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Titanium is an inert metal alloy that is usually combined with aluminum, steel, manganese and molyb

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

denum. A titanium alloy is almost as strong as steel but forty five percent lighter. Titanium faste

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

Examples of combination products may in

ners are used in the aircraft industry in a great quantity because they reduce the weight of the ai

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

craft and are corrosion resistant.

Titanium fasteners such as screws are also corrosion resistant

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

because of the oxide layer that forms on titanium alloys. This layer is the main reason for the ext

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

Combination pro

ensive use of titanium in many industries. An amazing fact about this layer is that it is automatic

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

lly replaced if scratched or removed. Fasteners and screws undergo tremendous amount of scratching

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

and friction and this is the reason why titanium is used in the manufacturing of such products.

Th

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

e oxide layer that forms on the fastener protects it from corrosion thus making it durable and stur

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

y. Titanium fasteners also include bolts, washers, nuts, and flanges. These types of fasteners are

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

used in sports, petrochemical industries, and oil industries. Another advantage of titanium is tha

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

Following aspects would a

t it is heavier compared to steel. This is an important feature in fasteners because a heavy fasten

dd to the challenges in developing combination products:

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

r or screw can hold more weight compared to a stainless steel fastener.

Titanium fasteners are als

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

o used in grand prix racecars' wheels. This is because of their lightweight and adherence propertie

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

s. A titanium screw will adhere to any surface after some time because of the oxide layer that form

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

automatically on the surface of the metal. Titanium also has astounding galvanizing properties, wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ich means that it can be mixed with many metals such as aluminum and steel to form an alloy that is

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

suitable for the purpose that it serves.

The price of titanium fasteners ranges from $0.45 to$10

.

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

er piece. The price varies according to the size and the metal that it is combined with. Titanium f

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

Companies that provide selfless information through particip

asteners are a good option for those who want the structure to be durable, stable, and long lasting

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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