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Despite the best efforts of modern science, your car tires rarely last as long as you keep your car. At some time, they will wear out or become damag

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

ed and you will have to replace them. Many years ago, most people changed their own tires. Back then, old tires were a recycling nightmare. They we

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

Examples of combination products may in

e almost universally banned from city dumps and landfills. Having no other options available many people would simply chuck their old tires into a ro

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

dside ditch at night when no one was looking. Those few companies that were willing to take your old tires often would end up burning them. Burning

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

tires, however, is an environmental disaster in almost every sense of the word. Arsenic, mercury, cadmium, lead, beryllium, chromium and other toxic

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

Combination pro

nd carcinogenic substances and dioxins are released into the air when a car tire is burned. Cardiac disease and respiratory problems can be caused by

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

the metal particles released from a burning tire as well. Plus the natural resources that go into making a tire go to waste if the tire is burned.

T

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

oday all of that has changed. It had to change there really were no other options. It is estimated that 1.3 billion tires are sold every year and mo

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

e than two thirds of those tires replace old worn out tires. That means that almost 1 billion tires worldwide are discarded annually. 20 years ago o

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

ly 10 percent of all discarded tires were recycled but today more than 80 percent make it to a recycling facility. Recycling the material in old tire

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

is a good idea no matter how you look at it and literally 100s of applications have been developed for recycling old car tires.

Almost no one change

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

Following aspects would a

s their own tires anymore and the recycling of old tires is done by professionals who generally do so in an environmentally safe way. When you take y

dd to the challenges in developing combination products:

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

ur car in to have the tires changed at the local garage or tire shop there is almost always provision for taking your old tires for recycling. Approx

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

mately 1 in 4 of those old tires is retreaded and used again on another automobile somewhere. In many parts of the world old tires are ground up and

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

used to make rubberized asphalt for highways or shredded and used as a base for gravel roads or as a sand or gravel substitute in some other road cons

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

ruction application. Some old tires are chopped up and used as part of the surface for indoor tennis courts or other indoor sports playing fields. F

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

Professional from academic institutions, pharmaceutical industries, health care indust

r many applications, recycling old tire rubber is cheaper than collecting and processing new rubber.

The burning of tires has not completely disappea

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

red but it has improved to the point where it is both environmentally safe and it recycles the raw materials. By using a process called pyrolysis, wh

.

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

ch burns the tires in a reduced air environment or vacuum, the raw materials are recovered and recycled. A typical car passenger tire will yield one

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

Companies that provide selfless information through particip

ilogram of steel, four liters of oil, almost four kilograms of carbon and 850 liters of reusable combustible gas as a result of this recycling process

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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