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Sodium bicarbonate, commonly known as baking soda, is used as a medication to neutrali

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

ze stomach acid in ulcer patients and as a home remedy for stomach distress. Now resea

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

Examples of combination products may in

chers in Greece have shown that it may neutralize the acid in muscles during intense e

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

ercise and helps athletes to exercise longer (Medicine & Science in Sports & Exerc

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

se, October 2006).

If you run or cycle as hard as you can, you start to breathe

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

Combination pro

ard, and suddenly your leg muscles start to burn because your muscles have become acid

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

c. It’s the burning in your muscles that forces you to slow down. Muscles get the ener

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

y to move your body from the food that you eat. Carbohydrates are broken down step by

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

tep in a chain of reactions to release energy for your muscles. Each step requires oxy

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

en. If you have enough oxygen, the carbohydrates are eventually broken down to carbon

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

ioxide and water that you can blow off from your lungs. However, if you can’t get all

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

Following aspects would a

the oxygen that you need, the series of reactions stops and lactic acid accumulates in

dd to the challenges in developing combination products:

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

your muscles and spills over into your bloodstream. The acidity in muscles caused by t

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

e accumulation of lactic acid is what makes your muscles burn.

When acid is exposed t

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

an alkaline or base, it combines with it to neutralize the acid and form water. What

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

ould happen when an athlete takes the base, sodium bicarbonate, before he competes? He

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

Professional from academic institutions, pharmaceutical industries, health care indust

would be able to exercise longer if the bicarbonate got into the muscle and neutralize

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

the burning caused by the acid. The authors of this study showed that higher doses of

.

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

sodium bicarbonate were more effective in preventing burning. This exercise aid is sti

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

Companies that provide selfless information through particip

l experimental, so we will have to wait for further research to see if it really works

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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