E-Articles - Health and Fitness

The liver makes most of the cholesterol in the body, but dietary cholesterol plays an important role in controlling all the cholesterol levels in the body. The levels include the total cho

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

lesterol and the good and bad cholesterol. Good cholesterol, the HDL (high-density lipoproteins), protects the heart by helping to transport excess cholesterol from the arteries back to th

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

Examples of combination products may in

liver for breakdown and disposal. On the other hand, the bad LDL (low-density lipoproteins) cholesterol builds up plaque that clogs the arteries and hinders normal blood flow. A low chole

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

sterol diet should not only reduce the total cholesterol and LDL levels, it must also increase the HDL level at the same time.

Dietary Cholesterol

The main sources of dietary chol

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

sterol are animal-derived foods rich in cholesterol and saturated fats, such as organ meats, egg yolk, butter and other full-cream dairy products. Trans fats (as those in deep-fried foods)

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

Combination pro

and hydrogenated fats (as those in bakery items) are the other culprits. In a low cholesterol diet, you would replace saturated fats with polyunsaturated and monounsaturated fats such as

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

ils of olive, canola, peanut, flaxseed, sunflower, and so on.

Fats to Avoid

As far as trans fats and hydrogenated fats are concerned, it is advisable to avoid them as far as possi

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

ble, which means taking away French fries, crispies, cakes, cookies, pastries, and ice-creams from the low cholesterol diet menu.

Recommended Low Cholesterol Diet

Foods that shoul

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

make an essential part of a low cholesterol diet must come from the following food groups:

Cereals and grains: Whole-wheat bread, unpolished rice, and oats-based cereals are fo

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

ods that are rich in fiber, which helps sweep away the bad LDL cholesterol from the blood. In a low cholesterol diet it is essential to replace white bread and other refined, polished grai

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

s with whole-grain varieties.

Nuts and seeds: Nuts like almonds, peanuts, walnuts and seeds like flaxseeds are rich in antioxidants (such as vitamin E and selenium) and in good

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

Following aspects would a

fats, called omega-3 fatty acids, which protect the heart by increasing the HDL level. Nuts and seeds are also a rich source of fiber. The best way to include flaxseeds in a low cholestero

dd to the challenges in developing combination products:

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

l diet is by grinding them and sprinkling over cereals and salads.

Fish: Non vegetarians can choose to have a fatty cold-water fish such as salmon or tuna twice a week to get a r

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

ch supply of omega-3 fatty acids.

Beans and legumes: Beans, legumes and lentils are rich sources of protein and fiber and are low in fat content. They make an ideal substitute f

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

or meats. Soy cheese (tofu) is another good meat substitute in a low cholesterol diet.

Fiber-rich foods: Foods like oats, barley, psyllium, apples, pears, prunes, kidney beans an

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

Brussels sprouts are rich in soluble fiber, which acts like a broom to sweep out the cholesterol from the arteries.

Fruits and vegetables: Fresh fruits and vegetables are loade

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

Professional from academic institutions, pharmaceutical industries, health care indust

d with fiber, antioxidants, flavanoids and plant sterols, all of which help lower cholesterol and raise HDL level. Some 8–10 servings of fruits and vegetables should be included in the dai

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

y low cholesterol diet.

Garlic, onion: Some people believe garlic regulates liver functioning and dissolve the cholesterol deposits in the arteries. Others swear that including j

.

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

ust half a raw onion in the daily low cholesterol diet can lower LDL level and increase HDL level.

Following a low cholesterol diet, with regular exercise, and cutting out on

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

Companies that provide selfless information through particip

eats, full-cream dairy products, deep-fried foods and bakery items, can go a long way in lowering total cholesterol. Similarly, it lowers LDL cholesterol levels while raising the HDL level

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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