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We've all heard about tennis elbow, and many of us have suffered from it. In reality, it is a form of tendonitis brought on by the frequent, repetitive motion

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

s involved in playing tennis. Tendonitis, however, is not limited to the elbow or arm. It can occur throughout the body. Any activity which places stress on

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

Examples of combination products may in

the same tendon can cause that tendon to become inflamed and sore.

Chronic Tendonitis

Tendonitis can be either acute (i.e. a temporary flare up) or c

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

hronic (i.e. long lasting). When tendonitis keeps recurring, it is called chronic tendonitis.

Tendons are composed of elastic-like tissue which connects our

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

muscles to our bones. As we age, tendons tend to lose their elasticity through normal wear and tear. From time to time, a tendon will break or tear and scar

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

Combination pro

tissue forms in the healing process. Scar tissue is not as flexible as tendon tissue and frequently causes pain and inflammation with continued use and motio

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

n. Most often the areas affected are elbows, knees, ankles, shoulders and feet.

Obviously it’s these parts of our anatomy that see repeated use during the co

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

urse of a normal day. As we continue placing strain on an injured tendon, it doesn’t have an opportunity to heal which, in turn, leads to chronic tendonitis.

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

Age is only one of the underlying causes of chronic tendonitis. Athletes who are highly trained and in superb condition can also suffer from chronic tendonit

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

is. Again, it is the repetitive motions required by a variety of sports that cause the condition to erupt. For example, repeated motion of the golfer’s swing

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

or a pitcher’s throwing arm in baseball over the course of time can cause weakness in the tissue and lead to inflammation of the muscles and tendons. This is

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

Following aspects would a

why it’s so important to do stretching exercises and warm ups prior to strenuous activity.

Left untreated, things can only get worse. Both acute and chronic

dd to the challenges in developing combination products:

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

tendonitis sometimes will result in a tear or rupture of the tendon. In this case, the physician will probably prescribe surgery, but only after more conserv

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

ative measures have failed.

Treating Chronic Tendonitis

Acute or chronic tendonitis can cause mild to severe pain. In its simplest and most conservat

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

ive approach, treatment will involve analgesics such as ibuprofen and resting the affected area. Depending on the severity, your physician may conclude that y

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

ou will benefit from an anti-inflammatory medication and may prescribe cortisone injections. This is an effective, and powerful anti-inflammatory medication t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat helps to reduce the pain and swelling and promote healing of tendonitis. Treatment may also include mild stretching exercises in order to keep the joints f

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

lexible.

Just a word of caution is in order. Corticosteroids can be injected but they do not come without risks. One of their side effects is that they can w

.

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

eaken the immune system or infection can appear at the injection site. Again, It is critical that the tendon be given time to heal or more serious tendon injur

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

Companies that provide selfless information through particip

y can occur. And, as mentioned, surgery may be required in cases of tears or ruptures in order to repair the damage and relieve the pain of chronic tendonitis.

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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