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Some medical conditions have no respect for age; the young or the old, and Acid Reflux, also known in medical terms as Gastroesophageal Reflux Disease

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

(GERD) seems to be one of them. The lower end of the esophagus is protected by a valve called the Lower Esophageal sphincter (LES). This valve open

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

Examples of combination products may in

to allow food from the esophagus into the stomach and then closes up to protect the esophagus from the acid content of the stomach. Several conditio

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

s can compromise this valve, allowing gastric content into the esophagus. As in adults, infants also suffer from heartburn on occasions. This is mai

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

ly attributed to the fact that infants consume essentially liquid and soft foods, which tend to be rich in diary proteins. The most unfortunate part

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

Combination pro

f infant acid reflux disease is that, unlike in adults, it is very difficult to determine if an infant has developed chronic gastroesophageal reflux d

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

isease. An infant is most unlikely to be able to complain of heartburn or any symptoms of the disease.

Acid reflux in infants is always as a result

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

f a lot of factors, however, most of the causative factors tend to be aggravated by the fact that infants, spend a great deal of their days lying on t

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

eir back or in a supine position and consume mostly liquid food. The tendency for liquid food to cause regurgitation, when combined with the pressure

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

lying in a supine position exerts on the lower esophageal sphincter (LES) constitutes a greater risk of reflux acid incidence in infants. The inciden

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

e, however, could also be attributed to some other factors like, the anatomy of the infant's stomach, improper or incomplete development of the lower

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

Following aspects would a

esophageal sphincter during fetal growth, poor diet, overweight, food allergies and a host of other factors.

Because infants, unlike adults, cannot c

dd to the challenges in developing combination products:

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

mplain of symptoms or explain how they feel, it is always very difficult to know when an infant is suffering from acid reflux. The best bet is to con

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

ult a pediatrician. Nevertheless, there are signs and clues that you may look out for in your infant that could suggest the presence of the disease.

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

Some of these clues are:

- Sleeping problems
- Coughing
- Weight loss
- Lack of appetite
- Spitting up frequently
- Apnea

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

br> - Unusual irritability
- Chest pain
- Sore throat
- Bad breath
- Crying

Acid reflux disease can also cause respiratory prob

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

Professional from academic institutions, pharmaceutical industries, health care indust

lems including pneumonia, strictures and ulcerations on the esophageal wall, and malnourishment. Although, these signs don't always mean your infant

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

s suffering from acid reflux disease, but they constitute a good enough reason to go see your pediatrician.

Of course, there are a few things you cou

.

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

d do to help your child avoid acid reflux. Simple things like changing the child's food, keeping him/her upright for some time, especially after eati

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

Companies that provide selfless information through particip

g, keeping a eye on the child for any sign of chest pain or heartburn and a host of others. This extra attention could be all your child really needs

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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