I Advice - Health and Fitness

Cellulite is a skin concern. It is also called as orange peel syndrome or cottage cheese skin. In cel

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

lulite, dimples form mainly on the thighs. This is more of a problem in women than in men. Cellulite

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

Examples of combination products may in

has no known cure till now except some temporary solutions with massages. As many products are being

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

sold as a cure of cellulite, let us know more about cellulite.

Cellulite> what is cellulite?

Cellul

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

ite is the dimpled appearance that forms on the thighs and buttocks of most of the women, as they age

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

Combination pro

. Though most women carry their excess fat in thighs and buttocks, cellulite does not depend on weigh

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

t. You need not be overweight to get cellulite. Cellulite is more a problem of aging. It is something

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

similar to wrinkles that form on the face as you age. Cellulite forms due to less collagen and elast

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

in in your skin. Hormones play a major role in cellulite formation because men don't show cellulite.

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

The fat inside the cellulite is same as the fat in other parts of the body. There is no difference i

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

n the fat. So it is not a problem of any difference in fat. It is more a problem of how the fat is pl

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

Following aspects would a

aced inside the body, below the skin in thighs and buttocks.

Cellulite> treatment

There is no known

dd to the challenges in developing combination products:

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

cure for cellulite. Though many formulations are sold, claiming that they can cure cellulite, nothin

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

g is proved yet. Neither any pill, nor any cream can cure cellulite. Liposuction cannot cure cellulit

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

e. You can get a temporary cure of cellulite with massage such as endermologie (a deep mechanical mas

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

sage). But the effect may last for a very few days. Before you begin trying anything, talk to your do

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

Professional from academic institutions, pharmaceutical industries, health care indust

ctor.

This article is only for informative purposes. This article is not intended to be a medical ad

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

vise and it is not a substitute for professional medical advice. Please consult your doctor for your

.

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

medical concerns. Please follow any tip given in this article only after consulting your doctor. The

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

Companies that provide selfless information through particip

author is not liable for any outcome or damage resulting from information obtained from this article.

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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