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E-Articles - Curing Acid Reflux in Children and Infants
Acid reflux is often a common thing in children and infants. The spitting up and throwing up of food particles is a common thing that every mother
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
must be accustomed to. Acid reflux is a condition wherein the lower esophageal sphincter fails to function properly. Under the normal circumstanc
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
es , the lower esophageal sphincter , which acts like a valve between the esophagus and the stomach , closes tightly after allowing the food into
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the stomach. Thus , under no circumstances can the food re-enter the esophagus. Acid reflux is caused when the lower esophageal sphincter is not a
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ble to prevent the backflow of the acidic stomach content into the esophagus. The acidic content causes irritation in the esophagus and this is te
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
rmed as acid reflux.
One of the main reasons for acid reflux in infants and children is that the digestion system is not developed and hence it l
One of the main reasons for acid reflux in infants and children is that the digestion system is not developed and hence it l
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
eads to occurrence of acid reflux. Hence it is recommended not to overfeed infants. Normally, doctor’s advice should be sought before deciding upo
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
n the feeding quantity. For infants and children suffering from acid reflux, it is recommended that the feeding quantity should be reduced corresp
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
onding with an increase in the frequency of the feeding. One can also try to change the schedule of feeding the infant. Again the doctor should be
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
consulted before changing the schedule. Both these suggestions can be useful to control acidity.
Pressure on the abdomen also increases the inci
Pressure on the abdomen also increases the inci
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ence of acid reflux. Hence parents are advised to hold the baby in an upright position especially after feeding them. This allows the stomach to d
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
igest the food easily. Ideally, the infant should be held in an upright position for about 30 minutes. It is often observed that infants and child
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ren tend to sleep on their stomach. This puts strain on the stomach and increases the chances of acid reflux. Hence infants and children suffering
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
from acid reflux should be laid on their backs while sleeping.
Burping plays an important role in the control of acid reflux. Hence doctors reco
Burping plays an important role in the control of acid reflux. Hence doctors reco
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
mmend burping the baby after feeding it. Burping should be done 2-3 times while feeding the infant. Elevating the head of the crib is another way
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
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
to cure acid reflux in infants. Elevating the head prevents the acid from reaching the esophagus.
Medication is another option to cure acid reflu
Medication is another option to cure acid reflu
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
x in infants and children . One can try using H2-blockers like cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d). These drugs prevent the backflow of acid into the esophagus. One can also try using the proton-pump inhibitors, such as esomeprazole (Nexium),
.
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
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
omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex), and pantoprazole (Protonix). They decrease the level of acids produced in
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
the stomach.
Hence acid reflux in infants and children can be cured by making elementary changes in their dietary patterns and sleeping positions
Hence acid reflux in infants and children can be cured by making elementary changes in their dietary patterns and sleeping positions
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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