E-Articles - Health and Fitness

Photo rejuvenation is one of the latest innovative technologies in skin care. Although light therapy has been used extensively for more than 4

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

0 years for the treatment of conditions ranging from jaundice to depression, it has only recently become popular as a means of rejuvenating the

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

Examples of combination products may in

skin. Lasers, intense pulsed light (IPL), and light-emitting diodes (LEDs), are the common light therapies available today.

The different ty

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

pes of light are defined by their wavelengths:

ULTRAVIOLET LIGHT is invisible to the naked eye and possesses a wavelength of 0 to 400 nanomete

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

rs (nm). It is this type of light that causes skin damage such as sunburn and photo aging.

VISIBLE LIGHT is that which is given off by daylig

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

Combination pro

ht and standard light bulbs. This type of light is made up of multiple wavelengths ranging from 400 nm to 765 nm. Combined, they make up whit

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

e light that when diffracted, show the colors of the rainbow.

INFRARED LIGHT, like UV light, is invisible to the naked eye with wavelengths me

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

asuring 765 nm to 10,600 nm.

The wavelengths that are most commonly used for skin photo rejuvenation are in the range of 400-10,600 nm.

Laser

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

s and intense pulsed light are procedures that work by causing thermal damage to the skin and/or underlying tissues. They are potentially dange

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

rous, very costly, and must be administered by licensed professionals. Therefore, they are beyond the realm of discussion for this article. 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 contrast, LED devices can be sold to and used by anyone. Like lasers and IPL, they can be used to rejuvenate the skin although not as dramat

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

Following aspects would a

ically as the medical procedures.

LED therapy is a form of phototherapy and may also be referred to as photomodulation, low-level laser thera

dd to the challenges in developing combination products:

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

py, low-energy laser therapy, or light therapy. It is NOT the high-energy laser mentioned above that can be used only by trained professionals

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

. Its use for skin rejuvenation is based on the premise that when low energy laser light passes through the skin, different components of the

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

skin and its cells are effected, stimulating beneficial outcomes.

LED therapy activates the body’s own natural rejuvenation processes to count

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

eract the signs of aging by:

1. Stimulating fibroblasts to produce collagen resulting in the improvement of skin elasticity, fine lines, scar

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

Professional from academic institutions, pharmaceutical industries, health care indust

tissue and skin thickness.

2. Promoting skin circulation.

3. Increasing lymph activity and reducing fluid buildup. It is the lymphatic sy

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

stem that is responsible for helping the body eliminate waste products.

4. Stimulating the production of ATP, the energy source required for

.

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

all cellular functions.

5. Stimulating DNA and RNA synthesis to improve the reproduction of healthy cells.

6. Activating the release of gro

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

Companies that provide selfless information through particip

wth factors that stimulate cell growth and metabolism.

LED equipment for home use is now being manufactured specifically for cosmetic purposes

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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