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1) Aluminum is light and highly robust: The density of aluminum is only 2,6 to 2,8 g/cm3. This is on

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

ly approx. 1/3rd of the density of steel. Despite its low weight aluminum is very strong.

2) Aluminu

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

Examples of combination products may in

is impermeable to moisture: Even under extremely long storage conditions moisture cannot diffuse thr

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

ough the material. Welding allows an aluminum case to be constructed so that it is impermeable to mois

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

ure vapour.

3) Aluminum is not sensitive to impact and is very strong: Although the surface may be

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

Combination pro

dented as a result of impact, the impact energy is however absorbed by the deformation.

4) Aluminum

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

s magnetically neutral: Aluminum is free of ferromagnetism. This material characteristic can be of gr

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

eat significance for certain application areas.

5) Aluminum is not even sensitive to extreme tempera

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

ure fluctuations: In the temperature range -150 to +150 °C the material characteristics remain consta

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

nt.

6) Aluminum is fully recyclable: Old aluminum can be melted down and reused – a decisive contri

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

ution towards relieving pressure on waste disposal and environmental protection.

7) Aluminum is corr

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

Following aspects would a

sion resistant and protects itself: On contact with oxygen the surface becomes covered with an oxide

dd to the challenges in developing combination products:

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

layer and this layer is immediately renewed if damage occurs.

8) Aluminum is resistant to UV radiati

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

n: Long storage periods and usage under exposure to UV-radiation have no influence on this material.

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

9) Aluminum is hygienic: The smooth surface is easy to clean and odour-neutral. Aluminum cases are

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

utstandingly well suited for areas with demanding specifications in relation to hygiene.

10) Aluminum

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

Professional from academic institutions, pharmaceutical industries, health care indust

can be machined in a number of different ways: All the most widely used machining processes – weldin

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

, moulding etc. can be used in conjunction with aluminum and can be carried out a great deal more effi

.

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

ciently than is the case with other materials.

11) Aluminum is conductive of electricity: Aluminum

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

Companies that provide selfless information through particip

s a good conductor of electricity and heat, an advantage e.g. in housings for electronic installations

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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