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Having originated in Southeast Asia, the whole mangosteen fruit has been revered for its taste, but also for its healing properties. Historically, the whole fruit was used to treat people both topically and internally. This was done by eit

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

her grinding the rind down and applying it directly to the skin or steeping it in water overnight and then drinking the resulting mangosteen tea. It has been used to restore intestinal health for centuries, as well as treat other infection

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

Examples of combination products may in

s. Documented internal and external use:

In the book Fruits of Warm Climates, Dr. Morton calls particular attention to the importance mangosteen rind in traditional preparations. She recorded that the mangosteen rind was sliced, dried, 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.

owdered and then administered. Often times it was first made into an ointment and then applied topically on skin disorders. Additionally, she states “the rind decoction is applied externally as an astringent lotion.” Dr. Morton also makes

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

mention of internal uses of the rind. “A portion of the rind is steeped in water overnight and the infusion given as a remedy.”

On May 26, 1885 The Illustrated London News reported that “Dr Garcin says the mangosteen is the only fruit whi

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

Combination pro

ch sick people are allowed to eat unsparingly; it is given with safety in almost every disorder.”

Modern science is only now beginning to understand and explain why the rind of the mangosteen fruit has been so revered for centuries. Howev

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

er, we know this: to benefit from the complete power and nutritional impact of the mangosteen fruit, it should be consumed just as it has been for more than a thousand years—in its whole fruit form.

As early as 1933, studies were conducte

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

d to compare the whole fruit to single compound extracts taken from the rind. In 1933, Caius and Mhaskar found that the whole fruit offered more than 60% success rates in boosting and restoring intestinal health. In short, consumption of t

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

he whole mangosteen rind delivers benefits far superior to chemical extracts from that same rind. On-going research continues to find valuable properties and several active phytochemicals have already been identified in the fruit, includi

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

ng:

• 39 different xanthones – These powerful phytonutrients demonstrate unique and valuable health properties.

• catechins – The mangosteen rind has been shown to have the same level of this active ingredient as found in green tea.

• p

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

oanthocyanidins – The same benefit touted in grapeseed extract, proanthocyanidins are found in efficacious amounts in the whole mangosteen fruit.

While scientific researchers are still working to demonstrate how these phytochemicals work

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

Following aspects would a

together synergistically, the phytonutrients found in the whole fruit are among the most studied, touted and beneficial in existence today. This much is certain: extracts can never match the incredible spectrum of benefits available in the

dd to the challenges in developing combination products:

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

honored mangosteen fruit.

Dozens of studies demonstrate the incredibly beneficial properties of the mangosteen fruit. Among the most important benefits:

Sustains a healthy cardiovascular system*
• The cardiovascular system (or circ

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

ulatory system) includes the heart, the blood and blood vessels. The importance of maintaining a healthy cardiovascular system cannot be overstated. Because of poor diet and nutrition heart conditions are the number one cause of death and

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

disability in the United States and most European countries.

Supports cartilage and joint function*
• Cartilage is a dense connective tissue found in the joints, the rib cage, the ear and the nose. The knee joint, one of the most com

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

plex in the body, is more likely to be injured than is any other joint.

Strengthens the immune system*
• Inflammation is one of the first responses of the immune system to infection. Symptoms will usually include a redness or swellin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g, both caused by an increase in blood flow.

Promotes a healthy seasonal respiratory system*
• The respiratory tract is a common site for infections. Upper respiratory tract infections are one of the most common infections in the wor

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

ld, accounting for one billion illnesses in the United States annually.

Maintains intestinal health*
• The gastrointestinal tract—consisting of the mouth, pharynx, esophagus, stomach and small and large intestines—is a prominent part

.

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 the immune system. Gastroenteritis is inflammation of the intestines and is the most common disease of the intestines.

Neutralizes free radicals*
• Large molecules with powerful antioxidant properties, like xanthones, may stabili

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

Companies that provide selfless information through particip

ze free radicals. Left uncontrolled, free radicals can damage cells, tissue or DNA. *These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease

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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