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Phthalates, a class of chemicals used in the manufacture of plastic food packaging and linked to reproductive health issues, was recently implicated in causing abdominal obesity and insulin re

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

sistance in adult males. The study, recently published in the online edition of the journal Environmental Health Perspectives, was conducted by the University of Rochester Medical Center.

The

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

Examples of combination products may in

research adds to the growing body of scientific evidence linking phthalates to health problems in humans. Previous scientific research involving humans showed a link between phthalates and p

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

oor semen quality in men and subtle changes in the reproductive organs of baby boys. It was this connection between phthalates and testosterone that helped to establish a basis for the Univer

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

sity of Rochester study, according to Dr. Richard Stahlhut, the lead author.

"Substantial declines in testosterone level and sperm quality have been observes in the United States and other co

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

Combination pro

untries over the last several decades, which urgently require explanation," Stahlhut said. "While we can’t say yet that phthalates are a definite cause, I am certain that they are on the list

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

of chemicals that demand careful study."

The research team hypothesized that since low testosterone appears to cause increased belly fat and pre-diabetes in men, then phthalates might have a

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

direct link to obesity.

They analyzed urine, blood samples and other data from the National Health and Nutrition Examination Survey (NHANES), a large, multi-ethnic, cross-section sampling of

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

Americans. This data is collected routinely by the Centers for Disease Control and Prevention.

The researchers reviewed data from 199 to 2002, the most recent years that figures on phthala

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

tes levels are available. The NHANES studied data on phthalate exposure for 1,451 adult men, including obesity and waist circumference. For 651 of the men in the study, data was collected on

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

fasting glucose and insulin levels, which are used to calculate insulin resistance.

The study showed that more than 75 percent of the U.S. population has measurable levels of several phthalat

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

Following aspects would a

es in their urine. “Unfortunately, there’s still a lot to learn about phthalates,” Stahlhut said. “The difficult issue is what combinations of common low-dose chemical exposures might be con

dd to the challenges in developing combination products:

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

tributing to these problems.”

Consumer reaction and the resulting regulation which should result from studies like these should force consumer products manufacturers and food packagers to sea

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

rch for alternatives. The phthalates compounds are used most frequently as softeners and plasticizers for products made with polyvinyl chloride (PVC), such as plastics, which are used in a va

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

riety of consumer and personal care products including food packaging materials, toys, and medical/pharmaceutical devices and drugs. The most commonly used phthalate is DEHP. Food contaminat

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

ion occurs when plastic food packaging materials are made from PVC that was treated with phthalates.

Phthalates are also used in the manufacture of cosmetics, shampoos, soaps, lotions, lubric

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

Professional from academic institutions, pharmaceutical industries, health care indust

ants, paints, floor tiles, and pesticides. One kind of phthalate is used in making perfumes and lotions, shampoos, make-up, nail polish and hairsprays.

In Europe, products containing phthalat

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

e chemical compounds are regularly evaluated and in 2005 six phthalate softeners used in PVC toys and childcare products that children place in their mouths were banned.

The U.S. Food and Dru

.

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

g Administration has done nothing to-date to regulate the use of phthalates despite calls for action by several consumer watchdog groups. California is the first state to attempt to regulate

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

Companies that provide selfless information through particip

products containing this chemical. However, legislation to ban phthalate chemicals from children’s toys, teething devices, and other childcare products was rejected by the California Assembly

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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