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The Vitamin B Complex comprises of the essential B Vitamins - Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin B12 plus 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

vitamins Biotin, Choline and Inositol. Vitamin B Complex is needed for the proper functioning of almost every process in the body. Here are my 5 top re

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

Examples of combination products may in

sons you need to get plenty of B Complex vitamins in your diet.

1. Energy Production

Vitamin B1 is needed to help convert the carbohydrates we ea

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

into glucose. The following B Vitamins are needed at a cellular level to convert glucose into energy - Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6

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

and Biotin. A Vitamin B deficiency in any of these vitamins can lead to decreased energy production, lethargy and fatigue.

2. Healthy Nervous system

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

Combination pro

u>

The Vitamin B Complex is essential for the healthy functioning of the nervous system. Vitamin B5 is needed for the correct functioning of the adrenal

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

lands and the production of some hormones and nerve regulating substances. Vitamin B1, Vitamin B6 and Vitamin B12 are essential for the regulation and cor

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

ect functioning of the entire nervous system including brain function. Vitamin B9 is essential to prevent neural tube defects to the foetus during pregnan

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

y. A deficiency in any of the Vitamin B Complex vitamins can lead to feeling stressed, anxious and depressed.

3. Good Digestion

The Vitamin B Com

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

plex is essential for correct digestion, production of HCl (Hydrochloric acid) and to assist in the breakdown of fats, proteins and carbohydrates. Especia

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

ly vital for good digestion are Vitamin B1, Vitamin B2, Vitamin B3 and Vitamin B6. A deficiency in any of these B Vitamins can lead to impaired digestion

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

Following aspects would a

nd deficiency of essential nutrients.

4.Healthy Skin, Hair and Nails

The Vitamin B Complex is essential for correct RNA and DNA synthesis and cel

dd to the challenges in developing combination products:

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

reproduction. As our Skin, Hair and Nails are constantly growing and renewing themselves we need the following B vitamins to ensure the good health of th

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

ese structures – Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B9, Vitamin B12, Biotin and Choline. Deficiencies of any of these B Vitamins can

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

ead to dry, grey skin, dermatitis, wrinkles, acne, rashes, falling hair and weak, splitting nails.

5. Synergy

The B Vitamins work so closely with

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

one other that a deficiency in any one B Vitamin can lead to poor functioning of any or all of the others even if they are in good supply. Always take the

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

Professional from academic institutions, pharmaceutical industries, health care indust

B Vitamins in a Complex and then top up with any individual Vitamin B, if needed.

B Vitamins are water-soluble which means any excess wil

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

l be excreted through the urine. This also means that B Vitamins need to be taken on a daily basis, as the only one we can store is Vitamin B12. Taking a

.

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

igh dose Vitamin B Complex (50mg – 100mg) daily can turn urine a bright fluorescent, this is perfectly safe and normal so don’t be alarmed!

Thank you for

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

Companies that provide selfless information through particip

taking your time to read this article on the benefits of the Vitamin B Complex to your health. Here’s to your good health………naturally!

Nadine Masseron N

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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