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The South African Research Institute, CSIR, started a study on Hoodia Gordonii, a succulent growing wild in the

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

Kalahari Desert. This plant has a reputation amongst the San tribe as a hunger suppressant. They chew this plant

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

Examples of combination products may in

during their long hunting expeditions to prevent hunger. CSIR isolated the active molecule, named it P 57 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.

atented it in 1997. They sold the rights to a British company, Phytopharm, in 1998 to test and market the produc

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

.

In a double blind test, conducted by Phytopharm, 400 mg per day of Hoodia Gordonii powder, for 15 days, reduc

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

Combination pro

ed the calorie intake by 1,000 compared to the control group. Capsules, pills, tincture and diet gum all followe

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

d. This obviously includes genuine as well fly-by-night operators. The only thing that they could not do is to c

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

aim that their product is an aid for weight loss. That would be a patent violation. So they market it as a food

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

supplement.

Phytopharm teamed with Pfizer of USA, a pharmaceutical MNC, to produce P 57 synthetically and marke

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

t the same. But in 2004 Pfizer withdrew from the agreement, as it was not economically viable.

One of the compa

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

ies marketing the Hoodia capsule is ‘Pure Hoodia’, with a registered trademark. They claim that each capsule con

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

Following aspects would a

tains 400 mg of Pure Hoodia Gordonii, imported legally from South Africa, grown in privately owned farms. The re

dd to the challenges in developing combination products:

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

commended dose is 1-2 capsules an hour before each meal. They make no claim that it is a drug, but say that it i

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

s an all-natural dietary supplement.

Truth Publishing, a website for independent consumer guidance, came out wi

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

h a strong accusation against Pure Hoodia. They claim that tests done on Pure Hoodia by “Alkanist pharmaceutica

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

ls,” could not confirm the identity of Hoodia Gordoni. Pure Hoodia capsules do not have 400mg of powder, as clai

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

Professional from academic institutions, pharmaceutical industries, health care indust

med by the company, but less. Truth Publishing alleges that the same company also sells products under the brand

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

names ‘Hoodini’ and ‘Slimtron’.

In view of the facts that Pfizer gave up the attempt for synthetic P 57 in 2004

.

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

, it takes 5-7 years for the plant to mature, there is a limited amount of wild Hoodia in the Kalahari Desert an

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

Companies that provide selfless information through particip

d the trade in Hoodia is restricted by CITES, the guiding factor in Hoodia purchases should be “consumer beware.

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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