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If you are allergic to wheat then you suffer from Allergies Type 1, also called Contact Allergies. The allergic reaction to wheat intole

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

rance is caused by one or more of the 4 main groups of proteins found in wheat. The 4 proteins groups consist of, water-soluble, salt-so

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

Examples of combination products may in

uble, alcohol-soluble and alcohol-insoluble. Different proportion of the proteins is found in wheat depending on the type of wheat being

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

tested.

Scientists do not clearly understand why the immune system of people allergic to wheat considers some food proteins as harmful

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

y the body. The immune system can mount a variety of defenses mechanisms against proteins that is considers as harmful or foreign. Symp

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

Combination pro

oms can be very mild to life-threatening depending on the severity of your wheat allergies. They usually occur within a few minutes to a

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

few hours after eating or inhaling wheat.

The proteins found in wheat trigger the immune system to reaction. Antibodies and histamines

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

are releases into the blood stream in an attempt to neutralize the wheat protein. These chemicals trigger the allergic symptoms. In sev

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

r cases Epinephrine, also call Adrenaline, is administered to control the anaphylaxis reaction.

Except for specific groups, being allerg

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

ic to wheat is considered relatively uncommon. Up to 30 percent of people in the baking industry is believed to have developed occupatio

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

asthma because of allergies or intolerance to wheat and flower.

Diagnosis of wheat allergies is usually performed by appropriate labora

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

Following aspects would a

ory skin prick test. Self-diagnosis of wheat allergies can be done if a person has the same reaction every time after eating wheat-conta

dd to the challenges in developing combination products:

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

ining food. However the self-diagnosis is usually difficult because wheat is usually consumed with other foods and the type of wheat pro

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

eins varies greatly.

Avoidance of wheat-containing foods is the only effective treatment for people who are allergic to wheat. Avoidanc

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

can be very difficult because wheat protein is often hidden in other foods. Until a cure is found, read the labels of every food that y

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

ou bring into your home. Because the manufacturing processes change continuously re-read the labels each time you purchase a product. O

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

Professional from academic institutions, pharmaceutical industries, health care indust

January 1, 2006 a new law was passed stating that all labels should be designed in such a way that a 7 year old child could read and und

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

rstand the ingredients.

Avoid any food products that have Wheat, Bran, Bread Crumbs, Cereal Extract, Natural Flavoring, Starch, Vegetabl

.

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

e Gum, Soy Sauce, Gluten, or Enriched Flower on the label until you know if that particular item will give you an allergic reaction.

Alw

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

Companies that provide selfless information through particip

ys consult your doctor before using this information.

This Article is nutritional in nature and is not to be construed as medical advice

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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