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The skin is a vital organ covering the entire outside of the body thereby protecting it against heat, light, injury, and infection. It is the body’s la

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

rgest organ. It is only about 2 millimeters thick and weighs approximately 6 pounds.

The skin is composed of two layers that cover a third fatty layer

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

Examples of combination products may in

.

THE EPIDERMIS

The epidermis is the outermost layer of the skin and is responsible for protecting the body from the enviroment. Its thickness varies

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

on different parts of the body. For instance, it is only .05 millimeters thick on the eyelids and is 1.5 millimeters thick on the palms and the soles

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 the feet.

The epidermis is made up of five sublayers that work together to continually rebuild the skin’s surface.

The innermost layer of the epide

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

Combination pro

rmis is the basal layer. The cells in this layer continually divide, producing new cells that constantly push older ones up to the surface of the skin,

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

where they are eventually shed. This layer also contains the cells that are responsible for our skin’s pigments, called melanin. Patches of melanin c

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

ause birthmarks, freckles, and age spots.

The squamous cell layer is above the basal layer and is the thickest layer of the epidermis. This layer cont

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

ains the basal cells that have been pushed upward. These cells are now called squamous cells and produce the tough, protective protein that makes up th

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

e majority of the skin’s structure.

As the cells from the squamous layer are pushed up even further, through two more thin epidermal layers, they get b

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

igger, flatter, and adhere together. Eventually they become dehydrated, die, and continue to migrate to the surface of the skin.

The outermost layer o

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

Following aspects would a

f the epidermis is called the stratum corneum. It is made up of 10 to 30 thin layers of continually shedding dead skin cells. This shedding process, w

dd to the challenges in developing combination products:

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

here worn down cells are replaced by new layers of long-wearing ones slows down with age. Cell turnover takes 28 to 30 days to occur in young adults bu

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

t requires 45 to 50 days in older individuals.

THE DERMIS

Located beneath the epidermis is the thickest of the three layers of the skin, the dermis.

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

Much of the body’s water supply is stored here. It contains most of the skin’s specialized structures including, but not limited to:

* Blood vessels

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

- to supply the epidermis with nutrient-saturated blood.

* Sebaceous glands - that secrete oil that helps keep the skin smooth and supple.

* Col

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

Professional from academic institutions, pharmaceutical industries, health care indust

lagen - is the protein that holds the dermis together and is made by cells called fibroblasts. In the skin, collagen supports the epidermis, giving it

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

its durability.

* Elastin - is a protein similar to collagen that allow the skin to snap back into place when stretched giving it its elasticity.

TH

.

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

E SUBCUTIS

The subcutis, or hypodermis, is the innermost layer of the skin and consists of fat and collagen cells. Its thickness varies throughout the

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

Companies that provide selfless information through particip

body and from person to person.

The above information should help you to assess anti-aging product ingredients and the aging skin issues they address.

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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