Advice Pool - Health and Fitness

One diabetic side effect is neuropathy. This is a condition where the nerves of the body are damaged. It is called “Diabetic Peripheral (referring

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

to the outer part of the body) Neuropathy”. This type of neuropathy affects the feet and legs, hands and arms, and it can occur on both sides of 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

body. In fact, 40 percent of type 2 diabetics experience Diabetic Peripheral Neuropathy.

Diabetic Peripheral Neuropathy shows up as one or more o

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 following symptoms:|

* Tingling or numbness in the fingers, toes or legs.
* Feeling cold, burning or pain in the hands, feet or legs

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

* Extreme sensitivity to touch, even a light touch.
* Sharp pains or cramps.
* Loss of balance and coordination.

These symptoms ar

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

Combination pro

often worse at night.

Higher than normal sugar levels in the body cause the outer sheathing (protective covering) of nerve cells to degenerate. T

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

is is similar to an electrical wire that is covered with insulation, and the insulation is beginning to crumble. Without insulation the unprotected

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

wire will start short-circuiting.

In the same way, when the sheathing of nerve cells degenerate, the signals being transmitted are scrambled, res

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

lting in your body receiving signals that are interpreted as numbness, heat, cold, tingling, pain, etc.

It has been known for some time that incre

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

sed levels of Tiamine (vitamin B1) in the blood stream are very effective in reducing and reversing diabetic neuropathy. Unfortunately, the oral in

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

ake of vitamin B1 does not greatly increase the levels of B1 in the blood stream. Previously, the way that blood stream levels of B1 were increased

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

Following aspects would a

was through periodic intravenous feeding or through injections every few weeks.

The reason that methods like this had to be used is that Tiamine (

dd to the challenges in developing combination products:

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

ometimes spelled Thiamine), like all of the B vitamins, is water-soluble. It cannot be stored in the body and flushes out within 4 to 5 hours. Oral

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

intake of Tiamine over 5 mg results in greatly reduced bioavailability and immediate flushing from the body (this is why urine frequently turns yel

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

low when taking larger doses of B vitamins).

Now, a new type of vitamin B1 has been produced, called Benfotiamine. It is a fat-soluble version of

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

itamin B1. What this means is that this new form of vitamin B1 can be taken orally in large dosages and it will not flush out of the body the way o

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

Professional from academic institutions, pharmaceutical industries, health care indust

dinary Tiamine (vitamin B1) does.

The result is that the blood stream levels of vitamin B1 can now be greatly increased, enabling a rapid and effe

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

tive decrease or elimination of the symptoms of Diabetic Peripheral Neuropathy.

Many of our diabetics now using Benfotiamine report a lessening 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

their neuropathy symptoms within 4 to 7 days, and Benfotiamine has been shown to be non-toxic and without any side effects even in very high dosage

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

Companies that provide selfless information through particip

.

You can start using Benfotiamine and decrease or eliminate these problems!

See: http://www.realfoodnutrients.com/neu/home.htm?sid=ezinearticle

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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