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Diaper rash usually looks like a patchwork of bright red skin on your baby’s bottom. Most babies develop a diaper rash sometime or another. Times di

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

aper rash may appear most often are:

• After solid foods are added to your baby’s diet
• When your baby is taking antibiotics
• When diaper

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

Examples of combination products may in

are changed infrequently

Diaper rashes are more common in babies during their first 15 months or anytime your baby wears diapers. Other factors tha

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

t contribute to diaper rash may include:

• Diarrhea
• Use of plastic pants to cover a diaper

The good news about most diaper rashes is most cas

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

s disappear after a few days with home treatment.

Signs and symptoms of diaper rash include:

• Red, puffy and sometimes slightly warmer skin in the

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

Combination pro

iaper region, buttocks, thighs and genitals
• Baby may seem more uncomfortable than usual especially during diaper changes
• Pain from a dia

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

per rash often makes a baby fuss or cry when the diaper area is washed or touched

Causes for diaper rash

If a baby is forced to wear diapers soiled

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

ith urine or feces for long periods of time, he or she can experience irritation. A baby’s skin is usually quite sensitive, but even an adult who wou

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

ld wear an undergarment soiled with urine or feces for long periods of time would eventually experience irritation.

Sometimes when babies start to ea

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

solid foods, the content of their stool changes and can increase the likelihood of diaper rash. Changes in baby’s diet can lead to increased frequen

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

y of stools, which can cause diaper rash. Breast-fed babies may develop diaper rash in response to something you have eaten.

New products such as a

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

Following aspects would a

new brand of disposable wipes, diaper or detergent can irritate baby’s bottom. Even the type of detergent or fabric softener you use could be the cau

dd to the challenges in developing combination products:

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

e.

Other substances that can add to the problem of diaper rash include ingredients found in:

• Baby lotions
• Baby powders
• Baby oils

Th

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

e diaper rash can begin as a simple skin infection then spread to the surrounding regions within the creases of the skin turning into a bacterial or y

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

ast infection.

Be careful about the fit of diapers and clothing. Tight fitting diapers and clothing which rubs against the skin can lead to diaper r

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

sh.

If your baby’s diaper rash does not improve within several days of home treatment and more frequent diaper changes, ask your health care provider

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

Professional from academic institutions, pharmaceutical industries, health care indust

for advice. If the diaper rash leads to a secondary infection it may require prescription medications. If diaper rash occurs with any of the follow

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

ng, have your child examined by a health care provider:

• Fever
• Blisters or boils
• A rash that extends beyond the diaper area
• Pus

.

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

or weeping discharge
• Rashes that don’t respond to home treatment

Source: Mayo Clinic

Written by: Connie Limon Visit us at http://smalldog

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

Companies that provide selfless information through particip

2.com/BabyHealth for an extensive list of FREE reprint articles about Babies and Baby Health.

This article is FREE to republish with the resource box

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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