E-Articles - Health and Fitness

Alpha Lipoic Acid, or ALA, can be obtained from the therapeutic market either as a si

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

ngle supplement or in combination products with antioxidants, such as vitamins C 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

. Pharmanex and LifePak are dietary supplements used as anti-aging therapeutic optio

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. It contains ALA, vitamin A, B6, B12, C, D, E, K, thiamin, riboflavin, niacin, fol

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

te, biotin, pantothenic acid, calcium, iodine, magnesium, zinc, selenium, etc as diet

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

Combination pro

ry supplements.

Other brands include Puritan’s Pride (300mg ALA), Rexall Super (200

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

g ALA), Solgar (60mg ALA), Spring Valley (100mg ALA), Sundown Alpha (50mg ALA), and V

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

itamin World (three options breathe with the user 100mg ALA, 200mg ALA, 300mg ALA).

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

or topical application, Reviva Alpha Lipoic Acid Lotion is available as an anti-aging

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

product. Its other potential ingredients include vitamin C, vitamin E, and DMAE bitar

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

rate. The topical product of Dr. Perricone, based on Alpha Lipoic Acid and vitamin C,

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

Following aspects would a

include: N.V. Perricone ALA Nutritive Cleanser (to tone the skin), N.V. Perricone Vit

dd to the challenges in developing combination products:

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

min C Ester Amine Complex Face Lift (lifts the skin and helps treat underlying causes

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

of inelastic skin), N.V. Perricone ALA Eye Area Therapy (to nourish, restore, and pro

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

tect eye), N.V. Perricone ALA Lip Plumper (enhances fullness, contour and color of l

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

ps), N.V. Perricone ALA Evening Facial Emollient (to smooth, renew, and refine the sk

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

Professional from academic institutions, pharmaceutical industries, health care indust

n overnight), and N.V. Perricone Face Finishing Moisturizer (to soothe, hydrate, and

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

rotect skin).

It is clear that, because ALA has so many positive health applications

.

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 is probably one of the most natural ways to go about improving health and physica

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

Companies that provide selfless information through particip

aesthetic. Always consult your doctor before embarking on a new anti-oxidant regimen

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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