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Salt is essential to human life. But, like most good things, too much can be a killer. The National Heart, Lung and Blood Institute blame exce

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

ss sodium (salt) as a major reason for the high blood pressure that causes 400 daily American deaths from heart attacks and stroke. These deat

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

Examples of combination products may in

s are equivalent to a jet airliner crashing every single day.

The National Institutes of Health recommends less than 1.5 grams of sodium a da

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

. The average American gets about 4 grams and consuming up to 15 grams a day is not uncommon. Limiting daily sodium to less than 1.5 grams can

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

lower systolic blood pressure (the upper number) by as much as 5 to 10 points, which significantly reduces a person’s risk of heart attack and

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

Combination pro

stroke.

Sodium is found naturally in almost all foods. But added salt in processed foods is the major damaging food source of sodium. Excess

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

salt is found in bacon, hot dogs and processed meats, as well as frozen dinners, pizza, canned soups, etc.

The grams of salt in processed foo

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

s mounts up quickly. A cup of canned soup or a couple of slices of luncheon meat can each add another gram per serving to your daily limit. A

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

am and cheese sandwich with mustard adds over 2.5 grams and an order of chicken fajitas with tortillas, rice, beans and guacamole adds over 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

5 grams.

65 million Americans (beginning at age 6) have high blood pressure. Another 45 million have readings between120/80 and 139/90, which

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

is considered pre-hypertensive. According to recent research, about ninety percent of people in this “pre-hypertension” stage go on to develop

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

Following aspects would a

full blown high blood pressure during their lifetime.

You can lower blood pressure naturally without the use of medication. Begin by eliminat

dd to the challenges in developing combination products:

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

ng processed foods and refrain from adding extra salt at the table. Find low sodium substitutes. Read labels and avoid added MSG (monosodium g

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

luconate), sodium nitrate, nitrite, propionate, alginate, citrate, sulfite and even regular soy sauce. And be aware that baking soda, baking p

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

wder and many seasonings also contain sodium. You’re better off using natural salt free herbs and spices to season your food.

Eating a health

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

diet high in whole grains, fresh fruits and vegetables and low in saturated fat, trans fats and sodium can lower blood pressure by at least 1

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

Professional from academic institutions, pharmaceutical industries, health care indust

to 15 points. Losing weight helps too. One study showed that people who lost only eight pounds were half as likely to have high blood pressur

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

e symptoms. Research also shows that those who exercise regularly control their blood pressure just as well as those who exercise and take hyp

.

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

rtension medications.

Blood pressure is an important biomarker of health. Reducing your numbers by even just a few points can greatly decreas

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

Companies that provide selfless information through particip

your risk of both heart disease and stroke. So, put down that salt shaker and season your next meal with the salty wisdom of good whole foods

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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