. Capsules are solid dosage forms in which the drug substance is enclosed in either a hard or soft, soluble container or shell of gelatin or other suitable material. Advantages of capsules over other solid dosage forms includes better patient compliance, greater flexibility in dosage form design and less expensive manufacturing processes. Pharmaceutical capsules are conventionally divided into soft shell capsules and hard shell capsules. The characteristics of soft shell and hard shell capsules are described in, Remington:Essentials of Pharmaceuticals, 1st ed., Pharmaceutical Press, London (2013).
Site specific drug delivery that circumvents the stomach is effective therapy for colon-related diseases such as irritable bowel syndrome or in cases when the active ingredient is irritating to the gastric mucosa or in case of acid labile drug molecules which are degraded by digestive enzymes present in stomach. Site Specific delivery has also been demonstrated to improve the absorbance of poorly water soluble drug. Specific colonic drug delivery depend on the variation in pH values through the

gastrointestinal tract. Site specific drug delivery in the colon can be achieved by means of enteric coating, which is insoluble in the acidic conditions in the stomach but dissolves at neutral pH.
The effects of long chain polyunsaturated fatty acids from fish oils on cardiovascular disease are quite well established. In a clinical trial which included 942 Japanese hyperchoiesterolemic patients with stroke, use of EPA led to significant reduction of stroke recurrence. [Tanaka, et.al. (2008) Reduction in the recurrence of stroke by eicosapentaenoic acid for hyperchoiesterolemic.patients: Subanalysis of the JELIS trial. Stroke 39(7):2052-2058]. Further in a trial including 51 epilepsy patients, seizure frequency was reduced over the first six weeks of supplementation with long chain polyunsaturated fatty acids [Yuen, et al., (2005) Omega-3 fatty acid supplementation in patients with chronic epilepsy: A randomized trial. Epilepsy and Behavior 7(2):253-258)] Use of Polyunsaturated fatty acids was also associated with a lower risk of mortality in stroke patients [Garbagnati, F, (2009) Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. Cerebrovascular Diseases 27(4):375-383)].
One of the primary reasons of discontinuation of polyunsaturated fatty acid, which is an excellent source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is the fishy burps which occur when the fish oil interacts with the acid bf the

stomach. Several prior art describing the usage of enteric coating which allows the delivery of the active ingredient directly into the small intestine are present.
US20100239660 describes the use of soft gel capsule filled with microalgae oil. Omega-3 fatty acids soft gel capsule are taught in CN103908441 which are enteric coated. WO2011048493 discloses a coated gelatin capsule comprising fatty acid oil mixture comprising EPA and DHA.
Another major challenge of aqueous enteric coating on soft capsules is its dissolution. The enteric coating interacts with the material of the soft capsules resulting in a faulty dissolution profile. A faulty dissolution profile as a result of interaction between capsule layer and enteric layer may result in faulty release profile. The early release of the fish oil in the stomach will result in fishy burps inspite of use of enteric coated capsule.WO 2016/056229 provides a method of producing seamless soft capsules that have an enteric coating and exhibit superior production characteristics. Enteric coated seamless soft capsules are produced by preparing an enteric capsule coating solution which has a viscosity of 60 127 mPa-s at 50°C and encapsulating the capsule contents by means of a falling drop technique using the prepared enteric capsule coating solution.
Indian Patent Application 222/CHE/2015 describes granulates of Dimethyl fumarate comprising of gastro resistant or enteric, polymers and other excipients. The

invention discloses novel oral dosage forms of Dimethyl fumarate comprising an admixture of Dimethyl fumarate and excipients filled in an enteric coated capsule. WO/2011/012369 discloses coating compositions for the enteric coating of capsule halves made of water-soluble or water-swellable polymer material in the dipping process. US5330759 discloses Soft, capsules coated with an enteric coating comprising a 1:1 copolymer of methacrylic acid and methyl or ethyl acrylate or methyl or ethyl methacrylate and a plasticizer without need for a subcoating and optionally additionally coated with a protective coating comprising hydroxypropyl methylceliuiose or hydroxypropyl cellulose or a mixture thereof and a plasticizer and method of preparation. US20150342892 relates to a novel aqueous coating composition comprising a polymer, at least one glidant, and at least one emulsifier, and at least one plasticizer, for soft capsule shells or soft gel capsules, providing an enteric release profile, and to a method of enteric coating of soft capsule shells or containers; and to the resulting enteric coated soft capsule shells or soft gel capsules with the aqueous coating composition.
Although their are prior art teaching the use of polyunsaturated fatty acid in enteric coated capsule but none of them tackle the issue of the interaction between the capsule layer and the the enteric coat and the effect of the same. Thus their is still need of oral solid dosage in capsule forms which provides a uniform release profile

