Cases - Business

The process of producing plastic film by extruding molten resin into continu

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

ous tube is extremely simple. The elements of the process include plastic pe

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

Examples of combination products may in

lets (resin) which feed through the hopper into an opening on the back of an

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

extruder. Here, heat and friction from the screw and barrel inside of the e

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

truder convert the pellets to a melt which are forced through an annular, or

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

Combination pro

ring-shaped, die to form a tube.

The tube is inflated to increase its diam

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

ter and decrease the film gauge, and at the same time is drawn away from 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

die, also to decrease its gauge. The bubble is flattened by collapsing fram

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

s, drawn through nip rolls, over idler rolls to a winder which produces the

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

finished rolls of film.

The system is, in fact, one of the most complex and

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

sensitive of all plastics processing technologies and it presents many inher

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

Following aspects would a

ent difficulties. It would be fair to say that few who fully understands tho

dd to the challenges in developing combination products:

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

e difficulties would ever enter the business except for the fact that there

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

is a positive side to the picture. The tubular blown film process is efficie

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

t and economical, and can produce array of products from a light gauge, clea

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

r converter film to heavy gauge construction film, which when slit open may

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

Professional from academic institutions, pharmaceutical industries, health care indust

e 40 feet or more wide.

Conclusion is that you must maintain uniform roll d

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

iameters, weights and appearance that will indicate a consistency of product

.

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

that can only enhance the film to the customer. Finally a proper roll and or

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

Companies that provide selfless information through particip

package label will identify your good work so the customer can recognize it

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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