Professional Documents
Culture Documents
Nicotine Replacement Therapy (Nicotex)
Nicotine Replacement Therapy (Nicotex)
Smoking”
Degree
Of
Julee Gogoi
A0500108023
ACKNOWLEDGEMENT
1
“TO THE ALMIGHTY FOR THE ASPIRATION AND INSPIRATION”
It is our honors to state that we are very grateful to our institution AMITY UNIVERSITY
for envisaging such a stupendous project.
At the outset, I would like to place on record my gratitude to all those who have been
instrumental in shaping up this project with their guidance and inspiration.
I express my hearty respect and profound thanks to Mr. Gaurav Gupta for his valuable
guidance in completing my project and also his sincere cooperation in directing and
guiding me enabled the project to assume its systematic shape.
Last but not the least I must express my gratitude to my family and various friends who
gave moral support for completing this project work.
Julee Gogoi
MBT/08/1027
TABLE OF CONTENTS
1. Certificate…………………………………………….. …………1
2
2. Acknowledgement……………………………………………. .2
3. Table of contents………………………………………………..3
4. Executive Summary…………………………………………….5
5. Introduction……………………………………………………..6-31
5.2 History
5.3 Vision
5.8 Achievements
5.9 Awards
7. Literature Review……………………………………………….34-48
3
7.2 What is smoking?
8. Research Methodology…………………………………………49
9. Data Analysis……………………………………………………53
11. Conclusions……………………………………………………..62
12. Recommendations……………………………………………...64
13. References……………………………………………………….65
4
EXECUTIVE SUMMARY
The project work thoroughly looks into the adverse affects of smoking and also those who
take tobacco directly. The main culprit causing such deleterious effects on the human body
was thought to be nicotine. It causes diseases like lung cancer, hypertension, asthma,
bladder cancer, throat cancer, stroke of central nervous system. There are about 1.2 billion
smokers in the world, in which half of them are supposed to die by the diseases caused by
smoking.This report aims at drawing a picture of peoples attitudes towards smoking,
exposure to passive smoking and provision of cigarettes across an area. Unless stated
otherwise, in this report the term ‘current smokers’ includes both occasional smokers (less
than 1 cigarette a day) and regular smokers (more than 1 cigarette a day).
The introduction of Nicotine Replacement Therapy (NRT), the most recent U.S.
Department of Health and Human Services (DHHS) recommended NRT for first line
treatment to cut down addiction has successfully led to a decrease in the mortality and
morbidity and to better quality of life in tobacco smokers. NRT is available in various
formulations like transdermal patch, chewing gum, nasal spray, inhaler and lozenge.
Most of the studies were performed in people smoking more than 15 cigarettes a day. The
limited evidence suggests that there is overall difference in effectiveness of different forms
of NRT or a benefit for using patches beyond 8 weeks. NRT works with or without
additional counseling, and does not need to be prescribed by a doctor. Heavier smokers
may need higher doses of NRT. People who use NRT during a quit attempt are likely to
further increase their chance of success by using a combination of the nicotine patch and a
faster acting form. Preliminary data suggests that starting to use NRT shortly before the
planned quit date may increase the chance of success. Adverse effects from using NRT are
related to the type of product, and include skin irritation from patches and irritation to the
inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk
of heart attacks.
5
INTRODUCTION
The government has identified tobacco control as a key part of its approach to improving
health and reducing inequalities. People need to be protected from the harmful effects of
tobacco through education, legislation, cessation support and provision of smoke free
environments. In order for appropriate intervention mechanisms to be developed and their
effectiveness to be measured, it is essential that we obtain data on current smoking
prevalence, attitudes and trends. For planners of services and interventions, this data must
be developed into useful information demonstrating the various issues related to tobacco
usage. This report aims at drawing a picture of peoples attitudes toward smoking, exposure
to passive smoking and provision of cigarettes across an area. Unless stated otherwise, in
this report the term ‘current smokers’ includes both occasional smokers (less than 1
cigarette a day) and regular smokers (more than 1 cigarette a day).
Cigarette smoking is a modern epidemic. This legal addiction has its origins in
childhood and once established is extremely difficult to reverse. The rate of smokers are
increasing and mostly targeting the youngsters. Smoking among the adults are more than
the elders due to unawareness among the youngsters and the misconception of feel good
factor. This is due to the presence of nicotine in the cigarettes and gutkha. It was found that
nicotine is a cause of addiction. 45% among them are females who smoke for loosing
weight and to look beautiful.
