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FROZEN SHOULDER

Frozen shoulder is the name given to a stiff and painful shoulder joint which follows a typical pattern. It is also known as capsulitis or tr

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

aumatic arthritis. The patient is usually aged 45 or over and a frozen shoulder most often occurs on the non-dominant side i.e. the left handed patient will have a right froze

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

Examples of combination products may in

n shoulder and visa versa. A frozen shoulder may follow minor injury such as a fall or even banging into a doorframe or slamming a car door awkwardly. The pain only comes on a

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

week or so after the incident when the pain can radiate down the arm to the wrist. The pain gradually increases at first then recedes up the arm into the shoulder joint over

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

the next 4 months. The patient almost always describes the pain as being in the muscle of the shoulder, that is the bulk of the shoulder that gives it its shape. After about a

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

Combination pro

month the arm is painful even at rest and the patient has difficulty lying on the bad side at night. The joint becomes progressively stiffer and more painful at first then th

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

e pain eases and the shoulder remains very stiff. Left untreated the shoulder will not regain full range of movement inside 12 to 18 months.

Pain and stiffness mean a curtail

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

ment of normal activities. Taking the hand behind the back to do up a bra or a zip is difficult and the patient often finds combing their hair painful. Tucking a shirt in or r

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

eaching into a back pocket is also usually difficult and painful. The unusual thing about frozen shoulder is that the capsular pattern of limitation of movement is the same in

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

every patient. So all patients still have some movement out to the side or up in front but are almost unable to get their hand behind their back or up behind their head.

The

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

shoulder like most joints in the body has two surfaces of bone that are lined with cartilage. These surfaces are kept lubricated with fluid which is held around the joint in

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

Following aspects would a

a capsule. This capsule is rather like a thick plastic bag which attaches to the edges of the bony surfaces and is lax enough to allow movement. In a frozen shoulder the capsu

dd to the challenges in developing combination products:

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

le itself becomes inflamed and swollen restricting the movement at the shoulder joint. It is never a good idea to push a joint into pain. If you continue to aggravate the caps

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

ule whilst it is swollen and inflamed then the movement will only serve to increase the swelling, increase the pain and reduce the range of movement still further.

A

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

GOOD RULE OF THUMB IS 'IF IT HURTS DON'T DO IT.' Unfortunately because the onset of frozen shoulder is gradual most people take almost 3 months to realise that the pa

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

in in their shoulder isn't getting any better! If a patient has pain in the shoulder joint lasting for more than a few days it is important to seek professional advice rather

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

Professional from academic institutions, pharmaceutical industries, health care indust

than waiting to see 'if it goes away'. The sooner treatment is commenced the less likely the inflammation is to take hold.

TREATMENT

Treatment with Manual L

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

ymph Drainage and Connective Tissue Manipulation aims to release the tension in the connective tissue around the shoulder which improves the circulation and reduces the inflam

.

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

mation in the capsule allowing the body to accelerate the healing process. The pain is reduced and the stiffness improves. The patient is therefore able to regain full movemen

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

Companies that provide selfless information through particip

t and return to normal activities.

http://www.londonphysiocentre.co.uk/frozen-shoulder.htm

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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