Nicorette

An anti-smoking gum

Because Living Longer Matters….

 Contents:-

1. The facts about smoking

2. Product planning
3. The Process
4. Concept Development
5. Functionality of the product
6. Production process
7. Detail Design
8. Testing and Refinement
9. Production Ramp up
10. Design
11. Details about the issues about the procuct.
Some Facts

• Cigarette smoking is without question, the greatest single public health problem our
nation has ever faced. Smoking kills more people each year than AIDS, fires, car
accidents, murders, suicides, alcohol and other drugs combined.

• Tobacco is toxic to the body. It is addictive and each time a person smokes a
cigarette you are taking away 5 to 20 minutes of their life.

• To smoke or not to smoke, however, is a decision that has to be made by the

individual. It is a fact that cigarette smoking is harmful, but it is not accepted
generally by everyone.

• For cigarette smokers who do accept this, efforts can be made to help
them.
What you need to know about quitting
smoking:-
Generic Architecture followed in New Product Development
PRODUCT PLANNING

Project mission statement

To provide an anti-smoking remedy for smokers that is effective,
easily available and cost effective.
Target market segment
Our target market is heavy smokers, medium – low smokers,
early birds … basically everyone who lights a cigarette.
Business goals
To establish a market for anti smoking remedies in the Indian
scenario in the next 10yrs

Constraints
user acceptance and extensive R&D
THE PROCESS

The entire “drug discovery” process takes an

average of 12 – 15 years to complete.
 
Basic Research Stage – Years 0-3
During this time period, thousands of substances are being
developed, examined and screened.
 
Development Stage – Years 4-10
During this time, 10-20 substances are tested, both in
vitro (within an artificial environment) and in vivo
(within a living body).
THE PROCESS

Preclinical Testing for years 4,5,6

Clinical Testing for years 7,8,9 and10
Phase I - clinical testing on 5-10 substances
Phase II - clinical testing on 2-5 substances
Phase III - clinical testing on 2 substances
 
Registration of the drug with the Food and Drug
Administration

  Introduction of the drug to the public – Years 11+

Product Surveillance done on people for years 11,12,+
Phase IV - observations/monitoring the product
 
 
 
CONCEPT DEVELOPMENT - THE CONDITIONED REFLEX

Anti-smoking Nicotine gums

• Easy to carry around

• Easy to pack
• Can be bought in quantities as required
• Not a resistive drug method like injections or
sessions
How does it work:-

• Nicorette gum contains nicotine. Nicotine is the

addictive substance present in tobacco. Smokers
who try to give up often experience unpleasant
withdrawal symptoms and cravings for cigarettes,
because they are dependent on the nicotine in
tobacco.
• It Gives a small amount of nicotine, but without the
dangerous effects of inhaling tobacco smoke. The
nicotine released from chewing Nicorette gum is
absorbed into the bloodstream from the lining of your
mouth.
• You should chew the gum whenever you have an urge to
smoke and this will help you to break the smoking habit
and not start smoking again.
Production process

1 Melting
2 Mixing
3 Rolling
4 Scoring
5 Conditioning
6 Wrapping
7 Packaging
Melting

The making of gum begins by melting and purifying the gum

base, which comes in form of small round balls.

butadiene-styrene rubber,
polyethylene,
polyvinyl acetate .
Mixing

• The melted base is poured into a mixer that can hold up to one
ton of ingredients.
• Sucrose ,Acacia , Asafoetida ,Sodium Bicarbonate ,Pure
Glycyrrhizin are mixed thoroughly in the mixer.
• flavours and sweeteners are added.
Rolling

From the mixers, a large "loaf" of gum is sent through a

series of rollers that form it into a thin, wide ribbon.
Each pair of rollers is set closer together than the
previous pair, gradually reducing the thickness of the
gum. A light coating of finely powdered sugar or
sugar substitute is added during this process to keep
the gum from sticking and to enhance flavour.
Scoring

At the end of the rolling process, the continuous ribbon

of gum is then cut into a different patterns
: sticks or small rectangular gum centers, depending on
what type of gum is being made
Conditioning
The scored gum is then moved to a temperature-controlled
environment. to cool and ensure the finished gum will have the
right consistency and stay fresh on store shelves.
Wrapping

After cooling and tempering, skilled operators break

the sheets of sticks up into sections and feed them
into the wrapping machine. In one continuous
process, the wrapping machine receives and wraps
the sticks, applies the outer wrapper, and seals the
end of the package
Packaging

This is where the pellet-style gum is put into the formed plastic
compartments of the blister pack. The package is heat sealed
using a foil and cardboard sleeve.
DETAIL DESIGN

Each lozenge contains the following formula:

