Advice You - Business

The cold foiling process, as the name implies, involves foil blocking without the use of heat. Traditional hot stamping foils require heat and pressure to transfer the foil from the carrier film to the substrate being printed, whereas cold foiling does not.

A hot

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

foil generally consists of a polyester carrier, or, more rarely, polypropylene or cellulose film, a release layer, a lacquered layer, the colour which determines the shade of gold or coloured metallic effect, a layer of vacuum deposited aluminium and finally a siz

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

Examples of combination products may in

d layer to give adhesion to the printed stock. A cold foil has basically the same structure, though cold foiling usually requires a thinner aluminium layer, and the adhesive layer is not always necessary.

The hot stamping foil is applied to the stock by means of

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

a heated die, set at a temperature of between around 100 Celsius to over 200C, depending on the type of stamping press being used and the area being blocked. The heat activates both the adhesive layer and the release layer, and allows transfer of the foil from the

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

carrier film according to the design of the die.

A cold foil, on the other hand, requires no heat and adhesion is achieved by means of a completely different mechanism. In cold foiling the design is not applied by means of a heated die, but is printed in the form

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

Combination pro

a UV activated adhesive. Any printing technique can theoretically be used in cold foiling, though offset litho and flexo are the most common. The run is started, the design applied using UV adhesive from printing plate or blanket, web and cold foil are brought

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

together through a nip then the sandwich passed under UV lamps which cure the adhesive. The cold foil and print webs are separated and rewound. Since the UV has to penetrated the aluminium layer, this is thinner in cold foiling than with hot foiling. A cold foil

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

must have an optical density low enough for it to sufficiently transparent to UV light to allow it to cure the adhesive in the short time available.

So, in a nutshell, cold foiling involves printing an adhesive, nipping the cold foil sandwich to it, curing, then s

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

paration, leaving the foil adhered to the stock according the printed design of the adhesive.

Traditional cold foiling is normally reel-to-reel and used in the self-adhesive labelling industry, but recent developments have allowed a viable sheet-fed process to be

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

used.

Whatever method is used, cold foiling has yet to give the high shine of traditional hot foil stamping. The nip, composed of a metal roller and a rubber impression roller, has to spotlessly clean or pinholes will be seen in the finished result. Cold foil is p

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

one to pin-holing and other visual defects. The separation in cold foiling is crucial, as is flatness of the web. Cold foiling is particularly prone to creasing if the webs are not completely flat when brought together,

ADVANTAGES

The advantages of cold foiling

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

Following aspects would a

are:

1. In-line foiling. The cold foiling unit can be placed in-inline after the printing processes, and if required, between printing processes. In cold foiling, the process has been converted from a slow hot stamping process to a fast printing process using

dd to the challenges in developing combination products:

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

a cold foil. The printer therefore bypasses an additional relatively slow process through using a cold foil rather than a hot foil.

2. Fast set-up. The use of conventional printing methods such as offset allows fast set up of cold foil as against hot foil. T

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

ere is no packing required in cold foiling to ensure even pressure to the substrate since the cold foil is applied to a wet adhesive.

3. The expense of having metal dies cut is eliminated with cold foil. The cold foiling process becomes more attractive for shor

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

t runs, where previously dies costs could prohibit this.

4. Since we are using a printing process, there are fewer registration problems with cold foiling. The hot foil process frequently present problems in registration which require time to put right.

DISADV

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

NTAGES

1. Cold foil print quality is not as good as that from hot foil. The brightness is generally lacking and pinholes are frequently a problem.

2. Cold foiling requires complete cleanliness if surface defects are to be kept to a minimum, and the hardnes

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, cleanliness, alignment and pressure of the nip roller is extremely important.

3. The energy provided by the UV lamps must be properly maintained or the cold foil will not adhere to the partially cured adhesive. In cold foiling, the transmission of the UV en

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

rgy through the foil is critical. Problems can be experienced with deep cold foil colours which act as UV absorbers, and foiling to black and deep blue substrates can be difficult in cold foiling since these colours contain pigments which act as UV absorbers and t

.

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

hus leaves less energy to cure the adhesive. For these reasons many suppliers do not offer cold foil in deep shades.

All in all, though, cold foiling is growing in popularity due to the increased profitability it gives, especially in areas where the very highest q

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

Companies that provide selfless information through particip

ality of foiling is not necessary. The newer offset cold foiling techniques are rapidly gaining ground on the quality of traditional hot foils, which is why most hot stamping foil manufacturers now include cold foil in their portfolio.

Copyright 2006 Peter Nisbe

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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