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A study regarding the correlation between pH and the irritant effect of soaps and cleansers marketed for dry skin reveal

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

ed that most products recommended for sensitive skin cause significant irritation to the protective surface layer of 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. Consequently, the authors of the study recommended that advertising regulations for sensitive skin products requir

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

e disclosure of the pH level and the type of cleansers used. However, it is still rare to find a dry skin product with t

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

e right pH level and it is wise to take measures to prevent damage. Shielding lotion, a new breakthrough in dry skin c

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

Combination pro

re now recommended by hundreds of dermatologists, protects the skin from such irritation.

The study, published in the I

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

nternational Journal of Dermatology, was conducted on 17 products marketed for dry skin and 12 common soaps. The product

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

were applied to the forearm of 30 participants for five consecutive days. The pH of each product was measured and the e

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

fects - including redness, scaling and fissures - were recorded and then scored using the Irritation Index. The authors

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

concluded that most of these products caused considerable irritation.

The pH level of normal skin is between 4 and 6.5,

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

which is slightly acidic. Dry skin care products with a pH in that range are generally safe. However, despite the recomm

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

Following aspects would a

ndations of this and other studies, most soaps have a pH of 9 to 11. Many moisturizers, toners, peels, lotions and other

dd to the challenges in developing combination products:

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

skin care products also tend to be either too acidic or too alkaline. Household cleansers, another major source of dry

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

kin and irritation, can have a pH as high as 13. In fact, it's virtually impossible to avoid products that cause skin da

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

age.

However, shielding lotion was designed to handle precisely that problem. According to Dr. Lisa Benest, a board cer

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

tified dermatologist practicing in Burbank, California, "Every day our skin is exposed to numerous chemicals and irritan

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

Professional from academic institutions, pharmaceutical industries, health care indust

s just in everyday life - you don't have to be working in chemicals or with cleaning fluids to have that happen. Shieldi

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

g lotion provides an invisible barrier onto the skin to help protect us from all these irritants, which can lead to dry

.

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

skin, eczema and other skin problems."

The best protection from irritation is to avoid the chemicals that cause it but,

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

Companies that provide selfless information through particip

for those that cannot be avoided, a shielding lotion gives the protection needed to both treat and help prevent dry skin

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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