Useful Advices - Business

Some of the new-generation nitrogen generators use the APSA process to generate nitrogen. Th

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

is APSA process relies on the fractionated distillation of air at very low (cryogenic) tempe

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

Examples of combination products may in

ratures, and in only one column. In other words, APSA nitrogen generators are nitrogen gener

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

ators that use cryogenic distillation of air to generate nitrogen.

After the air is being c

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

ompressed, it is purified in the nitrogen generator, so that the cryogenic operation runs sm

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

Combination pro

oothly. The air is being compressed at around 9 bars with a centrifugal or a screw compresso

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

r and afterwards cooled down with the help of a cooling unit.

The air that runs through 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

nitrogen generator must then be purified, so it passes through several filters and cooled d

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

own some more.

Afterwards the criogenic process must intervene, so the air enters a special

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

area of the nitrogen generator, the cooling area, and then the oxygen in the air is separat

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

d from the nitrogen. At the bottom of the area there will be a liquid that is oxygen-rich an

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

Following aspects would a

d at the top the desired nitrogen.

The low temperature inside the nitrogen generator is man

dd to the challenges in developing combination products:

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

tained using a small quantity of liquid nitrogen, which is then added at the produced nitrog

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

en.

This process is designed so that it's all automatically controlled, it requires no manu

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

al procedures. If problems occur, the nitrogen generator is created so that it will try to s

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

olve them on its own.

For example, if the nitrogen consumption increases, a pressure regula

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

Professional from academic institutions, pharmaceutical industries, health care indust

tor will maintain the normal pressure. Or, if the concentration of oxygen is too high, the A

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

PSA process is automatically closed and the excess of oxygen is ventilated outside. Furtherm

.

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

ore, the nitrogen generator waits for the oxygen levels to decrease, and if they don't, the

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

Companies that provide selfless information through particip

whole system is shut down. When this occurs, the nitrogen generator takes safety precautions

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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