E-Articles - Health and Fitness

The Largest and one of the most important organs in the body is the skin. A child’s skin, especially, provides a vast range of functions. First and foremos

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

t it provides a protective, waterproof layer for the bodies internal organs.

The skin also maintains the body’s temperature. When the skin gets too cold c

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

Examples of combination products may in

pillaries under the skin contract, preventing the flow of blood to the skin surface. On the flip side, if a child becomes too hot, the capillaries enlarge,

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

allowing blood flow to the skin surface. This increases heat loss and turns the skin red.

Nerve endings in your child’s skin respond to senses like warmth

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

pain, cold and touch. The skin responds to these stimulations, and sends information to the brain about the external environment the child is occupying.

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

Combination pro

he skin is made up of 4 basic segments:

Epidermis – The part of the skin we see. Basically made up of dead cells with a hard protein called ker

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

tin.

The Dermis – The thick inner layer of skin is made up of basically collagen. The dermis also consists of capillaries, sweat glands, s

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

baceous glands, hair follicles and nerve endings.

Hair - Hair begins its life as “vellus” (fine downy hair), covering most of the body of

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

baby at birth. Hair is usually not found on the palms of the hands or the soles of the feet. At puberty terminal hair develops around the genital area, ar

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

pits which adds to already present terminal hair on the scalp, eye brows and eye lashes. Males will also develop more hair than women at puberty. <

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

i>Nails - Nails look nothing like hair, even though they begin life from the same epidermal cells and they only differ from skin by the thickness of

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

Following aspects would a

the keratin..

A baby might be covered with vernix caseoasa which is a white, greasy coating that protects his or her skin in the uterus. This is was

dd to the challenges in developing combination products:

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

ed off or can be left to disappear on its own. A young baby’s skin is about 5 – 6 times thinner than an adults.

Unless prescribed by a physician, it is no

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

necessary to treat your child with expensive, chemical ladden, commercially formulated products. Organic Skin Care products are typically the best and ha

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

e the lowest allergy risks.

You can also use several home remedies for treating your child’s skin:

Honey - Will help draw puss from an infected wo

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

nd.
Eggs - Apply egg white to nappy rash. Apply in layers allowing each layer to dry prior to applying the next.
Cucumber - Great

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

Professional from academic institutions, pharmaceutical industries, health care indust

or cooling sunburn and minor insect stings.
Baking Soda - Can relieve itching from plant allergies and nettle rash. Make a past with a small a

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

ount of water. Apply to skin and leave for 20 – 30 minutes.
Onions - Have been known to relieve stings. Can also remove warts. Add onion juice

.

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

o warts twice daily.
Epsom Salts - (Same as baking soda)
Cabbage Leaves - Use as a poultice to relieve boils, blisters and stings.<

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

Companies that provide selfless information through particip

r> Lemon Juice - Known to be good for cold sores and wasp stings.
Tea - Good for cold sores. Using a T-Bag as a ready made compress.

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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