and prevents interaction between the components of the capsule. The present invention provides a. multilayered capsule consisting of seal coating between the capsule layer and the enteric coating which provides uniform release profile and also overcomes the problem of fishy burps.
OBJECTIVE OF THE INVENTION
The objective of the present invention is to provide a multilayered capsule consisting of seal coating between the capsule layer and the enteric coating layer. The seal coating act as a barrier layer which prevent interaction between the capsule layer and the enteric layer which results in a suitable uniform release profile. Thus another objective of the present invention is to provide a multilayerd capsule consisting of a seal coating which act as a barrier layer, between the capsule layer and the enteric coating layer, thereby resulting in an enteric coated capsule with uniform release profile.
An objective of the present invention is to provide multilayered enteric coated soft or hard shell capsule wherein the capsule layer is made from vegetable so.urces. Another objective of the present invention is to provide a multilayered enteric coated capsule for site specific delivery of polyunsaturated fatty acids. An objective of the present invention is to provide a pharmaceutical or nutraceutical formulation of enteric coated capsules with uniform release profile and lesser side effects.

Yet another objective of the present invention is provide a pharmaceutical or nutraceutica! formulation of enteric coated capsule for the treatment, modulation or prophalaxis of coronary disease, altering serum LDL-cholesterol and/or HDL-cholesterol, lowering serum triglycerides, lowering blood pressure, pulse rate, altering the activity of the blood coagulation factor VII complex, mild hypertension, protection from cyclosporine toxicity in kidney transplant, rheumatoid arthritis, development and progression of retinopathy, hypertriglyceridemia, and neurological disorders in a subject.
SUMMARY OF THE INVENTION
The present invention discloses a pharmaceutical or nutraceutical composition in unit dosage form comprising a hard or soft shell capsule consisting of one or more active ingredients and pharmaceutical^ acceptable excipients, a seal coating on the hard or soft shell capsule layer and an enteric coating on the sealcoated hard or soft shell capsule layer.
DETAILED DESCRIPTION OF THE INVENTION
The present invention discloses enteric-coated hard or soft shell capsules and the process of coating thereof. Further, the present invention describes the multilayered coating system and the advantages related to the same. According to the present invention, the hard or soft shell capsules were initially coated with a seal coating and

then they are subjected to enteric coating so as to provide a stable product with suitable release profile.
Capsules can be either hard or soft shelled. A hard capsule consists of two section one sliping over the other whereas soft capsule walls are typically thicker than two-piece hard gelatin capsules, and their walls comprise plasticizers such as, for example, glycerol, sorbitol and/or propylene glycol to make the shell elastic. In an embodiment the invention provides a enteric coated hard or soft shell capsule, wherein a seal coating acting as a barrier between the hard or soft shell capsule . layer is provided. In a preferred embodiment the invention provides a enteric coated soft shell capsule wherein a seai coating acting as a a barrier between the hard or soft gel capsule is provided.
In an embodiment of the invention a multilayerd hard or soft shell capsule comprising a seal coating between the capsule layer and the enteric coating layer is provided. The sea! coating act as a barrier layer which prevents the interaction between the capsule layer and the enteric coating layer thereby providing a enteric coated hard or soft shell capsule with uniform release profile. Thus in a preferred embodiment of the invention a multilayered hard or soft shell capsule wherein a seal coating acting as a barrier between the capsule layer and the enteric coating layer is provided.

In another embodiment a pharmaceutical or nutraceutical formulation is provided " wherein the formulation consists of hard or soft shell capsule. In a preferred embodiment the hard or soft shell capsule is seal coated. In a most preferred embodiment the invention provides a pharmaceutical or nutraceutical formulation wherein the formulation consist of an seal coated hard or soft shell capsule, wherein an enteric coating has been added over the seal coating. In a further preferred embodiment the seal coating acting as a barrier layer between the capsule layer and the enteric coating layer. The said seal coating acting as the barrier layer prevents interaction between the ingredients of the capsule layer and the enteric coating thereby providing a capsule with uniform release profile. Thus in a most preferred embodiment the invention provides a multilayered enteric coated hard or soft shell capsule with uniform release profile.
One of the primary disadvantages of polyunsaturated fatty acids, which is an excellent source of EPA and DHA, is the fishy burps which occur when the fish oil interacts with the acid of the stomach. Even with enteric coating the problem exist due to faulty dissolution profile caused by the interaction between the capsule layer and enteric coating layer. In an embodiment the invention provides a pharmaceutical or nutraceutical formulation containing polyunsaturated fatty acids devoid of unwanted side effects like fishy burfs. In a preferred embodiment the present invention provides a pharmaceutical or nutraceutical formulation

