Advice Pool - Health and Fitness

Diabetes is often easy to ignore especially in the early stages. The body will appear to work well. But what actually happens is that the excess glucose in the blood keeps eroding the inner lining of the blood vessel threatening major organs like heart, ne

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

rves, eyes and kidneys. Though you may not feel the effects right away, you will eventually feel it.

Compared with people who don’t have diabetes people with diabetes are

Two to four times more likely to die of heart attack

Two to fou

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

Examples of combination products may in

times more likely to have a stroke

Likely to become blind

Likely to suffer kidney failure

Likely to have gangrene of the feet

If the blood glucose is maintained close to normal you can reduce the risks of complic

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

ations. Diabetes can cause both short term and long term complications.
The long term complications of diabetes include

Coronary artery disease

Stroke

Peripheral arterial disease

Nerve Damage (Neuropathy)
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Kidney damage ( Nephropathy)

Eye damage ( Retinopathy)

Increased risk of infection

Coronary artery disease
Coronary artery disease is the leading cause of death in people with diabetes. Diabete

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

Combination pro

s causes narrowing of the blood vessels by a process called atherosclerosis. When the blood vessels to the heart get narrowed down the blood flow is obstructed and it causes chest pain and heart attack. It is usually treated with aspirin, cholesterol lower

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

ng drugs and blood pressure drugs.

Stroke
Stroke is another long term complication of diabetes which occurs when the blood supply to apart of your brain is interrupted or severely reduced and the brain tissue is deprived of oxygen

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

and nutrients. Within a few minutes to few hours, brain cells begin to die. The interruption can be from a clogged or blocked blood vessel (ischemic stroke) or from a leaking or ruptured blood vessel (hemorrhagic stroke). Ischemic stroke is more common.

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

strong>Peripheral arterial disease
With peripheral arterial disease the arteries supplying the limbs, more commonly the legs, becomes clogged or partially blocked due to atherosclerosis. It causes pain, cramping in the legs while walking. T

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

he treatment includes control of cholesterol and high blood pressure and surgery to bypass obstructed vessels.

Nerve damage (Neuropathy)

High levels of blood glucose can damage the delicate nerves. Excess glucose weakens walls of t

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

e tiny blood vessels that nourish the nerves.

Damage to the sensory nerves may leave you unable to perceive pain, warmth, coolness and texture.

Damage of the autonomic nerve can increase the heart rate and in men can interfere with the

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

Following aspects would a

r ability to have erection.

Damage of the motor nerves causes weakness of the muscles.

The symptoms include tingling feeling, numbness, burning pain, stabbing and aching pain, a crawling sensation. It is treated with pain relievers,

dd to the challenges in developing combination products:

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

Capsaicin, acupuncture, biofeedback and relaxation exercises.

Kidney Damage (Nephropathy)
Diabetes damages the filtering system of the kidneys. Up to 30% of the diabetics eventually develop kidney disease called nephropathy. The l

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

nger you have diabetes, the higher your risk of kidney damage. The signs and symptoms of this long term complication of diabetes include

Swelling of the ankles, feet and hands

Shortness of breath

High blood pressure

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

>Poor appetite

Metallic taste

It is treated with drugs called ACE inhibitors, low protein diet, dialysis and in final stages kidney transplant.

Eye Damage (Retinopathy)

High blood glucose affects the tiny blo

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

d vessels in retina of the eye. In fact among the long term complications of diabetes, they are the first to be affected. Almost every one with Type I diabetes and 60% of those with Type II diabetes have some sort of eye damage. The signs and symptoms of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

his long term complication of diabetes include

Tiny specks floating in your vision

Blurred vision

Dark spot in the centre of the vision

Flashes of light

Poor night vision

Blindness

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

ere are two types – non-proliferative which is more common and the proliferative types. The eye damage is treated with laser procedures and surgery.

Increased risk of infections
High blood glucose impairs the immune system putting

.

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

you at a higher risk of infection. Your gums, lungs, skin, feet, bladder and genitals are the common infection sites. The signs and symptoms of this long term complication of diabetes depend on the site of infection.

Gums- redness and bleeding
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
i>
Bladder – frequent urination and burning sensation while passing urine

Vagina- itching

Foot- redness and pus collection

They are usually treated with antibiotics. In severe infection of the foot, debridement is done

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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