E-Articles - Health and Fitness

After a few hours of wearing contact lens your eyes tend to dry up and you will feel scratchy. This hap

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

pens because contact lenses are foreign bodies lodged in your eyes, which is completely unacceptable to

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

Examples of combination products may in

the body. The body, therefore, reacts to its presence by fighting the contacts with proteins and lipids

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

which builds protein deposits on the contacts thereby creating friction and dryness.

In other words,

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

he user of the contacts finds himself caught in the battle between the body and the lenses like an inno

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

Combination pro

ent civilian in the middle of a battlefield.

It is in order to circumvent this difficulty that proclea

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

lenses have stepped in. A substance called phosphorylcholine (PC for short) is found naturally in the

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

ody. This substance is used to make biocompatible lenses, which remain moist and dry throughout the day

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

They are different from ordinary contact lenses primarily because due to the presence of PC the body a

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

cepts them more easily and does not react to its presence. In other words, despite being a foreign body

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

it does not appear and feel foreign to the body.

Secondly, they preserve moisture and are, to a large

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

Following aspects would a

extent, resistant to dehydration, which makes them stay moist all day long. Besides, they also have a

dd to the challenges in developing combination products:

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

ater layer which bars the protein and lipid deposition.

Most of the itching and irritation in the eyes

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

is caused due to protein deposition which is a result of restricted oxygen supply through the lens. Th

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

proclear lenses disallow the deposition, thus facilitating the supply of oxygen. These lenses are an i

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

novation in the field of contact lenses and have so far been found to work to the utmost satisfaction o

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

Professional from academic institutions, pharmaceutical industries, health care indust

the users. However, the comfort level may fluctuate among the users, which means some may be more sati

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

fied than the others.

So, if you are unhappy with your present contacts, you may consider switching to

.

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

the proclear kind, which might prove a boon right from the blues. It is, however, recommended that befo

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

Companies that provide selfless information through particip

e switching over you consult your eye specialist so that he could advice you on the pros and cons of it

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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