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This is a question that people often ask but is actually a very difficult one to answer. Addiction is not just one single and simple process, it is a comple

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

x process that has both physical and psychological aspects. Nevertheless despite this complexity two attempts have been made to determine the most addictive

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

Examples of combination products may in

drug. Independently Dr. Jack E. Henningfield of the National Institute on Drug Abuse and Dr. Neal L. Benowitz of the University of California at San Francisc

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

, ranked six psychoactive substances, nicotine, heroin, cocaine, alcohol, caffeine and marijuana, on the five criteria they felt were most important in addic

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

tion.

The first of these criteria was withdrawal. This is defined as the severity of withdrawal symptoms produced by stopping the use of the drug. Both re

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

Combination pro

earchers rated alcohol as having the most severe withdrawal symptoms, for example hallucinations and convulsions, and the fact that withdrawal from alcohol i

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

the only one of the included drugs that is potentially fatal.

The second criterion is reinforcement, that is the drug's tendency to induce users to take it

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

again and again. This is influenced by the feelings that taking the drug brings, that is whether it is a pleasurable high or not, obviously if the feelings

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

are negative there will be little incentive to repeat the experience. Again both researchers were in agreement and rated cocaine as the most reinforcing.

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

e third criterion was tolerance, this is defined as the user's need to have ever-increasing doses to get the same effect. For the first time the researchers

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

disagree with Henningfield rating heroin first and Benowitz rating cocaine.

The fourth criterion is dependence. This is defined as the difficulty in quitti

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

Following aspects would a

ng, or staying off the drug, usually measured by the number of users who eventually become dependent. For many dependence is viewed as the hallmark of addic

dd to the challenges in developing combination products:

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

ion and how ‘addiction’ is usually measured by the medical profession. For this criterion both researchers are again in agreement as they rate nicotine high

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

st for dependence. For the other drugs they both rated them in the same order that is highest for dependence, nicotine, then heroin, cocaine, alcohol, caffe

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

ine and last marijuana.

The final criterion is intoxication. This is the degree of intoxication produced by the drug in typical use. Again the researchers

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

are in agreement and rate alcohol as the most intoxicating of the drugs.

Given the complexity of the addictive process it is not surprising that there is no

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

Professional from academic institutions, pharmaceutical industries, health care indust

a clear ‘winner’ in all criteria. What some may find surprising is that for both researchers caffeine ranked higher than marijuana on a number of the crite

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

ria and indeed Berowitz rates caffeine higher than marijuana for dependence.

These results have been quoted many times by many researchers, commentators and

.

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

reporters. They are usually interpreted as nicotine, or tobacco smoking, being named the most addictive substance purely on the definition of the difficulty

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

Companies that provide selfless information through particip

in refraining. What the results do show is that addiction is a complex and multi-facetted activity and that it is impossible to reduce it to a simple metric

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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