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Introduction

Antibiotics are said to be the greatest contribution of modern day science helping the doctors to think beyond microorganinsms.their importance is

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

felt much more in developing countries where the infections are prevalent. There is a mushrooming of antibiotics since last few decades because of both the need

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

Examples of combination products may in

and the demand of aseptic conditions both in and out of the hospital.

What are antibiotics?

Antibiotics are chemical or biological substances either produced b

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

y microorganisms or are produced artificially to kill or inhibit the growth of other microorganisms. They are used at very low concentrations.

What are differen

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

types?

As there are innumerable antibiotics that are presently in use, different people classify them differently for e.g. those that kill or those just inhibi

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

Combination pro

t the action of the microorganisms, according to their chemical nature, according to the types of organisms they kill, according to the no of different types of

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

microorganisms, their mechanism of action and so hence and so forth. Hence sulfadiazine and others are sulfonamides while isoniazid is nicotinic acid derivative

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

, etc. tetracyclines are bacteriostatic while vancomycin is bactericidal.

How do they work?

Some antibiotics for e.g. penicillins inhibit the cell wall synthes

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

is of the bacteria, some like acyclovir inhibit the DNA synthesis, some like sulfonamides interfere with the metabolism and still others like tetracyclines inhib

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

it protein synthesis. Similarly there are many others with different mechanism of action meant to be targeted at specific function of the bacteria or virus.

Is

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

here any need for them?

After their discovery and then introduction into the world of medicine, initially they were used judicially but nowadays as more and mor

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

Following aspects would a

e antibiotics are being developed and there has been a pressure over the physicians for an aseptic environment , these type of drugs seem to be overused. This ha

dd to the challenges in developing combination products:

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

s caused many fold problems. One problem is of toxicity that means that if the dose is much larger than expected then it may lead to accumulation in the body and

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

may even lead to death in some cases. Second problem is of hypersensitivity, which means that certain antibiotics for e.g. penicillins can cause hypersensitive

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

eactions in the body, which at times may be quite severe. But the most important problem and the problem, which has attracted much concern among the medical frat

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

ernity, is that of resistance. Certain microorganisms for e.g. Staphylococcus are known to get quick resistance against the antibiotics and you need to be cautio

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

Professional from academic institutions, pharmaceutical industries, health care indust

us before using them blindly.

What do we mean by resistance?

By resistance we mean that a microorganism is either not responding or responding minimally to an

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

ntibiotic to which that microorganism used to respond earlier. There are numerous mechanisms by which they develop resistance and this may be making themselves i

.

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

mpermeable to the drugs or making them inactive or mutating themselves, etc.

What is the latest research going on?

At present the latest research that is going

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

Companies that provide selfless information through particip

on is to how to reduce the use of antibiotics by using them judicially so that the microbes might not fall to the prey of resistance and then be of no use to us

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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