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MIXING: This is a process where all ingredients are put together in right propor

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

tion for dough formation.These ingredient are then fed into Mixers where mixing is

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

Examples of combination products may in

done and dough is prepared for molding .Major ingredients are flour , fat ,sugar

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

and others as per the product one would like to have.

MOULDING: In this section w

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

laminate the dough into sheet which then passes down to gauge rollers and sheet t

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

Combination pro

hickness achieved for cutting . Here we have a cutter or a moulder as per the vari

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

ety where one gets the shape and sizes of biscuits .

BAKING: This is the area whe

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

e we pass these moulded wet biscuit into baking oven .The biscuits are baked on de

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

sired temperature s.Various type of heating are available now days as per the conv

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

enience and cost .Different type ovens are available

COOLING: These baked biscuit

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

are then passed on to cooling conveyors for natural cooling prior to packing .The

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

Following aspects would a

temperatures are brought down to room temperatures

PACKING:These biscuit are the

dd to the challenges in developing combination products:

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

n stacked and fed into packing machine for packing .Different packing material are

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

available for packing of these biscuit in different packs .slug packs , pouch pa

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

k or family packs etc.These packs are then put into secondary packaging like cart

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

ons to be transported to retailers.

Raw material : flour , fat , sugar , lecithi

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

Professional from academic institutions, pharmaceutical industries, health care indust

n , salt , sodium bicarbonate , ammonium bicarbonate & flavours other ingredients

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

ould be nuts , cocoa , coconut powder , chocochips , onion , garlic etc

Packing

.

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

material : laminates , tapes , stickers etc

Plant and machinary : mixers , lam

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

Companies that provide selfless information through particip

inator , gauge rolls , ovens , conveyor , coders , packing machines, printers etc

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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