Sucrose 1 mg.
Acacia 50 mg.
Asafoetida 65 mg.
Sodium Bicarbonate 25 mg.
Pure Glycyrrhizin 40 mg. (Extract of Liquorice)
Nicorette gum is available in two strengths:

The 2mg gum :-smoke less than 20 cigarettes a day, or

whose first cigarette of the day is more than 30 minutes
after waking.
The 4mg gum :-people who smoke more than 20
cigarettes a day, or whose first cigarette is within 30
minutes of waking.
TESTING AND REFINEMENT

Preclinical Testing
with volunteers

Clinical Testing
Phase I - early birds
Phase II - light – medium smokers
Phase III - heavy smokers 
 NicAlert Test:-

• The NicAlert Saliva Nicotine test is a new nicotine testing system

using a saliva sample. Incorporating a recently developed and
highly sensitive chromo graphic lateral flow strip type testing device
along with a special collection device for human saliva samples

• The NicAlert nicotine test is a self-contained, ready to use, point of

contact drug testing device that detects the presence of cotinine, the
principal metabolite(Metabolites are the intermediates and products
of metabolism) of nicotine in human saliva samples.

Advantages:-
• No special training to complete and semi-quantitative results are
visibly obtained within minutes.
• The NicAlert™ test is highly sensitive and will detect
even the smallest concentrations of cotinine. Each test
strip is divided into six (6) reactive chromo-graphic (color
change) levels of cotinine detection. Results are semi-
quantitative based on the following detection matrix:
PROCEDURE FOR • Collect the oral fluid sample by using the
SALIVA NICOTINE funnel device and collection container
TESTING: provided. The test subject should spit
into the funnel until the collection
container is filled at least one third with
saliva. Strip should not be directly put in
the subject's mouth as the strip will not
react properly.

• Remove the funnel from the collection

container and plug the larger open end
with the stopper provided.

• Lay the NicAlert™ test device on a dry

flat surface with the numbered levels
facing up.
INTERPRETATION OF RESULTS

• Wait 20 minutes for test results to fully develop. Test

results are read by observing and scoring level at which
the color change stops:
TESTING AND REFINEMENT
Refinement

• This step continues along with the testing process.

• Here, the field testing and follow up of results is done.
• New methods to overcome challenges such as side
effects and means to overcome will clearly be discussed.
• The education as to how the dosage is to be taken has
to be provided to the people.
• This education can be in terms of documentary videos
and also through awareness campaigns near colleges,
hospitals, companies and industrial sites.
• Also, proper follow up of clinical testing is to done and
results are to be documented.
PRODUCTION RAMP UP
• This being a manufacturing of a new medicine, batch
processing would be the best solution for production
ramp up.
• Based on the influence and demand in the market, the
product would be launched.
• Also, this being a fundamentally new product, the scope
of this is high.
• There are so many cases of people who wish to stop
smoking but are unable to do so.
• So the wisest decision would be to wait for the success
of the test phases and then go about mass production.
Things to be taken care of :-

• Nicorette gum should be chewed in the special way

explained in the instructions in the package leaflet. If
chewed the gum continuously, the nicotine is released
too quickly and may be swallowed. This can cause side
effects such as throat and stomach irritation, indigestion
or hiccups.

• Not to exceed the recommended dose of this medicine,

which will be stated in the product packaging or
information leaflet supplied with the medicine.
• Acidic drinks such as coffee, sodas and fruit juices can
reduce the amount of nicotine that is absorbed from the
mouth if it is taken in the 15 minutes prior to chewing
nicotine gum.
• Make sure you do not leave unused or used Nicorette
gum where children can reach it. Doses of nicotine that
are tolerated by adult smokers during treatment can
produce severe symptoms of poisoning in small children
and may prove fatal. Disposal of Nicorette gum should
be carefully made.
Use with caution in:-

• Adolescents aged 12 to 18 years old.

• Disease involving the heart and blood vessels (cardiovascular
disease)
• Diabetes. (Monitor blood sugar more closely when starting
NRT.)
• Peptic ulcer:-Inflamed stomach lining (gastritis)
• Inflammation of the food pipe (oesophagitis)
• Inflammation of the mouth or throat.
• Overactive thyroid gland (hyperthyroidism):-Tumour of the
adrenal gland (phaeochromocytoma). Severely decreased
kidney function. Moderate to severely decreased liver function.
Side effects

Just because a side effect is stated here does not mean that
all people using this medicine will experience that or any
side effect.

• Sore mouth or throat.

• Throat irritation.
• Increased salivation.
• Hiccups.
• Dizziness.
• Headache.
• Nausea.
• Heartburn or indigestion (slower chewing or using 2mg gum may reduce this
problem).
• Jaw ache.
• Awareness of heartbeat (palpitations).
• Mouth ulcers.
Thank you