E-Articles - Health and Fitness

For many overweight Americans, the battle with their ever expanding waist-lines didn't begin with great fanfare. Too many long work hours and fast food dinners has led to a gradual increase in weight gain and,

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

eventually, a weight problem with serious health risks.

Within weeks, some of those pudgy Americans may reach for Phenocal, the over-the-counter weight loss aid for overweight adults.

The manufacturer, Phar

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

Examples of combination products may in

axa Labs, has been strategically laying the groundwork for the launch of the product in July. Copies of the self-help lifestyle program will accompany packages of Phenocal as the diet pill goes on sale nationw

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

de.

This new weight loss product claims to increase energy levels, boost metabolism, suppress and control appetite, reduce unhealthy food cravings, and maximize diet and exercise results among others. On top

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

f that, it boasts of being a natural, safe and effective weight loss supplement. Can it work for you?

The foundation of Phenocal is composed of an impressive core profile of fat burning and metabolic enhancin

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

Combination pro

ingredients. The product contains 250 mg of Hoodia Gordinii, a plant that has been used by African bushmen for over 20,000 years to reduce hunger and give them the energy for long desert trips. Hoodia's poten

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

ial as an anti-obesity drug is so strong that it even attracted Pfizer who had plans of synthesizing its active ingredients.

Phenocal also contains 250 mg of Green Tea extract whose health benefits have been

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

recognized in China for the past 5,000 years. Aside from burning fat as reported in the American Journal of Clinical Nutrition, green tea can also increase your energy and curb your appetite. Green tea is a po

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

itive addition to any fat burner because it's ability to elevate the metabolism and inhibit the action of the enzyme amylase.

Then there's garcinia cambogia, a yellowish pumpkin shaped fruit found in India an

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

parts of Asia. This is the source of hydroxycitric acid (HCA) that is found in many weight loss products. As reported in the Journal of Agriculture and Food Chemistry, extensive animal studies have shown that

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

HCA suppresses appetite and enhances fat-burning. This is due to the fact that HCA inhibits an enzyme called citrate lyase that helps turn excess carbohydrates into fat. By inhibiting this enzyme, the body spe

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

Following aspects would a

ds up carbohydrate oxidation, meaning more carbs are burned.

Phenocal likewise contains 7-keto-DHEA, a safe alternative to the controversial drug DHEA that has been linked to cancer. Dr. Henry Lardy of the Un

dd to the challenges in developing combination products:

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

versity of Wisconsin Department of Biochemistry said 7-keto is more potent than DHEA in stimulating liver enzymes responsible for thermogenesis (burning calories) without the nasty side effects of the latter.

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

ecent studies show that 7-keto also increased the activity of enzymes associated with metabolism, causing a dramatic impact in the way calories are burned. The University of Illinois Medical Center at Chicago

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

said that in one clinical trial involving healthy subjects with an average age of 44 years who were given a high-calorie diet, the group who received 100 milligrams of 7-keto twice daily lost a significant amo

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

nt of weight and body fat in four to eight weeks.

Glucomannan's role in weight loss is well established. In one study published in the International Journal of Obesity, 20 obese patients who received two 500-

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

Professional from academic institutions, pharmaceutical industries, health care indust

illigram tablets of glucomannan daily prior to each of the three meals who didn't change their eating or exercise habits lost an average of over 5 pounds over an eight-week period. Serum cholesterol and low-de

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

sity lipoprotein cholesterol were also significantly reduced and no adverse reactions were reported.

There's no magic bullet for losing weight. Eat healthier, low-calorie foods, watch portion sizes, and engag

.

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

in regular physical activity. While other diet products rely mainly on slick marketing techniques, sexy bodies, and a classy image to sell, Phenocal's strength lies in its solid proprietary base blend of ingr

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

Companies that provide selfless information through particip

dients. This product is not for everyone though. The product should not be used by adolescents less than 18 years of age. Also, the product appears to be best suited for those who are significantly overweight

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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