comprising a multilayered enteric coated capsule for the site specific delivery of polyunsaturated fatty acids devoid of side effects. In a most preferred embodiment the present invention provides a pharmaceutical or nutraceutical formulation comprising a multilayered enteric coated capsule for the site specific delivery of polyunsaturated fatty acids, wherein a seal coating act as the barrier layer between the. capsule layer encapsulating the polyunsaturated fatty acid and the enteric coating layer.
In a preferred embodiment the present invention provides a pharmaceutical or nutraceutical composition in unit dosage form comprising a hard or soft shell capsule consisting of one or more active ingredients and pharmaceutical^ acceptable excipients, a seal coating on the hard or soft shell capsule layer and an enteric coating on the seal coated hard or soft shell capsule layer. In a most preferred, embodiment the invention provides a pharmaceutical or nutraceutical composition in unit dosage form comprising a hard or soft shell capsule consisting of polyunsaturated fatty acids and pharmaceutically acceptable excipients, a seal coating on the hard or soft shell capsule layer and an enteric coating on the seal coated hard or soft shell capsule layer.The active agent are selected from polyunsaturated fatty acid. Preferably the active agent are selected from any desirable and appropriate source, such as Krii oil, cod liver oil, Salmon Fish Oil and any other fish oil with any combination of EPA and DHA, Omega 3 marine glycerides

with any combination of EPA and DHA. In preferred embodiment the active agent is present in the range of 1% to 99%, preferably in the range of 20% to 90%, most preferrably. 50% to 90% and in the most preferred embodiment in the range of 66.0% to 73.0 % by weight of the formulation
In another preferred embodiment the active ingredient are present in the range of 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%,63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 78%, 79%, 80% by weight. In a most preferred embodiment the active ingredient is present in the range 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73% by weight.
In another embodiment the active ingredient is present in the range of 500 mg, 510 mg, 520 mg, 530 mg, 540 mg, 550 mg, 560 mg, 570 mg, 580 mg, 590mg, 510 mg by weight of the capsule. In a most preferred embodiment the active ingredient is present in the range of 550mg by weight of the capsule.
In an embodiment of the invention the hard or soft shell capsule layer consist of gelling agents, plasticizer, preservative, stiffening agqnts, solvents or a combination thereof. The gelling agents are selected from group of gelatin, pectin, casein, collagen, protein, modified starch, polyvinyl pyrrolidone. In a preferred embodiment the gelling agent is gelatin. In a preferred embodiment the gelling agent is present in

the range of 1 to 60%, preferably in the range of 10% to 60% by weight of the capsule, preferably in the range of 10% to 20% by weight of the capsule.
In a preferred embodiment the gelling agents are present in the range of 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19% by weight of the capsule. In a most preferred embodiment the gelling agent is present in the range of 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18% by weight of the capsule.
In another embodiment of the invention the gelling agent is present in the amount of 100 mg to 200 mg. In a preferred embodiment the gelling agent is present in amount of 110 mg to 140 mg. In a most preferred embodiment the gelling agent is present in the amount of of 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg.
The seal coating in the multilayered enteric coated capsule of the present invention comprises a Coating agent, Plasticizer and Solvent. The coating agent is selected from the group of Hydroxypropyl methyl cellulose, Ethyl cellulose, Polyvinyl alcohol, starch, cellulose acetate or combination thereof. Preferably the coating agent is Hydroxypropyl methyl cellulose. The coating agent is present in the range of 0.1% to 10%, preferably in the range of 0.5% to 5% and most preferably in the range of 0.8% to 2% by weight of the caosule. In a most preferred embodiment the coating agent is present in the range of 1% to 2% by weight of the capsule. In a further preferred

