E-Articles - Health and Fitness

It’s a hot, summer’s day and you can’t wait to go to your favorite ice cream shop. There’s a long line but you are craving the sweet, cold, cream

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

y taste of your favorite flavor of ice cream. You finally reach the front of the line, order up your double cone of cherry chocolate chip and pis

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

Examples of combination products may in

achio, pay the cashier, step outside and proceed to gobble down too many mouthfuls of the delicious treat. Suddenly, your head starts to throb; y

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

ou realize quickly you have BRAIN FREEZE. This is the most common type of headache, affecting 1/3rd of the population, exclusive of whether you h

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

ve problems with other types of headache; chances are such that you have experienced the ice cream headache.

So why does this happen, you ask? I

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

Combination pro

e cream headache occurs when a cold substance such as a milkshake, ice cream, slushie or snow cone is ingested too quickly, alerting the mouth an

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

d throat region of a radical change in body heat. This in turn constricts the blood vessels, changing the flow of blood to the brain and causing

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

pain in the forehead for 30-60 seconds on average. The pain is a stabbing, sharp kind of pain that rarely persists longer than 2-5 minutes. On o

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

ccasion, migraine sufferers may notice an onset of a migraine after this type of rapid pain. The ice cream headache occurs when the weather is ho

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

and the body is warm. The cold temperature of the ice cream reaching the posterior aspect of the palate is the location in the mouth where the s

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

fferer can expect the ice cream headache to be triggered. The vasoconstriction that occurs reduces blood flow and minimizes heat loss from the re

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

Following aspects would a

st of the body. Within seconds, the blood vessels return to normal dilation and the nerves cease sending pain sensation to the forehead, unilater

dd to the challenges in developing combination products:

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

lly in the frontal, temporal or retro-orbital region.

Ice cream headaches signal no long-term vulnerability or susceptibility to other types of

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

headaches and are not serious or life threatening. They are an unpleasant, short-lived result of ingesting a cold substance too quickly. The pain

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

can be minimized or avoided by eating or drinking slowly, allowing the body to become accustomed to the change in temperature from the cold stimu

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

us. An effective trick to alleviate the pain after the onset of the brain freeze is to place the tongue on the roof of the mouth, warming the reg

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion and stopping the pain. Other options for assistance are to slowly sip warm water, create a heat mask over the mouth and nose with the hands b

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

breathing quickly to warm the area and tilting the head to the side may also offer some relief.

The good news for all lovers of ice cream and c

.

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

old treats on hot days is that abstinence from ice cream is not recommended by doctors! If a person notices an increase in the incidence of ice c

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

Companies that provide selfless information through particip

eam headache or if brain freeze seems to occur more than normal, consult your doctor for possible treatment and further discussion of your health

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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