E-Articles - Health and Fitness

St. John's wort has been traditionally used to treat mental disorders as well as nerve pain for centuries. It is also curren

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

tly acknowledged by herbalists as a sedative and an effective treatment for malaria as well as a balm for wounds, burns, and

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

Examples of combination products may in

insect bites.

St. John's wort is currently used to treat mild to moderate depression, anxiety, and sleep disorders. It has

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

been shown to be more effective than antidepressants generally prescribed for mild to moderate depression.

In some enlighte

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

ed countries like Germany, the sale of St John's Wort has outstripped many of the major prescription anti-depressants

There

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

Combination pro

have been several dozen studies looking at the effectiveness of St. John's Wort. The British Medical Journal recently condu

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

ted a study of 23 randomized trials involving over 1,700 patients. The patients had mild to moderate depression. St. John's

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

wort was just as effective as standard antidepressants. However, none of the studies exceeded 12 weeks in duration making th

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

m less than ideal. Fifty percent of patients taking St. John's wort improved with respect to their depression as opposed to

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

only 23 percent of patients that were taking placebo.

More recently, there have been a number of clinical studies that have

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

demonstrated that standardized extracts of Hypericum are more effective than a placebo in the treatment of depression. Activ

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

Following aspects would a

e ingredients include glycosides, flavonoids, volatile oils, tannins and resins. The active ingredients in Hypericum are tho

dd to the challenges in developing combination products:

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

ght to boost serotonin levels, which are usually lacking in depressed people. In several studies, St. John's wort was more e

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

ffective than standard antidepressants for mild to moderate depression.

St. John's Wort has been known to interfere with ce

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

tain medications. If you are taking any medications or under doctors care consult your physician before taking.

For example

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

tricyclic antidepressants may interact with St. John's wort.

St. John's wort can also increase the effects of prescription

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

Professional from academic institutions, pharmaceutical industries, health care indust

drugs used to treat depression. It can also interfere with drugs used to treat HIV infection, to treat cancer, for birth con

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

trol, or to prevent the body from rejecting transplanted organs.

Pregnant or nursing woman or children under 12 should not

.

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

ake supplements containing St John's Wort Also, persons taking medications such as cyclosporin which are usually prescribed

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

Companies that provide selfless information through particip

in serious auto-immune problems, organ transplantation to stop rejection or cancer therapy should also avoid St. John's Wort

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-article.org.ua/article/239023/e-article-St-Johns-Wort--An-Herb-For-Depression-And-Insomnia.html">St. John's Wort - An Herb For Depression And Insomnia</a>

BB link (for phorums):
[url=http://www.e-article.org.ua/article/239023/e-article-St-Johns-Wort--An-Herb-For-Depression-And-Insomnia.html]St. John's Wort - An Herb For Depression And Insomnia[/url]

Why haven't you built your website yet? Too expensive? Too complicated? Too time-consuming? Here are some tips on how to create it (cheaply) in a weekend.

There are things about your life and health insurance premium you can't change. Leave them that way because you can't do anything about them. However, there are a lot of things you can do to lower your premium. Here they are...

Tags

Links

E-Articles - St. John's Wort - An Herb For Depression And Insomnia

Related Articles: