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Spain is not at the top of the list of countries known for their blueberry production. But thanks to the research done by scientists at the University of Barcelona on the

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

benefits blueberries provide in the fight against age-related brain function deficits, Spanish growers are seriously engaged in increasing production of the dusky blue frui

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

Examples of combination products may in

ts.

In April of 2005, the Barcelona researchers published a study which showed that blueberries are not only loaded with brain-function improving phytonutrients; those sam

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

e phytonutrients were permeating the blood-brain barrier in the rats to which blueberry extract had been fed.

Those rats, as a result, had the memory and learning centers

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

of their brains awash in stimulating substances. The findings, presented in the April 2005 issue of Nutritional Neuro-science, said that the rats were given blueberry extr

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

Combination pro

act for between eight to ten weeks.

And four months later, the Barcelona scientists were back, this time in the August issue of Pharmacological Research. They tested old

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

rats which had received blueberry extract for thirty days, and found their cognitive performance had improved. One of their conclusions was that blueberries may contain su

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

bstances useful in preventing the memory failure which often accompanies aging in humans.

The findings of both studies were highly significant; the first, because earlier

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

research had established that blueberries had substances effective in reversing the age-related decrease in the brain’s neuron-signaling capacity. But it was not known if

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

those constituents actually penetrated the blood-brain barrier.

The second study was significant because it supported the findings of 1999 research done at Tufts Universit

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

y in Boston. The Tufts study showed that rats which had been fed blueberry extract from the age of six months had less severe declines in cognitive and neuronal capacities

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

Following aspects would a

as they aged.

Even more remarkable, rats which did not receive the blueberry extract until the age of nineteen months experienced a reversal of their age-related cognitiv

dd to the challenges in developing combination products:

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

e failure. The Tufts research seems to indicate that blueberries, and other foods with high concentrations of anti-oxidants, may be effective in turning back the clock on

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

age-related mental deterioration.

And those benefits apparently don’t stop with preventing or reversing memory and cognitive loss. Blueberries, according to a May 2005 st

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

udy in the Journal of Experimental Neurology>, may even reverse the effects of blood deprivation in the brain, like that experienced with strokes.

The study, performed by

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

researchers at the U.S. National Institute on Drug Abuse and the University of South Florida Hospital, showed that rats on diets containing blueberries, spinach, or spir

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

Professional from academic institutions, pharmaceutical industries, health care indust

ulina not only had significantly fewer brain cells, and smaller areas of their brains, damaged following a blood flow interruption; they also recovered a much greater capa

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

city for movement.

Blueberries are rapidly establishing themselves as the nutritional “bluebloods” of the fruit and vegetable kingdom. Ongoing research into their nearly

.

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

miraculous potential shows that they restore the speed with which old rats react to sounds, they help keep arteries relaxed under stress, reducing both the high blood press

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

Companies that provide selfless information through particip

ure and the arteriosclerosis which can lead to strokes, and, as the aforementioned study shows, help reduce brain damage from strokes themselves.

Food for thought, indeed.

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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