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I can remember as a young boy that my grandmother always had an Aloe Vera plant in our home. While playing with the neighbors’ kids, I always seem to

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

end the day with plenty of scrapes and minor cuts. Grandma would break off a leaf from her Aloe Vera plant and come to my rescue. Spread over the aff

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

Examples of combination products may in

ected area, the soothing and cooling effect of the leaf’s gel is still fresh in my mind. My mother was also quick to apply the gel to the frequent bur

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

ns she received while cooking. Although many of the remedies that our grandparents would recommend and use originated out of superstition rather than

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

practical application, I don’t think that even grandma knew the true magnitude of healing that lies within the leaves of the Aloe Vera plant.

The heal

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

Combination pro

ing power of the aloe plant is not just a recent discovery. Documents thousands of years old reveal that many cultures; from the ancient Egyptians, Gr

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

eeks and Romans, to the Indian and Chinese people, referenced the use of Aloe Vera for both medicinal and beauty applications. Historic physicians, Pli

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

ny the Elder, Dioscorides and Galen, the father of modern medicine, all used Aloe Vera as a healing remedy. Cleopatra and Nefertiti, Egyptian Queens n

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

oted for their extraordinary beauty, even gave tribute to Aloe Vera as an important part of their beauty regiment. Yes, even our ancestors recognized

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

the benefits of the Aloe Vera plant. In 333 BC, his mentor, Aristotle, supposedly persuaded Alexander the Great to capture the Island of Socotra for i

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

s famed Aloe supplies much needed to treat his wounded soldiers.

Very few remedies are as versatile as Aloe Vera. Taken as a drink it can be used to

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

Following aspects would a

treat internal ailments; applied to the skin it can be used to treat external ailments. Clinical studies show that the aloe plant, often referred to a

dd to the challenges in developing combination products:

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

s the Medicine Plant, speeds healing of damaged skin, fights infections, minimizes scarring, reduces pain, retards aging and moisturizes and retains mo

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

isture by carrying added emollients deep into the layers of the skin. Digestive tract ailments such as irritable bowel syndrome (IBS) and colitis are

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

other areas where Aloe Vera’s natural healing and detoxifying power works to bring relief.

I caution consumers always to look for the seal of the Inte

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

rnational Aloe Science Council when purchasing products boasting of Aloe Vera content. Many products claiming to contain Aloe Vera may have little, if

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

Professional from academic institutions, pharmaceutical industries, health care indust

any, Aloe Vera in their ingredients. Since it is the concentration of Aloe in the product that makes it effective, trace amounts serve only to justif

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

y a producer labeling its product as “Contains Aloe Vera.” The International Aloe Science Council, a Texas based organization, provides certification

.

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 products as containing genuine Aloe. This organization validates the claims of producers as to the quality and quantity of Aloe Vera content in the

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

Companies that provide selfless information through particip

ir products. Perhaps the greatest attribute of Aloe Vera is that there are no known side effects from its use, as is the case with most other remedies

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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