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Silicone (formally referred to as polymerized siloxane or polysiloxane) refers to any of a number of polymers containing alternate silicon and oxygen atoms,

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

whose properties are determined by the organic groups attached to the silicon atoms. Silicone is fluid, resinous, rubbery, extremely stable in high tempera

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

Examples of combination products may in

tures, and water-repellent, making them ideal for use as adhesives, lubricants, hydraulic oils and insulation in a broad array of fields.

One of the key el

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

ements of silicone is its ability to maintain it’s mechanical properties over a wide range of temperatures, -80° F - 400° F (60° C - 205° C) and in some cas

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

s normality can be sustained in an even broader range of temperatures.

Silicone is often mistakenly referred to as "silicon". Although silicones contain si

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

Combination pro

licon atoms, they are not made up exclusively of silicon, and have completely different physical characteristics from the element silicon.

Silicone gaskets

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

and pads are available in open cell foams, closed cell sponges, various durometer solids, and is readily molded in a wide variety of colors. There are high

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

tear strength silicones, reinforced silicones, electrically conductive silicones, and thermally conductive silicones.

There are silicone foams that are UL9

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

4-V0 rated which is commonly required in the transit and electronic sectors. It performs well in compression set tests, and silicone is also naturally UV re

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

sistant which makes it ideal for numerous outdoor applications.

Extreme temperature resistance, stability with extreme environmental and chemical stress, a

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

d durability are some of the reasons silicone benefits aviation and aerospace. Silicone rubber sealants are currently used to fasten interior and exterior d

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

Following aspects would a

oors, windows and paneling. Fluid resistance makes silicone ideal for fuel control diaphragms, hydraulic lines and cable clamp blocks. Silicone rubber keypa

dd to the challenges in developing combination products:

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

ds are even used in computers on earth and in space.

Silicone sealants are commonly used to seal gaps, joints, and crevices in buildings being constructed

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

or renovated. Both professional and retail grade silicones are abundantly available for this purpose. These one-part silicone sealants cure by absorbing atm

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

spheric moisture, which helps in the professional installation. A moistened finger or damp cloth is all that is needed to apply, and many do-it-yourselfers

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

typically use this method to apply silicone caulking. Similar methods work for urethane caulking, the largest competitor of silicone caulking.

Silicone dem

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

Professional from academic institutions, pharmaceutical industries, health care indust

and in the US will grow 4.7 percent annually through 2010, driven by performance and environmental advantages over acrylic, polyurethane, and rubber. Silico

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

e fluids have, and will continue to have the highest demand. Demand for silicone gels will grow faster based on renewed growth in the electronics sector.

S

.

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

ilicone gels are essential to the electronics sector, where highly specialized applications call for greater demands on the sealing materials. Silicone rubb

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

Companies that provide selfless information through particip

er is used to insulate, seal and protect circuits, engine gaskets, control unit gaskets, electronic encapsulation, and special elements for decoupling noise

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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Could the Crusades have been launched and the soldiers armed and fed without effective project management? Could the Great Wall have been built with ingenious natural materials and a team of millions over a span of a thousand years without project management? It is possible to say that the concept pf project management has been around since the beginning of history.

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