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Saw palmetto, sereano repans, is often known as sabal, especially in Europe but also found under a number of other names. It is a native fan palm of the south east United States of America, especially in Florida. I

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

t was at one time part of the regular diet of the native American Seminole people, even though the taste has been described as repugnant by some. They would collect it, dry it out and use as a year round staple foo

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

Examples of combination products may in

d. It was also used by early settlers as a medicine for cattle with urinary problems and in 1907 a saw palmetto drying facility was set up in Florida by Lilly and Company. It began to be introduced by drug companie

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

s in the 1950s when it was used in the treatment of prostate enlargement. It was especially effective when treating the early stages of the disease and considered to be less likely to cause the patient harm from si

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

e effects than using other drugs. It was later found to help with hair loss problems by limiting 5 Alpha Reductase action and so promoting healthy hair follicles. Now saw palmetto is becoming the herbal treatment o

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

Combination pro

f choice for alopecia androgenica.

Saw palmetto baldness treatment is said to work by interrupting hormonal signals and therefore reducing the uptake by the hair follicles of a damaging chemical called dyhydrotest

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

osterone (DHT). There are both topical and oral preparations and these can complement each other by reducing DHT locally on the scalp and throughout the body so promoting healthy hair growth.

The study most often

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

cited when explaining the benefits of saw palmetto baldness treatment was a trial run in 2002 by the group of scientists Nelson Prager, Karen Bickett, Nita French, and Geno Marcovici*. This was a relatively small s

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

udy conducted under double-blind conditions on 19 men between the ages of 23 and 64 years with mild to moderate hair loss. The trial involved administering a oral daily dosage containing 400mg of liposterolic extra

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

ct of saw palmetto (LESP) with additional [beta]-sitosterol and extra nutrients. Results after five months showed that there was an improvement in hair growth in 60% of the men taking the herbal combination. This c

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

ompared to an 11% improvement of those receiving a placebo. Although the small number of men taking part in the study meant that the results could have occurred by chance the findings were still very encouraging.

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

Following aspects would a

There are now many companies selling saw palmetto baldness treatments and as such there can be problems with difference

dd to the challenges in developing combination products:

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

in recommended dosages. It is a natural product which means that there are variations in the amount of active ingredients that the berries contain. At present there are no regulated manufacturing standards for the

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

purity of saw palmetto and so far the treatment has not yet been evaluated by the US food and Drugs Administration (FDA) for safety. Therefore purity and effectiveness cannot be guaranteed and there can also be wi

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

de variations in the quality and concentration from brand to brand. Customers should therefore only buy from reputable companies and must ensure that the preparation contains the saw palmetto lipid extracts. These

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

are the plants natural active ingredients such as fatty acids, oils, waxes and steroids and these are not contained in the juice, bark or dried berries.

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

Professional from academic institutions, pharmaceutical industries, health care indust

aw palmetto baldness treatments are low in toxicity and now widely used in North America for the treatment hair loss and also used to treat prostate enlargement. Sometimes as an extra step, high concentration s

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

aw palmetto in gel form is applied topically to the scalp for improved results. For the early stages of male pattern baldness saw palmetto seems to offer a relatively safe form of treatment before resorting to pres

.

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

cribed drugs.

One note of caution, although saw palmetto can be used by most people, it has not been proven to be safe for women during pregnancy and lactation.

*Prager N, Bickett R, French N et al. A randomized,

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

Companies that provide selfless information through particip

double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-[alpha]-reductase in the treatment of androgenetic alopecia. J Altern Complement Med 2002; 8(2): 143-152

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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