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Osteoarthritis (OA), the most common type of arthritis, is a chronic condition that afflicts some 21 million Americans. It is characterized by the disintegration of cartilage, the part of

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

the joint that cushions the ends of the bones. This breakdown causes stiffness, pain and loss of movement. Eventually the cartilage can wear away entirely, causing bone to rub on bone. OA g

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

Examples of combination products may in

enerally affects specific joints such as the hips, hands, knees, lower back and neck. Joint pain or stiffness occurs most often after periods of either inactivity or overexertion.

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

steoarthritis Causes Certain factors increase the risk of OA. These include heredity, being overweight, joint injury, repeated overuse of certain joints, lack of physical activity,

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

poor joint alignment, nerve injury and aging. A physical exam, a detailed medical history, and tests such as X-rays and magnetic resonance imaging (MRI) are generally used to diagnose the

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

Combination pro

condition. Maintaining a healthy weight can go a long way toward preventing OA, according to Hayes Wilson, M.D., chief of rheumatology at Piedmont Hospital in Atlanta and national medical

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

dvisor for the Arthritis Foundation. “If you are ten pounds overweight,” says Dr. Wilson, “that’s like burdening your knees with thirty pounds.” A study published in the Annals of Internal

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

Medicine found that in women, losing as few as 11 pounds could cut the risk of OA of the knee by 50 percent.

Osteoarthritis Treatments Corticosteroids can be injected into

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

joints to ease inflammation. A substance called hyaluronic acid, which eases dehydration of the cartilage, can be injected into the knees. Acetaminophen may reduce joint pain. Nonsteroidal

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

anti-inflammatory drugs (NSAIDs) such as ibuprofen may help reduce stiffness and swelling as well as joint pain. Preventive tactics, such as maintaining a healthy weight, can also be benefi

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

cial by easing stress on joints. Although it’s not a cure, acupuncture may ease the pain of OA, says Patience White, M.D., M.A., the chief public health officer of the Arthritis Foundation

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

Following aspects would a

. So can visualization exercises in which arthritis sufferers envision that they are in less pain. Joint replacement is the treatment of choice when a joint is completely destroyed and the

dd to the challenges in developing combination products:

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

e’s significant pain and functional limitation. Part or all of the joint may be replaced, typically with metal or plastic. Within 5 to 10 years, scientists may be able to build new cartilag

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

e to replace what has worn away.

What exercises are best for alleviating osteoarthritis? Stretching and exercises for flexibility are crucial to keeping joints as mobile a

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

s possible, according to Jeny Rund, a physical therapist based in Baltimore. Strengthening exercises, such as working out with weights, can help protect your joints by improving muscle tone

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

Aerobic exercises benefit overall health and fitness and can help keep weight down. Aquatic exercises and walking offer several benefits, says Rund: aerobic conditioning, strength buildin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g and flexibility. And these exercises don’t overstretch the joints.

How can I eat healthfully and keep my weight down? Choose fruits and vegetables in a wide range of col

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

ors to get the most nutrients; keep them in the front part of your fridge so it’s easy to reach for them when you want a snack. Cut down on full-fat cheeses. Rather than eating three square

.

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

a day, try to eat a number of smaller meals throughout the day. Save sweet desserts for special occasions—birthdays and anniversaries, for example. Now that you know the available treatm

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

Companies that provide selfless information through particip

ent options for osteoarthritis, you and your doctor can develop a plan that’s right for you—and you can enjoy life pain-free. --Jean Maguire ©MediZine's Healthy Living, Second Quarter 200

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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