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Sodium Lauryl Sulphate (SLS): is one of the most commonly used foaming agent

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

s found in cosmetics. It is also used in car washes, garage floor cleaners and engi

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

Examples of combination products may in

e degreasers. It is a man made Non-Organic product.

Sodium Lauryl Sulphate is a ma

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

jor health concern because it is so common. It is found in over 90% of all foam pro

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

ucing products. There is a lot of debate as to how toxic it actually is, but there

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

Combination pro

re literally hundreds of scientific studies explaining its toxicity.

Sodium Lau

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

ryl Sulphate (SLS):

Can easily penetrate the skin

Is used in cli

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

ical studies as a skin irritant

Can damage the immune system causing sepa

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

ration of skin layers and severe irritation of the skin. When used on the scalp (sh

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

mpoos etc), long term exposure to SLS can cause hair loss due to corrosion of hair

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

ollicles.

Associated with the development of cataracts even with indirect

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

Following aspects would a

contact.

Sodium Laureth Sulphate (SLES) Sodium Lauryl "ether" Su

dd to the challenges in developing combination products:

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

fate, a close relative of SLS is an ether chain added to SLS. Called a “premium

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

” agent in cleaners and shampoo’s. The reality is, it is a very inexpensive product

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

but thickens when salt is added in the formula and produces high levels of foam to

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

ive the concentrated illusion it is thick, rich and expensive. It is used as a wett

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing agent in the textile industry. Irritating to scalp and may cause hair loss.

So

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

ium Lauryl Sulphate & Sodium Laureth Sulphate is a common ingredient and is availab

.

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

le in Baby shampoos. While many studies have been done on the effects of SLS & SLES

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

Companies that provide selfless information through particip

it remains the most common foaming agent available in Personal care products today

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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