embodiment the coating agent is present in the range of 1.1%, 1.2%, 1.3%, 1.4%, 1.6%, 1.7%, 1.8%, 1.9%, 2% by weight of the capsule.
In another embodiment the seal coating is present in the range of 5 mg to 40 mg. Preferably in the range of lOmg to 20mg and most preferably in the amounts of llmg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg. .
The enteric coating layer in the multilayered enteric coated capsule of the present invention comprises a Enteric coating agent, Plasticizer and Solvents. The enteric coating agent is selected from Ethylcellulose, Cellulose acetate phtalate, polyvinyl acetate, Hydroxyropyl methulcellulose phthalate, Methacrylic acid copolymer or a combination thereof. Preferably the enteric coating agent is Ethylcellulose or Methaacryiic acid copolymer or both. In a most preferred embodiment the enteric coating layer comprises of two coating agent.. In an embodiment the enteric coating agent is present in the range of l%.to 99% by weight of the capsule. !n a preferred embodiment the enteric coating agents are present in the range oil % to 10% by weight of the capsule. In a most preferred embodiment the enteric coating agent are present in the range of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10% by weight of the capsule.
In another embodiment of the invention wherein the enteric coating layer comprises of two coating agents in the weight ratio of 70:30 to 90:10. In a preferred

embodiment the ratio of the coating agent is 80:20, 81:19, 82:18, 83:17, 84:16, 85:15, 86:14, 87:13, 88:12, 89: 11, 90:10. In a most preferred embodiment the ratio of the coating agents is 85:15.
The plasticizer present in the composition are selected from Hydroxy propyl Cellulose, Polyethylene glycol, Triethyl citrate, triacetin. DBS, castor oil or combination thereof. In a preferred embodiment the plasticizer are Glycerin or Polyethylene glycol or a combination thereof. The plasticizer are present in the range of 1% to 50%, preferably in the range of 1% to 30% and most preferably in the range of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20% by weight of the capsule.
In another embodiment the plasticizer are present in the amount of 5 mg to 50 mg. Preferably in the amount of 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg. Most preferably in the amount of 5 mg, 5.50 mg, 8 mg, 8.67 mg, 9 mg.
The preservative are selected from Sodium benzoate, Benzoic acid, Potassium sorbate, Sorbic acid, sodium methyl paraben, sodium propyl parabens and combination thereof. In an preferred embodiment the Preservative are selected from Methyl paraben or Propyl paraben or both. The preservative are present in the range of 0.01 % to 0.99%, preferably in the range of 0.01% to 0.08% and most

preferably in the range of 0.02%, 0.03%, 0.04%, 0.05%, 0.06% by weight of the capsule.
In another embodiment the preservative are present in the amount of O.lmg to 2 mg. In a preferred embodiment the preservative are present in the amount of 0.3 mg to 0.7 mg. In a most preferred embodiment the preservative are present in 0.27 mg and 0.54 mg.
In an preferred embodiment the pharmaceutically acceptable solvents is selected from but not limited to purified water, Isopropyl Alcohol, Mehylene dichloride or combination thereof. In an preferred embodiment the stiffening agent is selected from but not limted to Propylene glycol, sorbitol, polyvinyl alcohol or a combination thereof.
In an embodiment the present invention provides a pharmaceutical composition wherein, the average weight of the empty hard or soft gelatin, capsule is 150 mg to 250mg, preferably in the range of 200mg to 220mg. Empty Hard or Soft shell Capsule means a capsule comprising pharmaceutically acceptable shelling agent, platicizer, preservative, stiffening agent and solvent/ and without the active ingredient fill or any kind of coating.
In another embodiment the total weight of the filled Hard,or Soft gelatin capsule is 650mg to 850 mg, preferably in the range of 740mg to 780mg. Filled hard or soft

shell Capsule means an Empty Soft Shell Capsule wherein the active ingredient fill is present but without any kind of coating.
In another embodiment the average weight of the seal coated hard or soft shell capsule is in the range of 700 mg to 800mg. Seal Coated hard or soft shell capsule as means an Soft shell capsule wherein a seal coating has been added but without any Enteric coating. In another embodiment the average weight of the enteric coated hard or soft shell capsule is in the range of 750mg to 900mg, preferably in the range of 800mg to 900mg. Enteric Coated hard or soft shell capsule means a Seal Coated hard or Soft shell Capsule wherein an Enteric coating has been added
In an embodiment the invention provides a method of treatment, modulation or prophalaxis of coronary disease, altering serum LDL-cholesterol and/or HDL-cholesterol, lowering serum triglycerides, lowering blood pressure, pulse rate, altering the activity of the blood coagulation factor VII complex, mild hypertension, protection from cyclosporine toxicity in kidney transplant, rheumatoid arthritis, development and progression of retinopathy, hypertriglyceridemia, and neurological disorders in a subject.
In another embodiment of the present invention a pharmaceutical or nutraceutical composition is provided wherein the enteric coating is directly applied to the hard or soft shell capsule layer.

