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Coir Fibre is one of the oldest natural fibres found in the world today. It has been in using for mo

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

re a millennium though various coastal regions. Many household and industrial products are being mad

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

Examples of combination products may in

from this fibre. Coir is obtained from the fruit of the coconut tree. Strong water resistant fibres

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

cover the inner fruit of the coconut. The inner white flesh of the fruit inside is covered by brown

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

hard kernel. The fibrous layer forms a strong, shock-absorbing mesh which protects the seed from mec

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

Combination pro

anical damage and is water-resistant. The individual fibre cells are narrow and hollow, with thick w

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

lls made of cellulose. They are pale when immature but later they become hardened and yellowed when

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

a layer of lignin, a complex woody chemical, is deposited on their walls. Mature brown coir fibres c

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

ntain more lignin and less cellulose than fibres such as flax and cotton and so are stronger but les

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

flexible. White fibre is smoother and finer than the harder brown fibre but is also weaker. The coi

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

fibre is relatively water-proof and is the only natural fibre resistant to damage by salt water.

C

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

Following aspects would a

oconut trees are found throughout the coastal regions of different parts of the world. Some of the m

dd to the challenges in developing combination products:

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

in regions include the Indo-Malaysian region, on the Ivory Coast, Dahomey and Togo, West Africa and

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

n Mozambique, Kenya, Tanzania and Central and South America. Coconut palms are among the most useful

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

plants grown by people, providing valuable commodities in the form of copra (dried coconut flesh) a

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

d oil, as well as building material, thatch, food, drink and ornament. Total world coir fibre produc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion is 250,000 tonnes. The coir fibre industry is particularly important in some areas of the develo

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

ping world. India, mainly the coastal region of Kerala State, produces 60% of the total world supply

.

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

of white coir fibre. Sri Lanka produces 36% of the total world brown fibre output. Over 50% of the c

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

Companies that provide selfless information through particip

ir fibre produced annually throughout the world is consumed in the countries of origin, mainly India

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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