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Freckles are flat, circular spots that typically range in the size of the head of a nail. Freckles are small t

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

an spots of melanin on the skin of people with fair complexions. The word "freckle" comes from the Middle Engl

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

Examples of combination products may in

sh "freken," which, in turn, came from the Old Norse "freknur," meaning "freckled." Freckles are small browni

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

h spots on human skin, predominantly found on the face. Freckles discrete specks or spots which develop over s

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

n-exposed surfaces, particularly the cheeks and nose. The basic cause of freckles is special cells in the skin

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

Combination pro

that produce a pigment called melanin. Excessive build-up of melanin in one place will result in freckles. Fre

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

kles are small flat brown marks arising on the face and other sun exposed areas. They are seen in children and

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

in fair skinned people especially those with red hair who have an inherited predisposition for them.

There ar

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

two basic types of freckles first is ephelides and second is lentigines Ephelides flat spots that are red or

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

light-brown and typically appear during the sunny months and fade in the winter. They are most often found in

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

eople with light complexions and in some families, they are an hereditary (genetic) trait. Lentigines (singula

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

Following aspects would a

r: lentigo, from the Latin word for lentil): Children may develop a small tan, brown, or black spot which tend

dd to the challenges in developing combination products:

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

to be darker than an ephelis-type freckle and which does not fade in the winter. This kind of spot is referre

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

to as lentigo simplex. Lentigines are part of a rare genetic syndrome, for the most part they are just isolat

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

d and unimportant spots.

Causes of Freckles

1.Skin pigment melanin.

2.Sunlight.

3.Sun exposure.

4.Genetic

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

factor (MC1R gene ).

Symptoms of Freckles

1.Brown spots on the face.

2.Red-hair.

3.Diarrhea.

4.Moles are

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

Professional from academic institutions, pharmaceutical industries, health care indust

ften produced at the affected area of skin.

5.Abdominal pain.

6. Weight loss.

Treatment of Freckles

1.Blea

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

hing creams

2.Tretinoin

3.Cryosurgery

4.Laser treatment Several lasers, especially ones that produce a gre

.

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

n light, can lighten and eliminate freckles safely and effectively.

5.Intense Pulsed Light Therapy (IPL).

6.

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

Companies that provide selfless information through particip

orseradish juice or horseradish vinegar, or oatmeal dabbed on the skin are also helpful in lightening freckles

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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