E-Articles - Health and Fitness

Obesity, a body mass index (BMI) greater than 30.0 kg/m squared has become a worldwide epidemic. Nearly one-third of the population in the US is obese and another one-third of the adult population is overweight (BMI 25.0 - 29.9 kg/m squared).

The incidence of severe obesit

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

y (BMI greater than 40 kg/m squared) more than doubled during the decade of the 90’s. The consequences to one’s health for being overweight include increased risk of developing:

Heart disease
High blood pressure
Type 2 diabetes
Elevated blood lipids
Certain

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

Examples of combination products may in

ancers
Muscle and skeletal disorders
Sleep apnea
Complications in pregnancy
Depression and other psychological problems

The total direct (healthcare) and indirect (lost productivity) costs were estimated to be a staggering $117 billon in 2000, or about one-half

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

of the total costs caused by hurricane Katrina, the worst natural disaster in the history of the USA. The real difference between the costs for Katrina and for obesity might best be described as the difference between a one-time and an ever increasing recurring expense. In the

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

bsence of effective treatment, the costs of obesity cannot help but do severe damage to the economy.

Fiber is defined as a dietary constituent that is not degraded into absorbable units within the stomach or small intestine. Soluble fibers are more soluble in water relati

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

Combination pro

ve to insoluble fibers. To further classify dietary fiber it is said that they are either fermentable or nonfermentable, depending on whether or not undigested fibers are consumed by the microbes contained in the large bowel; this fermentation is the source of the gas and hence m

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

ch locker-room humor that accompanies a high fiber diet.

The idea of increasing dietary fiber for weight management and promotion of good health is not a new one. A recent study has indicated that a daily increase of 10 grams of dietary fiber intake lowers the risk of coronary

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

vents by 12% and coronary deaths by 19%. Interestingly, this study also found that obese individuals have significantly higher fat and lower fiber consumption compared to normal weight individuals; furthermore that there is no difference in energy intake between the obese and nor

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

al weight individuals. We might conclude from this that the difference in body weight, between normal and obese individuals, has more to do with fat than energy consumption. Some researchers have concluded that by increasing daily fiber intake by 14 grams reduces energy intake

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

by 10% and causes a decrease in body weight. The weight reducing effect of dietary fiber was found to be more pronounced in obese than in normal weight individuals.

There are numerous products available from nutritional food supplement stores, pharmacies and supermarkets, not t

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

mention a plethora of websites that contain either specific fibers or combinations of fibers. Almost all of these products guarantee your satisfaction, but not necessarily your weight loss. All of these products base their (inferred) weight loss claims upon one of two concepts;

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

Following aspects would a

fiber as a fat absorber or fiber as a bulking agent that increases your feeling of fullness. Until the introduction of FBCx none of these claims have been substantiated in the scientific literature.

Weight management is really not rocket science; it is simply a matter of

dd to the challenges in developing combination products:

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

alancing energy intake with energy required. Unfortunately, as your mother may have told you, the devil is in the details. The culture that we have embraced in the West and which we are rapidly exporting around the world, demands plenty of inexpensive, good tasting, high energy

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

food and as little physical labor/activity as is possible. The result is that we tend to eat more calories than we need causing our bodies to store the unused calories as fat. In order to lose excess weight and then maintain a desired weight requires a lifestyle change that is

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

so great that most of us will not even consider it, and those of us that do usually last only about 60-90 days on our Spartan regime. If you can do it, go for it and relish the fact that you are in a very elite club of very disciplined individuals. It is with these obstacles to

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

eight management in mind that we developed FBCx.

FBCx is a soluble, all natural, clinically tested, dietary fiber that is considered to be safe for human consumption at any level by the WHO (World health Organization) and has GRAS (Generally Recognized As Safe) status in t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e USA. FBCx is unlike any other fiber that we know of in that it has the very unique ability to form a stable complex with and reduce the bioavailability of nine times its own weight in dietary fat. Taking six one-gram tablets of FBCx as directed with fat containing meals effect

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

ively eliminates about 54 grams of fat or the equivalent of 500 kcal from a normal North American diet with no known side effects. Thus if your diet and weight is more or less constant prior to starting FBCx, you should be able to lose 3,500 kcal (7?500 per day) or 1-1? pounds o

.

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

body weight per week. This 1-1? pounds per week may not sound like much but it is what is considered to be a safe rate and when you multiply it by 52 weeks in a year, it quickly becomes significant. During 2005 we presented our clinical trial data at the American Diabetes Assoc

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

Companies that provide selfless information through particip

ation and the North American Association for the Study of Obesity annual meetings.

Is FBCx the miracle-in-a-bottle that is going to solve the obesity epidemic? Probably not, but used as directed it is a safe and effective means of reducing and maintaining your body weight

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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