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Even arthritis has found its own heroes: glucosamine and chondroitin sulfate. Though the absence of quality scientific tests inhibits these two products from wide acceptanc

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

e in the medical community, glucosamine supplements such as Syn-flex Liquid Glucosamine with a formulation of chondroitin sulfate from shark cartilage, omega fatty acids, an

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

Examples of combination products may in

fundamental vitamins and minerals needed for healthy bones, have been known to not only relieve pain from osteoarthritis in humans, and hip dysplasia in cats and dogs, but

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

have been found to restore and help build stronger cartilages needed for healthy joints.

General Information about Osteoarthritis

Strong cartilage is a key component to ke

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

ping our joints healthy. Healthy joints are essential for our musculoskeletal system to fully function especially in everyday activities that demand a lot of movement or mo

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

Combination pro

tion such as walking, running, or climbing that flight of stairs towards the third storey of a building. Unfortunately, the cartilages in our joints naturally degenerate wi

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

h aging which often results to diminish functionality of the musculoskeletal system particularly in our weight-bearing joints. This condition is generally known as osteoart

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

hritis.

U.S. statistics show that the percentage of OA sufferers have increased significantly since the 90’s, affecting 1 out of every 5 adults. Trailing cardiovascular di

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

eases, it is the second leading cause of immobility among adults over 15 years of age.

The Role of Glucosamine and Chondroitin Sulfate

Glucosamine, scientifically known as

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

glucosamine-6-phosphate, is a natural product (an amino sugar, to be exact) of bodily processes that is produced during the synthesis of glutamine and fructose-6-phosphate.

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

It is a known aid in relieving the effects of osteoarthritis particularly when it comes in the form of UDP-N-acetylglucosamine that facilitates the growth of cartilage elem

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

Following aspects would a

ents such as the proteoglycans (an interwoven collection of fiber and proteins that trap in water in the cartilages) and glucoaminoglycans (carbohydrates essential for the b

dd to the challenges in developing combination products:

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

ilding of connective tissues such as cartilages), both necessary in the formation of healthy joints.

Glucosamine is a dietary supplement which has not been thoroughly teste

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

d and approved by the U.S. Food and Drug Administration but is a fast growing popular source of alternative treatment for osteoarthritis and other forms of arthritis in both

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

humans and animals. Manufactured glucosamine occurring in the forms of glucosamine HCL and glucosamine sulfate are extracted from the shells of crabs, and shellfish. Genera

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

l dosage of glucosamine supplements is given at 1500 mg per day either in pill or liquid form although the latter has been found to be more effective.

Synflex Liquid Glucos

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

Professional from academic institutions, pharmaceutical industries, health care indust

mine combines another known ingredient of healthy joints known as chondroitin sulfate. Chondroitin sulfate, like glucosamine, naturally occurs in the body. When manufactur

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

ed, it is usually extracted from shark cartilages (as used in Synflex Liquid Glucosamine) and serves as water and mineral-binding molecules that usher water and minerals int

.

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

the cartilages replenishing and lubricating dried-up and deteriorating cartilages in the body joints. Apart from this initial function, chondroitin sulfate also blocks des

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

Companies that provide selfless information through particip

tructive enzymes that hasten cartilage degeneration.

Syn-flex 1500 contains white willow bark, an anti-inflammatory substance which aids in pain relief experienced by users

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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