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In an effort to discuss some very new and extremely effective ingredients used

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

in today’s skin care products, we begin a new series of articles entitled “B

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

Examples of combination products may in

autiful Ingredients”. The first ingredient we will explore is lactic acid, an

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

ingredient used in a variety of products that range from professionally admini

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

tered Lactic Peels to more mild formulations that can be used at home.

I had

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

Combination pro

always thought lactic acid was that stuff that made my thighs burn when I ran

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

or a bus, but when used cosmetically, it becomes a popular ingredient used in

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

exfoliators. In a nutshell, lactic acid, a member of the Alpha Hydroxy Acids (

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

HA) family, is derived from milk and when fermented, becomes a powerful but ge

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

ntle exfoliating ingredient. Because of its ease of skin penetration, lactic a

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

id is one of the most effective AHAs to be used in cleansers, masks and anti-a

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

Following aspects would a

ing skin care creams. It is said the use of lactic acid goes all the way back

dd to the challenges in developing combination products:

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

to Cleopatra who was reported to bathe in sour milk.

Because lactic acid is a

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

naturally occurring human metabolite, there is much lower chance of allergic r

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

eaction using this type exfoliation and is an excellent ingredient for those w

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

th sensitive skin, rosecea or acne. One with sensitive skin should use caution

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

Professional from academic institutions, pharmaceutical industries, health care indust

when using a higher strength lactic acid product as it can cause unwanted sid

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

effects such as sensitivity to sun exposure.

While the name includes the wor

.

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

d “acid”, lactic acid is, in fact, a preferred exfoliating ingredient and is v

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

Companies that provide selfless information through particip

ry safe when used in conjunction with recommended dosages and frequency of use

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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