Processes for making hard or soft shell capsules are known in art. The hard or soft gel capsule can be prepared by conventional methods known in the art. In a further embodiment of the invention the process for preparation of the multilayered enteric coated hard or soft shell capsule is provided. The process for preparation comprises of following steps
Gelatin Mass Preparation:
a) Take Glycerin in a heat jacketed vessel and heat up to 60-70°C and add methyl paraben and propyl paraben, Stir to get clear solution.
b) Now add required amount of Sorbitol (70% Non- Crystalline), Purified water and P.E.G.400, Stir to get uniform solution.
c) Now add gelatin granules with heating and stirring to get a clear semisolid gel like mass with naturalcolor.
d) Provide the sufficient amount of vacum to avoid air entrapment in the gelatin mass.
Encapsulation:
a) Fill the required amount of medicament in gelatin mass. Dry in required humidity and temperature.
Coating: (Seal Coating}

a) Prepare coating system of Hydroxypropyl methylcellulose (HPMC -E5) with plasticizer PEG-6000.
b) Take required quantity of Isopropyl alcohol in a suitable container and add accurate quantity, of HPMC - E5 into it and stir well.
c) Take another container with required qty of Methylene Dichloride and add accurate qty. of PEG-6000 into it and stir well until get dissolved.
d) Add step-3 into step-2 with continuous stirring with the help of mechanical stirrer.
e) Filter this solution through 200mesh nylon cloth.
f) Film coating was done with above prepared solution in auto coater.
Coating: (Enteric Coating)
a) Prepare Enteric coating system of Hydroxypropyl NS enteric, Surelease plasticizer Triethyl citrate.
b) Take required qty. of Purified water in SS container. Now add accurate qty. of NS enteric into it with continuous stirring with the help of mechanical stirrer until it dissolved.
c) Now add Surelease and Triethyl citrate into it and mix it for next 2 hours with mechanical stirrer.
d) Enteric coating was done in auto coater.

The following examples are intended to illustrate the present disclosure without, however, being limiting in nature. It is understood that the skilled artisan will envision additional embodiment consistent with the disclosure provided herein.
EXAMPLES
Example 1: Multilayered enteric coated hard or soft shell capsule with seal coating and enteric coating

S. No. Material Name Label Claim (mg/capsule)
GELATIN MASS PREPERATION:
1. Gelatin (Soft shell 4 Mesh) 150-180 Bloom 126. mg
2. Glycerin 42 mg
3. Methyl Paraben 0.546mg
4. Propyl paraben 0.27 mg
5. P.E.G. 400 8.67 mg
6. Sorbitol {70% Non- Crystalline) 29.19 mg
7. Purified Water 3.324 mg
Average weight of Empty Soft Gel capsule = 210 mg
MEDICAMENT PART:
8. OMEGA 3 MARINE TRIGLYCERIDE (33:22) 550 mg
Average Fill Weight of Soft gel Capsule = 550 mg Total weight of filled soft gel capsule = 760 mg
COATING:
9. HPMC-E5 14.50 mg
10. PEG-6000 5.50 mg
11. IPA (40%) 16 ml*
12. MDC(60%) 24 ml*
Average weight of seal coated Soft gel Ca osule= 779mg
13. Surelease 76.50 mg
14. NS enteric 13.50 mg
15. Triethyl citrate 2.70 mg
16. Purified Water -
Average weight of Enteric coated Soft gel Capsule= 857 mg

Example 2: Multilayered enteric coated hard or soft shell capsule with only enteric
coating

