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Food high in Omega 3 does provide some very healthful benefits. Omega 3 Fatty Acids have been found to have benefits in a variety of

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

health conditions. Omega 6 Fatty Acids and Omega 3 Fatty Acids should be in balance at a ratio of approximately 3 Omega 6 to 1 Omega

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

3.

The diets of most Americans and Europeans are abundant in Omega 6 and at the same time are lacking in Omega 3’s. This imbalance h

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s been proven to be linked to such health conditions as Heart disease, Alzheimer’s, Diabetes, Arthritis and Macular Degeneration. By

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

increasing Omega 3’s (docosahexaenoic acid-DHA, eicosapentaenoic acid-EPA, and Alpha-linolenic acid-ALA) and decreasing Omega 6’s (Li

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

oleic acid and Arachodonic acid) this balance could be corrected.

With the corrected balance the conditions named above have been no

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ted to improve, to disappear and in some individuals prevented. It is recommended that children and adults who are ADHD/ADD have seen

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

a reduction in symptoms, increased attention spans, less difficulty learning and fewer problems with concentration and problematic b

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

havior. There are a wide variety of conditions that could be helped with the use Omega 3 supplements or eating food high in Omega 3.

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

There are four categories of food high in Omega 3. Aquatic sources include Wild Salmon, Tuna, Mackerel, Trout, Sardines, Anchovies a

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d Shrimp are excellent sources of Omega 3’s. Scallops Flounder, Oysters, King Crab, Whiting, and Halibut are also good sources. The b

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

est Aquatic source of Omega 3 is the Hoki fish native to the cold, fresh water of New Zealand.

Non-aquatic food high in Omega 3 incl

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ude Flax(flaxseeds, flaxseed oil, and ground flaxseed), Rapeseed Oil, Tofu (Soy protein), Spinach, boiled Broccoli and Cabbage, and d

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

rk green vegetables are high in Omega 3’s. Acai Palm Fruit, English Walnuts and Strawberries are all good sources of Omega 3. Meat so

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

urces high in Omega 3’s while currently limited include grass-fed cows and in the future will include other pastured animals.

Omega

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

’s is also added to foods as an additive which allows them to, in some cases be called health foods. More and more food manufacturers

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

are adding Omega 3 to foods. Walk through your local market and you will see Peanut Butter, Eggs, Baked goods including some breads

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

and cookies. Canned Tuna, Oysters, and Sardines are but a few of such foods with added Omega 3.

As always check with your physician

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

efore using Omega 3. While negative drug interactions rarely occur, you must be sure. Persons on medications and with medical conditi

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ons must be sure to consult the doctor for the appropriateness of using Omega 3 and the correct dosage that will benefit you the most

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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