Advice Pool - Health and Fitness

An insulin pump is a relatively new advancement in the way to administer insulin into the body as a means to regulate the levels of glucose in

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 blood. People that have diabetes often have to inject insulin into the body via a syringe. This can be painful and sometimes inconvenient t

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

Examples of combination products may in

do so an insulin pump is a useful alternative. This article will discuss how insulin pumps work and some of the advantages and disadvantages.

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 insulin pump consists of :

a pump

a disposable reservoir of insulin

an infusion set - tubing and a cannula that connects the insulin res

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

rvoir to the body

The reservoir of insulin is fitted into the pump. The pump is about the size of a cell phone and can be worn around the wais

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

Combination pro

in a pouch or any other way that you find suitable. The pump is connected to a cannula via a thin tube. The tube passes insulin to the cannula

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

that is attached to the skin. In this way insulin is passed into the body.

Insulin pumps pass insulin into the body in two ways. The first is

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

a continuous passing of insulin into the body. This is used to maintain the level of glucose in between meals, exercise or at night. It is call

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

d the basal dosage.

The second method is referred to as the bolus dosage. This is an instant larger dosage that is generally administered befo

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

re eating.

The pump is programmed to deliver the correct dosages based on the individuals circumstances. If the individual changes diets or ad

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

pts a new exercise regime the dosages and the times that they are delivered can be altered.

The insulin used in insulin pumps is fast acting i

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

Following aspects would a

sulin so it is believed to be a better alternative to most syringe administered insulin, that is slow acting, and is generally an approximation

dd to the challenges in developing combination products:

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

of the amount of insulin that will be needed by the body.

Insulin pumps have a better idea of the amount of insulin that will be needed by th

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

body which is better for the long term health of the diabetic. They allow the diabetic more freedom and to eat or exercise when they want. The

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

are also more discrete than a syringe.

On the negative side, an insulin pump has to be worn all the time so it might be inconvenient for some

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

people that play sport or swim. Strategies have to be developed as a work around for these situations. Insulin pumps are more expensive than t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e normal syringe method of insulin therapy. Changing from slow to fast acting insulin may cause diabetic ketoacidosis if the fast acting insuli

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

is stopped for some reason, like the supply runs out for example or the cannula gets detached.

Research continues to improve the pumps in ter

.

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

ms of features and size. It is thought that ultimately an insulin pump will be the best method to deliver insulin therapy because it is a more

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

Companies that provide selfless information through particip

recise dosage and is less obtrusive. As development continues the price will inevitably drop and make an insulin pump accessible to most people

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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The world is going digital and people are crazy bout the hi-tech gadgets available in the market. But significantly paving the way is one of the hottest consumer products of the 21st century - the di...

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