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At the base of the palm bounded by bones and ligaments, the carpal tunnel is a narrow passageway about as big around as your thumb. The median nerve passes through this tunnel along with 9 tendons. Carpal Tunnel Syndro

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

me (CTS) occurs when the median nerve becomes compressed or squeezed at the wrist causing pain, weakness or numbness and tingling in the hand and wrist which can radiate up the arm. Symptoms usually develop gradually 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

may become worse at night. Symptoms often follow a pattern of improving with rest then worsening with activity that require grasping items or bending the wrist.

What causes Carpal Tunnel Syndrome?

Pressure on the Med

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

an nerve can be caused by trauma or injury to the wrist, frequent use of vibrating hand tools or any repetitive, forceful motion with the wrist in a bent position especially when done for prolonged periods without rest.

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

CTS can also be caused by underlying medical conditions including rheumatoid arthritis, osteoarthritis, diabetes, pregnancy and thyroid problems. Symptoms of CTS usually resolve or improve when these underlying medical

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

Combination pro

onditions are treated.

Non-surgical Treatment for Carpal Tunnel Syndrome

Treatment for CTS focuses on decreasing demands on the wrist and hand and reducing pressure on the median nerve. This is usually accomplished by

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

activity modification, splinting, exercise and anti-inflammatory measures which may include ultrasound, iontophoresis, cold packs and oral medication. Non-surgical treatment is most effective with mild to moderate symp

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

oms of CTS.

Activity Modification

Wrist position is key to controlling carpal tunnel symptoms. The carpal tunnel is most narrow when the wrist is bent down or extended all the way back and largest when the wrist is st

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

aight. The more the wrist is bent, the more pressure is placed on the median nerve. Changing how you do repetitive hand activities or avoiding these activities all together can help. Principles of activity modificatio

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

to follow:

• Avoid flexed finger/flexed wrist postures.
• Take frequent breaks (every 30-60 minutes) from repetitive hand activity.
• Avoid repetitive, forceful grasp and prehension activities.
• R

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

lax your grip. Avoid grasping too hard when driving, writing or using hand tools.
• Alternate activity frequently.
• Wear padded gloves when working with vibrating equipment.
• Use correct posture.

Wris

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

Following aspects would a

t Splints (braces)

Splints are used to immobilize the wrist in a neutral (unbent) position to maximize the size of the carpal tunnel and reduce pressure on the median nerve. Splints are worn during the night. Usually

dd to the challenges in developing combination products:

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

t isn’t necessary to wear splints during the day. Doing so may actually worsen the problem because it makes work more awkward.

Physical Therapy and Exercise

Anti-inflammatory modalities of iontophoresis, ultrasound an

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

cold packs and special hand exercises can help to relieve mild to moderate symptoms of CTS.

Arm & Shoulder Stretch

Lace fingers together & turn palms facing out as you press your hands away from your body until a stre

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

ch is felt. Hold 10 seconds, Repeat 3-5 times

Cervical Forward Bending

Bend head forward until a stretch is felt. Hold 10 seconds, Repeat 3-5 times.

Wrist Flexor Stretch

Keeping elbow straight, grasp involved hand

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

and slowly bring wrist back until a stretch is felt. Hold 10 seconds, Repeat 3-5 times.

Executive Stretch

Lace fingers together behind your head, bringing your elbows back as far as possible. Squeeze your shoulder bl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ades together. Hold 10 seconds, Repeat 3-5 times.

Cervical Side Bending

Tilt head toward shoulder until stretch is felt. Hold 10 seconds, Repeat to opposite shoulder, Repeat 3-5 times.

Wrist Extensor Stretch

Keepin

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

elbow straight, grasp involved hand and slowly bend wrist down until a stretch is felt. Hold 10 seconds, Repeat 3-5 times.

Posterior Shoulder Stretch

Grasp your elbow with other hand as shown. Pull the elbow and arm

.

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

across your chest so that you feel a stretch. Hold 10 seconds. Repeat 3-5 times.

Cervical Rotation

Turn head to look over shoulder until a stretch is felt. Hold 10 seconds. Repeat to opposite shoulder. Repeat 3-5 t

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

Companies that provide selfless information through particip

mes.

Strengthening exercises for affected muscles and reconditioning of the arms are begun as symptoms resolve. See your physician or an Excel physical therapist if you are experiencing symptoms of CTS. www.ExcelPT.co

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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