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Anti-inflammatory medications are, without a doubt, one of the biggest selling medication classifications in the Western world. According to the June 17, 1999 issue of the New England Journal of Medicine, doctors wrote more than

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

70 million prescriptions for Non-Steroidal Anti-Inflammatory Drugs or “NSAIDs.” On top of that, more than 30 billion over-the-counter NSAID tablets (aspirin, Tylenol, Advil, etc.) were sold in the United States in that year. But

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

Examples of combination products may in

while these medications offer temporary relief for our everyday aches and pains, what exactly is their function? Are they healing or are they masking beneficial symptoms? Are their better alternatives? The answers to these questi

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

ons may surprise you.

Inflammation can be a normal process designed to heal the body. Inflammation begins with the release of a fatty acid called arachidonic acid. Triggers for arachidonic acid release include chemical or enviro

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

mental toxin exposure, bacterial or viral infection, or injury and trauma. Once released, arachidonic acid is converted to compounds called prostaglandins, specifically one called PGE2 which brings about the signs and symptoms o

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

Combination pro

inflammation: redness, heat, swelling, and pain. Each of these symptoms, while uncomfortable, is a sign that the body is repairing itself and protecting itself from further injury.

NSAIDs and other anti-inflammatory medication

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

s stop the conversion of arachadonic acid to prostaglandins at various locations in the pathway. They can also have side effects on the body which include ulcers, intestinal bleeding, liver damage, kidney failure, headache, and

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

ore. Remember that the symptoms of inflammation indicate an attempt of the body to heal by increasing its metabolic processes. By suppressing the symptoms of inflammation, healing never actually occurs, the body can remain infla

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

ed, and the cycle will begin again.

So how can we support the inflammation process, but reduce the symptoms that are so uncomfortable? One answer lies with essential fatty acids. Essential fatty acids or EFAs are fats that come

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

directly from our diet or from supplementation. They are called essential because our body cannot make them on its own and we must provide them through the diet. The most beneficial EFAs are the Omega 3 and Omega 6 fatty acids.

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

he Omega 3 fatty acids are extremely powerful. In the body’s constant search for balance, it directly synthesizes an anti-inflammatory prostaglandin called PGE3 from Omega-3 fatty acids. Adequate amounts of PGE3 inhibit the infl

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

Following aspects would a

mmatory process and ensure that inflammation does not overwhelm the individual. In other words, omega-3 fatty acids decrease inflammation and bring balance to the body. This balance brings allows the body to heal and lessens unc

dd to the challenges in developing combination products:

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

omfortable inflammatory symptoms.

The best source of omega-3 fatty acids is cold-water fish like salmon, trout, halibut, sardines, and cod. These fish are rich in the omega-3 fatty acids. Another very beneficial source of EFAs

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

s marine phytoplankton. Marine phytoplankton are microscopic single-celled plants which provide high levels of vitamins, minerals, and EFAs. They are the beginning of the food chain, the food for whales, and a great source of fo

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

ndational nutrition. Marine phytoplankton is finally available for human supplementation and appears very promising at supporting optimal health. As with any nutritional supplement, finding a good product is very important. Know

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

ing your source will ensure that you have a properly prepared and formulated product that will work effectively. Sources we have found to be reputable and beneficial can be found here.

Balancing the inflammatory response with om

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

Professional from academic institutions, pharmaceutical industries, health care indust

ga-3 fatty acids is not typically done as a quick fix for an acute inflammatory response. For example, fish oils will not provide immediate relief for sports injuries, headaches, etc. Ice, hydrotherapy, homeopathy, and herbs are

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

more effective in those situations. Instead, omega-3 fatty acids are most beneficial in supporting chronic inflammatory conditions like heart disease, diabetes, asthma, arthritis, eczema, colitis, and autoimmune conditions

Essen

.

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

tial fatty acids play a key role in balancing the inflammatory response in the body. They do not suppress healing, but instead support the body’s own anti-inflammatory response. Doing this ensures that healing occurs effectivel

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

Companies that provide selfless information through particip

and efficiently. So the next time you reach for that bottle of aspirin for your chronic pain, remember the marine phytoplankton and the friendly fish and their oils. They may be what you need to live pain and inflammation free

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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