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In recent years, stand up pouches have taken the packaging world by storm. Available with or without a re-closea

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

ble zipper seal, a stand up pouch is a laminated film bag, usually of different types of plastic or a blend of p

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

Examples of combination products may in

lastic and aluminum foil. Manufacturers rave about the bags because they use so much less material than other tr

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

aditional packaging methods like cartons or boxes, and because they offer a tremendous opportunity for branding

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

and merchandising.

Available in a variety of shapes and sizes, stand up pouches have three fundamental measurem

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

Combination pro

ents: width, height, and bottom gusset. The bottom gusset is the additional material at the bottom of the bag wh

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

ich gives it its capacity for expansion. Stand up pouches can be made to meet your exact specifications, but typ

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

cally the bottom gusset of the pouch is one of three different styles: Round Bottom Gusset, K-Seal Bottom, or Pl

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

ow Bottom. Whichever you choose depends on the type of product you plan to house within it. Here is a brief desc

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

ription of each style to help you determine which is best for you:

ROUND BOTTOM GUSSET

In this style, the edge

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

of the gusset is welded to the sides of the supporting walls, giving the package the extra strength and support

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

Following aspects would a

it needs to stand up. Stand up pouches made with the round bottom gusset are considered the most common in the

dd to the challenges in developing combination products:

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

industry and are ideal for products weighing less than one pound.

K-SEAL BOTTOM

If your product exceeds a cert

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

ain weight, you may wish to consider using stand up pouches with a K-Seal bottom gusset. In this style, seals on

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

both sides rise at 30-degree angles from the bag. This takes stress off the seals on either side of the package,

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

and allows for additional volume.

PLOW BOTTOM

Also known as a corner seal, this style of stand up pouch is ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

de from just one piece of film so there is no seal at the gusset, making it especially popular with manufacturer

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

s of granular products like sugar or salt. In this style of stand up pouch, the product housed in the package si

.

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

ts directly on the shelf. It is ideal for products weighing more than one pound.

Whichever style you choose, th

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

Companies that provide selfless information through particip

ere is no question that by switching to the use of a stand up pouch, your profits are sure to stand at attention

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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