Advice You - Business

Introduction

Usually people consider textile fabrics as the common categorization such as woven, knitted, braided or tufted c

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

onstructions. They commonly abandon nonwoven fabrics form the textile group. In the conventional fabric, the fibre is first ma

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

Examples of combination products may in

e into yarns; on the other hand, nonwovens are manufactured sheets or webs directionally or randomly orientated fibres, bonded

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

through resistance, solidity or sticking together into a fabric.

The demands for fabrics have increased sharply. Conventional

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

textiles are not able to meet the production cost and higher cost of upgradation along with demanding consumers in new fields

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

Combination pro

f consumption. With better customization of characteristics into the fabric and appropriateness to certain end uses being adva

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

tages, nonwovens have emerged rapidly as the fabrics of the future.

Nonwoven fabrics presents many advantages over convention

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

l fabrics, the clearest benefit is cost savings. In recent couple of years the nonwoven industry has emerged at a rapid speed,

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

offering a huge range of products to several diversified fields. Conversely, nonwoven fabrics hold some natural characteristic

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

, which led them to be counted for non-usable in certain applications. At present, many research and development has been cond

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

cted on enhancing the characteristics of nonwoven fabrics. Nonwovens are also entering into some astonishing fields, with maki

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

Following aspects would a

ng its mark in fashion apparel also.

Currently, three fibers lead the worldwide market:

Polypropylene (synthetic – 63 percen

dd to the challenges in developing combination products:

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

)

Polyester (synthetic – 23 percent)

Cellulosic staple fiber (natural-based 8 percent)

Manufacturing Process

To manufactur

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

a nonwoven fabric, first a web is made, and then it is tied (bonded together) to give strength. Usually, Nonwoven fabrics are

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

made from two processes, a one-step or two-step.

One-step process: In this process, the formation of web and bonding is condu

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

ted continuously. The processes, spunbond and melt blown are considered under one-step.

Spunbond process: The thermoplastic f

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

Professional from academic institutions, pharmaceutical industries, health care indust

bers are extruded via a spinneret, and then is it spread on a conveyor belt to make a web. Following the process, the web is b

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

nded by passing it through two calendar rollers.

Melt blown process: The thermoplastic fibers are driven onto a collector scr

.

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

en to make a web. The combination of fibers fixing and snaring, results bonding.

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

Companies that provide selfless information through particip

on.com/industry-article/textile-industry-articles/nonwoven-fabric/nonwoven-fabric1.asp">View Full Article

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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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