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Cocaine and crack are both classified as Class A drugs and are ‘controlled drugs’ under the Misuse of Drugs Act. Other than for licensed medi

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

cal uses, both substances are illegal to produce, supply or possess. It is also illegal to allow premises ‘that you control or manage’ to be

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

Examples of combination products may in

sed for production, supply or use of crack or cocaine.

The maximum penalty in the UK for possession of these substances is seven years impri

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

sonment. The maximum penalty for supplying crack or cocaine is Life Imprisonment.

Crack and cocaine are not physically addictive, that is t

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

say any addiction a user may have is purely psychological.
Street names
Cocaine is known as coke, charlie, C,

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

Combination pro

white. Crack is known as rocks, wash, stones, pebbles. Cocaine is a crystalline white powder that can be snorted up the nose. Some users

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

nject it. Crack is a freebase form of cocaine which can be smoked.
Base or Freebase
Freebase is the process

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

of returning the cocaine powder to a baser form using, most commonly, ether or ammonia. Freebasing produces small, crystallised pieces of coc

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

ine that are normally smoked.
Crack
Crack is more or less the same thing as Freebase except that different che

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

micals are used in the ‘washing’ process and crack crystals are normally larger than freebase crystals. It’s often referred to as ‘rocks’, ‘s

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

ones’ and ‘bones’. It’s reported that the speed of effect is between five and ten seconds which can produce a ‘high’ of five to ten minutes.

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

Following aspects would a

Smoking crack is the most rapid and by far the most dangerous method of taking cocaine.
Health Problems
There

dd to the challenges in developing combination products:

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

s no safe way to take crack or street cocaine and every user takes risks with their health every time they use the drugs. There are many heal

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

th problems associated with crack and cocaine use. Particularly:

Heart problems Brain damage or stroke Respiratory problems Psychiatric p

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

oblems
Relatively Uncommon
Crack, like heroin, still remains a relatively uncommon drug among the general popu

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

lation. Figures from the British Crime Survey show that crack use is still very rare with only 0.1% of 16-59 year olds reporting having used

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

Professional from academic institutions, pharmaceutical industries, health care indust

t. Crack is also the only drug more prevalent among black people, particularly young black men, than whites or other ethnicities.

Use of cra

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

ck, unlike cocaine, is often localised and linked with social exclusion and deprivation in inner city areas. For example, seizures and arrest

.

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

for crack are greatest in the London area, making up 60 per cent of the UK's seizure figures.

Recent figures also show arrests and seizures

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

Companies that provide selfless information through particip

are on the increase. Since 1994, for example, the number of seizures for crack for the UK rose from 1,321 to 2,507 in 1999 and 4,260 in 2002

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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