E-Articles - Health and Fitness

The body needs cholesterol for digesting dietary fats, making hormones, building cell walls, and other importan

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

t processes. The bloodstream carries cholesterol in particles called lipoproteins that are like blood-borne car

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

Examples of combination products may in

o trucks delivering cholesterol to various body tissues to be used, stored or excreted. But too much of this ci

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

rculating cholesterol can injure arteries, especially the coronary ones that supply the heart. This leads to ac

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

umulation of cholesterol-laden "plaque" in vessel linings, a condition called atherosclerosis.

When blood flow

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

Combination pro

to the heart is impeded, the heart muscle becomes starved for oxygen, causing chest pain (angina). If a blood c

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

lot completely obstructs a coronary artery affected by atherosclerosis, a heart attack (myocardial infarction)

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

r death can occur.

Heart disease is the number one killer of both men and women in the United States. More tha

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

n 90 million American adults, or about 50 percent, have elevated blood cholesterol levels, one of the key risk

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

actors for heart disease, according to the National Heart, Lung, and Blood Institute's National Cholesterol Edu

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

ation Program.

Cholesterol lowering supplements containing Policosanol or Red Yeast Rice are known to assist i

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

Following aspects would a

n lowering cholesterol levels.

Policosanol
Policosanol is a natural supplement derived from sugar cane. I

dd to the challenges in developing combination products:

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

is a mixture of eight higher primary aliphatic alcohols isolated and purified from sugar cane wax. One of the

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

newest and more successful substances that benefits those suffering from high cholesterol is Policosanol, which

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

is a safe and natural extract from sugar cane wax. It works by helping the liver control production and breakdo

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

n of cholesterol. Policosanol promotes healthy platelet function and helps to maintain cholesterol levels that

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

Professional from academic institutions, pharmaceutical industries, health care indust

are already within the normal range.

Red Yeast Rice
Red Yeast Rice is the product of yeast ( Monascus pur

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

ureus ) grown on rice, and is served as a dietary staple in some Asian countries. It contains several compounds

.

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

collectively known as Monacolins, substances known to inhibit cholesterol synthesis. Red Yeast Rice is propose

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

Companies that provide selfless information through particip

to be a mild aid for gastric problems (indigestion, diarrhea), blood circulation and spleen and stomach health

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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