S. No. Material Name mg/capsule
GELATIN MASS PREPERATION:
1. Gelatin (Soft shell 4 Mesh) 150-180 Bloom 126 mg
2. Glycerin 42 mg
3. Methyl Paraben 0.546mg
4. Propyl paraben 0.27 mg
5. P.E.G.400 8.67 mg
6. Sorbitol (70% IMon-Crystalline) 29.19 mg
7. Purified Water 3.324 mg
Average weight of Empty Soft Gel capsule = 210 mg
MEDICAMENT PART:
8. OMEGA 3 MARINE TRIGLYCERIDE (33:22) 550 mg
Average Fill Weight of Soft gel Capsule = 550 mg Total weight of filled soft gel capsule = 760 mg
9 Surelease 74.48 mg
10. NS enteric 12.92 mg
11. Triethyl citrate 2.58 mg
12. Purified Water -
Average weight of Enteric coated Soft gel Capsule= 836mg
Example 3: Multilayered enteric coated hard or soft shell capsule with only enteric coating

S. No. Material Name mg/capsule
GELATI M MASS PREPERATION:
1. Gelatin (Soft shell 4 Mesh) 150-180 Bloom 126 mg
2. Glycerin 42 mg
3. Methyl Paraben 0.546mg
4. Propyl paraben 0.27 mg

5. P.E.G.400 8.67 mg
6. Sorbitol (70% Non- Crystalline) 29.19 mg
7. Purified Water 3.324 mg
Average weight of Empty Soft Gel capsule = 210 mg
MEDICAMENT PART:
8. OMEGA 3 MARINE TRIGLYCERIDE (33:22) 550 mg
Average Fill Weight of Soft gel Capsule = 550 mg Total weight of filled soft gel capsule = 760 mg
9. Acrylcot ERD 4.56 mg
10. Triethyl citrate 0.022 mg
11. Purified Water -;"
Average weight of Enteric coated Soft gel Capsule^ 836mg

We Claim,

1.A pharmaceutical or nutraceutical composition in unit dose form comprising:
(a) a hard or soft capsule containing a fill consisting of one or more active ingredients and wherein the fill further contains pharmaceutical^ acceptable excipients; and
(b) a seal coatings on the hard or soft capsule of (a)
(c) an enteric coating on the seal coated hard or soft capsule of (b)

2. The pharmaceutical or nutraceutical composition according to claim 1 wherein the seal coating acts as a barrier coating between the capsule layer and the enteric coating layer.
3. The pharmaceutical or nutraceutical composition according to claim 1 wherein the active ingredients is selected from fish oil with any combination of EPA and DHA.
4. The pharmaceutical or nutraceutical composition according to claim 1, wherein the said capsule is selected from the group consisting of gelatin, pectin, casein, collagen, protein, modified starch, polyvinyl pyrrolidone.
5. The pharmaceutical or nutraceutical composition according to claim 1, wherein the Seal Coating comprises of Coating agent, Plasticizer and pharamceutically acceptable solvent.
6. The coating agent according to claim 5 is selected from Hydroxypropyl methyl
cellulose, Ethyl cellulose, Polyvinyl alcohol, starch, cellulose acetate or combination
thereof
7. The plasticizer according to claim 5 is selected from Hydroxy propyl Cellulose, ;
Polyethylene glycol, Triethyl citrate, triacetin DBS, castor oil or combination thereof.

8. The enteric coating according to claim 1 comprises of atieast one or more pharmaceutical^ acceptable enteric coating agent, plasticizer and pharmaceutically acceptable solvent.
9. The enteric coating agent according to claim 8 is selected from group of Cellulose acetate phthalate, polyvinyl acetate,, Hydroxypropyl methyl cellulose phthalate, Ethylcellulose, Methaacryiic acid copolymer or a combination thereof

10. The plasticizer according to claim 1 is selected from group of Tributyl citrate, triacetin, castor oil, triethyl citrate or a combination thereof
11. The pharmaceutical or nutraceutical composition according to claim 1, wherein the dosage form is suitable for oral administration.
12. A pharmaceutical or nutraceutical composition in unit dose form comprising:

(a) a hard or soft capsule containing a fill consisting of one or more active ingredients and wherein the fill further contains pharmaceutically acceptable excipients; and
(b) an enteric coating on hard or soft capsule of (a)
13. The pharmaceutical or nutraceutical composition according to claim 1, for
treatment, modulation or prophalaxis of coronary disease> altering serum
LDL-cholesterol and/or HDL-cholesterol, lowering serum triglycerides, lowering
blood pressure, pulse rate, altering the activity of the blood coagulation factor VII
complex, mild hypertension, protection from cyclosporine toxicity in kidney
transplant, rheumatoid arthritis, development and progression of retinopathy,
hypertriglyceridemia, and neurological disorders in a subject.