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Lithium Ion batteries were invented as long ago as 1912 by Gilbert N. Lewis, but it was a long time before they were developed enough to be launched on a mass market level. This happened in the ear

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

ly 1990’s with Sony pioneering their commercial use.

Lithium Ion batteries have many advantages.

They can be constructed in a wide variety of shapes and sizes, resulting in them being tailored to

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

Examples of combination products may in

he available space in the device in which they are to be used.

The batteries are also much lighter than other equivalents, due to the nature of the material and the high open circuit voltage compar

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

d to other batteries. This low weight makes it ideal in hand held and mobile devices for obvious reasons, and popular in these days of high tech gadgets.

Another major advantage is that they do not

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

suffer from memory effect. This is the condition, whereby other rechargeable batteries, if not fully discharged before recharging, lose their maximum energy capacity over time and thus hold less cha

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

Combination pro

rge.

They also do not have such a drastic self discharge rate as other batteries – just 5% per month, compared with up to 30% per month in other battery types. However, Lithium Ion batteries are n

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

t perfect, and there are drawbacks.

One of these is that their life span depends upon their age – and not the time from which they were charged, or the number of times they have been charged. They

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

egin to lose capacity gradually from the date of manufacture irrespective of the amount of charging cycles they have. Therefore the manufacturing date is useful to know,e specially if there is a big

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

time lapse from manufacture to being used e..g due to storage.

Some Lithium Ion batteries (such as laptop batteries) can lose around 20% of their capacity per year, when stored at normal temperatur

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

es. However, when exposed to prolonged higher temperatures, this figure can increase to as much as 35% per year. Another key factor is the charge level – when stored partially charged, these figures

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

can be dramatically reduced.

This makes Lithium Ion batteries unsuitable for certain applications – such as back up batteries.

The battery must never be discharged below a certain threshold, other

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

Following aspects would a

ise the battery will be damaged irreversibly. Therefore, the devices that use them have a built in system to shut them down when the charge level meets that minimum threshold. For this reason, Lithi

dd to the challenges in developing combination products:

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

m Ion batteries are designed and manufactured specifically for the device they are to power and are not available as generic batteries.

Having said that, there are some versions available that hav

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

e a built in circuit to monitor the minimum charge level and shut the battery down when it reaches that level. These are known as “smart” batteries.

How to prolong the life of your Lithium Ion batt

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

ry

- Charge the battery early and often , unlike other rechargeable batteries.

- If you do not intend to use the battery for a long time, charge it to a level of approximately 40% of capacity.

-

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

he battery should be kept cool. They will age faster at higher temperatures, so keep as cool as possible when not in use. They can be safely stored in a refrigerator for optimum prevention of aging

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

Professional from academic institutions, pharmaceutical industries, health care indust

(note: they should not be frozen)

- If the device you are using is often run from a mains power supply (e..g laptop) and it is possible, remove the battery when using mains power. This prevent the

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

battery from being subjected to high prolonged temperatures which can shorten it’s life.

- Any steps to reduce the heat that the battery is subjected to will benefit it’s lifespan.

- When purchas

.

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

ng replacements, try to purchase a battery that has the shortest possible time from manufacture to retail. (though it may be difficult to find out this information).

In short Lithium Ion batteries

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

Companies that provide selfless information through particip

re a very versatile battery, ideal in lightweight applications and not subject to memory effect. However, they do degrade at higher temperatures which means they are not a universal battery solution

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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