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Polyester Filament Yarn has been on of the good textile products in greater demand due to its tensile capacity. Many products r

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

ight from fabrics to hosiery and also some home textiles products.

Let me first begin with the manufacturing of filament yarn

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

Examples of combination products may in

nd then polyester which are amalgamated by a process. Partially oriented tow or partially oriented yarn is made by winding the

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

ilament-receiving cylinder winds at a speed slightly higher than the speed of extrusion. Filaments from a large number of spinn

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

ng positions are collected to form tow, which can later be cut into staple. If the fiber is to be used as continuous filament y

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

Combination pro

rn, the filaments are wound onto metal cylinders, paper tubes, or bobbins. The diameter, or fineness, of spun yarn, filament ya

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

n, or monofilament is designated by the term denier, which is the weight in grams of 9,000 meters of yarn or filament. Yarns fo

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

r apparel and home furnishings usually have deniers ranging from 80 to 160.

Polyester fiber spinning and drawing equipment can

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

usually be used to produce other melt-spun fibers such as nylon 6 and nylon 66, with relatively minor modification. Waste polye

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

ter polymer or fiber is sold, reprocessed, burned, or buried, depending largely on the purity. Some of the leading licensors of

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

polyester fiber technology are Zimmer, DuPont/Chemtex, Inventa, Karl-Fischer, and NOY. Polyester fibers are produced by extrudi

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

Following aspects would a

g molten polyethylene terephthalate (PET) through a metal plate or thimble with fine holes called a spinnerette ("spinning"). N

dd to the challenges in developing combination products:

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

xt, the fibers are drawn to further orient the polymer molecules, and to adjust the tensile strength, elongation, modulus, dyea

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

ility, and other physical properties of the fiber. The fibers are further processed by draw-twisting, draw-texturizing, spin-dr

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

awing, crimping, coiling, and looping.

China, USA and West Europe have been major polyester importing countries in the last 3

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

ears. On an average China imported close to 950 thousand tons of polyester in the last 3 years (2002-2004), which was about 10%

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

Professional from academic institutions, pharmaceutical industries, health care indust

of China annual consumption. Similarly, USA and West Europe imported around 500-600 thousand tons, which met 30% and 40% of the

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

r consumption respectively. Among exporters, Taiwan and Korea are large polyester exporters with close to 700-900 thousand tons

.

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 exports in last three years. To a smaller extent, Malaysia, Thailand and Indonesia exported about 200-300 thousand tons of p

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

Companies that provide selfless information through particip

lyester a year in the last three years. USA too has exported around 700 thousand tons of polyester per annum during 2002 – 2006

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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