Advice Pool - Health and Fitness

Medical research has shown that Crohn’s disease sufferers can greatly improve their overall health by including more omega-3 fatty acids in their diet. Omega-3 fatty a

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

cids are essential nutrients the body requires but cannot produce itself. They are found in fish and certain plant oils. Studies have shown that omega-3 fatty acids,

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

Examples of combination products may in

articularly those found in fish oil, have anti-inflammatory properties that can have a therapeutic effect on Crohn’s disease.

There are three major types of omega-3 fa

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

ty acids:

1. Eicosapentaenoic (EPA)

2. Docosahexaenoic acid (DHA)

3. Alpha-linolenic acid (ALA)

When eaten, ALA is converted into EPA and DHA, the two fatty acids t

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

at are primarily used by the body for different process such as improving cardiovascular function, lowering blood pressure and brain function. Moreover, as was previou

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

Combination pro

ly mentioned, the EPA and DHA have anti-inflammatory properties.

When it comes to treating Crohn’s disease with omega-3 fatty acids, fish oil supplements have been use

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

d as an alternative or complimentary treatment in a number of medical studies over the course of several years. The results of these studies have varied.

For instance,

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

some researchers have discovered that while fish oil may help reduce preexisting inflammation, it does not actually help prevent inflammation from occurring. Furthermo

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

e, omega-3 fatty acids only appear to be a beneficial treatment for those who suffer from mild to moderate cases of Crohn’s disease.

In addition, studies have found th

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

t due to the positive influence fish oil has on intestinal cell growth, fish oil supplements may eventually increase the intestinal mucosal surface area. This would re

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

ult in the increase of nutrient absorption, and improve a person’s overall nutrition.

The studies that have been conducted on the anti-inflammatory effect of fish oil

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

Following aspects would a

show a promising future. More research must be done before it can be determined just how effective fish oil is in treating chronic inflammatory conditions such as Croh

dd to the challenges in developing combination products:

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

’s disease. Before you talk to your doctor about taking fish oil supplements, you should first try the natural method of ingesting food rich in omega-3 fatty acids. G

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

od sources included the following:

• EPA and DHA - Cold water fish (IE halibut, herring, mackerel, salmon and sardines)

• ALA – canola oil, flaxseeds and oil, pumpkin

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

seeds and oil, perilla seed oil, purslane, walnuts and oil.

• Enriched foods – It’s also not a bad idea to eat foods that have had omega-3 included in their ingredient

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

such as omega-3 margarine and omega-3 eggs.

In order to ensure you are receiving the recommended amount of omega-3 in your diet to help treat your Crohn’s condition,

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

Professional from academic institutions, pharmaceutical industries, health care indust

you should eat two-three servings of fish each week (approximately 1,250 mg of EPA and DHA a day). If you find it difficult to eat this amount of fish in a week, talk

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

o your doctor about taking fish oil supplements.

Finally, although omega-3 fatty acids can help improve many of the symptoms in Crohn’s disease sufferers, remember tha

.

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

medical research is still being conducted to find out how beneficial fish oil supplements are for inflammatory bowel disease. While it has shown many positive side ef

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

Companies that provide selfless information through particip

ects, some patients in studies concerning the anti-inflammatory affects of fish oils encountered symptoms of halitosis (bad breath), belching, diarrhea and constipation

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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