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Sometimes, even if a person lives a healthy lifestyle, abstains from alcohol or drinks it modestly, they can experience a condition that mirrors gout, but is in actuality, a different arthriti

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

c condition altogether known as pseudogout. To help you understand the differences between these two, the following is a breakdown of the causes, symptoms and treatments for each condition.

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

Examples of combination products may in

out

Gout is a form of arthritis that occurs suddenly, usually affecting the big toe, and causes severe painful attacks, tenderness and redness in the affected joint. An attack can last days o

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

weeks. Gout is caused by a build up of uric acid which turns into uric acid crystals that are deposited into the joints causing them to become inflamed. The first attack of gout often occur

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

late at night.

A build up of uric acid that develops into gout can result from:

•High alcohol consumption

•Eating excessive food rich in purines such as organ meats

•Crash diets

•Joint i

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

Combination pro

jury

•Surgery

•Chemotherapy

The symptoms of gout include:

•Sudden intense joint pain

•Inflammation and redness in the affected joint.

•Swelling

•Difficulty moving affected joint within

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

its normal capacity.

Treatment for gout includes:

•NSAIDs - The most common treatment for gout includes nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin and napr

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

xen. They are used to help alleviate paint and reduce inflammation

•Colchicine – prescription med that prevents gout attacks from recurring

•Diet – By controlling what you eat, staying well

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

hydrated and exercising regularly, you can help reduce your uric acid levels and prevent gout.

•Surgery – This is very rare treatment and is only required if there is significant joint damage

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

from frequent attacks.

Pseudogout

Pseudogout is a form of arthritis that occurs when calcium pyrophosphate crystals accumulate in joints. Although it is sometimes referred to as calcium pyr

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

phosphate dihydrate deposition disease (CPDD), the disease is called pseudogout due to the fact that its symptoms and crystal build up are similar to gout.

Like gout, pseudogout causes a sudd

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

Following aspects would a

en extreme attack of pain and swelling to specific joints, which can last for days or weeks. However, unlike gout that usually attacks the big toe first, pseudogout is usually present in the

dd to the challenges in developing combination products:

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

nees, but can also affect the shoulder, elbows, wrists, hands, or ankles. Furthermore, pseudogout can become a chronic arthritic condition that feels more like osteoarthritis or rheumatoid ar

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

hritis.

It is clear that the development of calcium pyrophosphate crystals is what causes Pseudogout. Eventually, crystals can be deposited into the cartilage of a joint and then begin to da

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

age it, a condition known as chondrocalcinosis. Although medical researchers are not sure why the calcium pyrophosphate crystals occur, it is suspected that the condition may be hereditary or

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

related to:

•Hypothryroidism (underactive thyroid)

•Hemochromatosis (too much iron storage)

•Overactive parathyroid gland

•Low levels of magnesium in the blood

•Hypercalcemia (too much ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

lcium in the blood)

•Joint injury

•Surgery (either related to a joint or not)

Unlike gout, pseudogout is not necessarily gender specific or diet related, and usually affects 3% of people in

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

their sixties and approximately 50% of those in their nineties.

The symptoms of pseudogout include:

•Swelling of the affected joint

•Severe pain

•Warmth

•Redness

Treatment for pseudogout

.

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

includes:

•NSAIDs

•Cortisone injections

•Ice therapy, mild exercise and rest

•Surgery – only occurs if severe damage has been done to the joints.

As you can see, both gout and pseudogout

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

Companies that provide selfless information through particip

re incredibly painful conditions that result from the build up of crystal deposits in the joints causing inflammation. Essentially, the main difference between the two is the type of crystals

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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