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Coir fibers are extracted from the fruit coconut. It grows in the part between the husk of the coconut and its outer shell. The color of this fiber is golden, therefore it is also known as ‘Golden Fiber’. However they are not initially golden in color, but of pale color. At later stage when fibers become ha

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

rd, they acquire yellowish-golden color because of the lignin deposits on its walls. Its structure is narrow and hollow.

Coir fibers are water-proof in nature, also to the sea water, which is a distinguishable property. There are mainly two types of coir - white coir and brown coir. For processing of white

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

Examples of combination products may in

coir both sea and fresh water is used, whereas for brown coir fresh water is used.

Properties of coir

- It is a bad conductor of heat. It provides padding against extreme temperatures and sound.

- It is easy to wash and clean, which makes them highly durable and maintenance free.

- It is unaffected by

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

fungi, rot and other moths. As it is resistant to moisture the growth of micro-organisms is barred.

- Even if it is used for many years it does not loose its shape easily.

Types of coir

The types of coir - brown coir and white coir are categorized on the basis of the stage of the fruit when they are extr

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

cted from it, i.e. whether the coir is extracted from an immature coconut or fully ripped one. White coir is extracted from the husks of coconut which is not fully ripen and it is comparatively less stronger and more softer. Brown coir is extracted from the husks of coconut which is 100% ripened.

- White c

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

Combination pro

oir

As it is derived from immature husks, these husks are submerged in water for about ten month’s time. In this time period the plant tissues covering the coir fibers break down due to chemical reactions of the micro-organisms. Then the husks are hand beaten which separates the long fibers. The fibers fur

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

ther are dried in the sun, cleaned and sent for spinning where they are converted into yarn. These yarns are useful for making ropes, mats, etc.

- Brown coir

The husks are immersed into the slow flowing water, were the fibers get swollen as a result become soft. The long fibers and shorter fibers are sepa

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

rated from each other. The shorter fibers are also known as mattress fibers and longer ones are known as bristle fibers. They are first cleaned, sun dried and packed. Coir fibers are wavy in structure and have elasticity. The ropes are made by twisting these fibers. The long fibers are cleaned by water, dri

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

d in the sun and made into bundles. They are then made straight by steel combs and dyed with the desired colors.

The procedure for obtaining coir

Harvesting of the fiber

The coconuts are obtained from the trees, fetched by the climber with the help of the bamboo pole and a knife. As it is described earli

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

er the two types of coir are extracted from different stages of the coconut, the unripe coconut are allowed to dry in the sun for about a month. Whereas the fully ripened coconuts are husked as soon as they are fetched from the tree, then the fruit is separated from the seed. Earlier this work was done only

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

manually but now-a-days husking machines do this work at many places.

Retting of the fiber

Retting is a procedure where the husks are decomposed in either salt water or fresh water, encouraging the growth of micro-organisms. At this stage the coir fibers separate from the husk leaving behind residue whic

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

Following aspects would a

h is known as coir pith. Retting in salt water is used for unripe coconut husks and fresh water for ripe coconut husks.

Salt water retting requires the unripe green husks to be soaked in saline water. Generally they are soaked in pits near the ocean. This method takes about 8-10 months time duration. If mi

dd to the challenges in developing combination products:

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

robes are added artificially to the water, then this procedure will not take much time.

In freshwater retting the fully ripened husks are soaked in pits filled with water along the river banks. Or else put in the net which is submerged in river water by adding some weight to the net that keeps them dipped

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

in the water. This procedure takes about time period of 6 months. Due to advancement in technology, mechanical machines are being used for retting. The unripe coconut husks are dry milled, thereafter crushed in crushing machines. Further they are required to be soaked in water for about 1-2 days only and at

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

last dry milling is done again. In case of ripe husks, they are crushed in crushing machines then undergo the retting procedure for maximum of 10 days.

Defibering process

Defibering is done both manually and mechanically. In manual process the retted husks are hand beaten with wooden hammer that separate

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

s the fiber from the residue. Then are further sorted out by hand. In mechanical procedure, the retted husks are put into steel drums with beaters, these machines operate with the help of motor. The rotating drums with steel spikes further separate the fibers.

The residue is washed and combed manually or m

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

Professional from academic institutions, pharmaceutical industries, health care indust

chanically to obtain mattress fiber. This fiber is then allowed to dry in the sun.

Finishing of the fiber

Both bristle and mattress fibers are compressed by hydraulic press. In case of mattress fibers, they are combed and packed into a bundle of loosely coiled yarns whereas bristle fibers do not require t

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

o be combed. Now these bundles of yarn can be spunned into desired products by the manufacturer.

Its Uses…

Coir is the natural fiber which has no effect of salt water on them. Thus are used for making fish nets and marine ropes. White coir is used is mainly used for making ropes, mats, alternate for mille

.

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

d peat moss. Brown coir is used to for sacks, mattresses, brushes and doormats. Its pads are also useful as erosion control tool and cushioning of the upholstery used by certain automobiles companies.

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

Companies that provide selfless information through particip

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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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