E-Articles - Health and Fitness

Skin acre does not only mean keeping skin clean, using skin care products, applying cosmetics, avoidi

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

ng sun and getting surgery done for skin blemishes. Acid mantle of the skin plays a major role in pro

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

Examples of combination products may in

ection of skin and must be understood for better skin care. Let us find out more about what is acid m

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

ntle and what role it plays in skin care.

What is acid mantle?

Skin has a protective layer of acidi

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

oils on it, called the acid mantle. This protective layer is found all over the skin. Acid mantle is

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

Combination pro

a mixture of sweat and sebum. Disturbing this acidic mantle may cause many problems. That is why, we

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

ear so much about pH balanced products. Acid mantle-

1. Hydrates the skin and protects it from dryin

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

g.

2. Protects skin against harmful bacteria. Bacteria do not survive in the acidic mixture and ther

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

fore cannot cause infection in the skin.

How acid mantle is destroyed?

If you strip the skin of its

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

acidic mantle by using strong alkaline soaps/cleansers, bacteria will find it easy to attack the skin

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

Moreover removing the acid mantle disturbs the distribution of dead cells on top of epidermis. This

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

Following aspects would a

s called stratum corneum. The structure of cells in the dead skin cells layer gets disturbed and the

dd to the challenges in developing combination products:

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

acteria find an easy passage through to the epidermis. Normally these dead cells protect the skin aga

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

nst such damages. The skin is a miracle. These dead cells if allowed to accumulate will make the skin

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

look very bad, but if totally removed, the skin is left defenseless to an extent. We have to arrive

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

t a fine balance in maintenance of the skin. In the next part we will discuss about how to protect ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

d mantle.

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

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

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

.

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

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

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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