COMPANY PROFILE
6
Founded 1935
Headquarters Mumbai, India
“There’ll Key people Y. K. Hamied (CMD), Chairman
always be a Industry Pharmaceuticals
healthier way Revenue ▲ Rs. 37.6 billion (~939M USD) (2006)
to live, a Net income ▲ Rs. 9.1 billion (2006)
warmer way to Employees over 7,000
care, a surer Website http://www.cipla.com/
way to heal, a calmer way to sleep. There’ll always be a better world, for those who have
the passion to create it”.
That’s been Cipla’s belief since 1935, when it began as a small Indian enterprise committed
to the nation’s quest for self-sufficiency. The War that followed saw Cipla rise to the
challenge of meeting the alarming shortage of essential medicines.
Over the years their commitment to heal, protect and enrich lives has only grown, and so
have their capabilities.
HISTORY
7
when he was 15 as he witnessed a wanton act of colonial highhandedness. The fire
was to blaze within him right through his life.
CIPLA IS BORN
The search for suitable premises ended at 289, Bellasis Road (the present corporate
office) where a small bungalow with a few rooms was taken on lease for 20 years
for Rs 350 a month.
Cipla was officially opened on September 22, 1937 when the first products were
ready for the market. The Sunday Standard wrote: "The birth of Cipla which was
launched into the world by Dr K A Hamied will be a red letter day in the annals of
Bombay Industries. The first city in India can now boast of a concern, which will
supersede all existing firms in the magnitude of its operations. India has lagged
behind in the march of science but she is now awakening from her lethargy. The
new company has mapped out an ambitious programme and with intelligent
direction and skillful production bids fair to establish a great reputation in the
East. "
8
July 4, 1939 was a red-letter day for Cipla, when the Father of the Nation,
Mahatma Gandhi, honoured the factory with a visit. He was "delighted to visit this
Indian enterprise", he noted later. From the time Cipla came to the aid of the
nation gasping for essential medicines during the Second World War, the company
has been among the leaders in the pharmaceutical industry in India.
On October 31, 1939, the books showed an alltime high loss of Rs 67,935. That
was the last time the company ever recorded a deficit.
9
In 1944, the company bought the premises at Bombay Central and decided to put
up a "first class modern pharmaceutical works and laboratory." It was also decided
to acquire land and buildings at Vikhroli. With severe import restrictions
hampering production, the company decided to commence manufacturing the basic
chemicals required for pharmaceuticals.
Dr Yusuf Hamied, the founder's son, returned with a doctorate in chemistry from
Cambridge and joined Cipla as an officer in charge of research and development in
1960.
In 1961, the Vikhroli factory started manufacturing diosgenin. This heralded the
manufacture of several steroids and hormones derived from diosgenin.
The whole of Cipla was plunged into gloom on June 23, 1972 when Dr K A
Hamied passed away. The Free Press Journal mourned the death of a "true
nationalist, scientist and great soul…. The best homage we can pay to him is to
contribute our best in the cause of self-reliance and the prosperity of our country
in our fields of endeavour."
MILESTONES
10
1935
Dr K A Hamied sets up "The Chemical, Industrial and Pharmaceutical Laboratories
Ltd." in a rented bungalow, at Bombay Central.
1941
As the Second World War cuts off drug supplies, the company starts producing
fine chemicals, dedicating all its facilities for the war effort.
1952
Sets up first research division for attaining self-sufficiency in technological
development.
1960
Starts operations at second plant at Vikhroli, Mumbai, producing fine chemicals
with special emphasis on natural products.
1968
Cipla manufactures ampicillin for the first time in the country.
1972
Starts Agricultural Research Division at Bangalore, for scientific cultivation of
medicinal plants.
1976
Cipla launches medicinal aerosols for asthma.
1980
Wins Chemexcil Award for Excellence for exports.
1982
Fourth factory begins operations at Patalganga, Maharashtra.
1984
Develops anti-cancer drugs, vinblastine and vincristine in collaboration with the
National Chemical Laboratory, Pune. Wins Sir P C Ray Award for developing
inhouse technology for indigenous manufacture of a number of basic drugs.
11
1985
US FDA approves Cipla's bulk drug manufacturing facilities.
1988
Cipla wins National Award for Successful Commercialisation of Publicly Funded
R&D.
1991
Lauches etoposide, a breakthrough in cancer chemotherapy, in association with
Indian Institute of Chemical Technology.
1999
Launches Nevirapine, antiretroviral drug, used to prevent the transmission of
AIDS from mother to child.
2000
Cipla became the first company, outside the USA and Europe to launch CFC-free
inhalers – ten years before the deadline to phase out use of CFC in medicinal
products.
12
2002
Four state-of-the-art manufacturing facilities set up in Goa in a record time of less
than twelve months.
2003
Launches TIOVA (Tiotropium bromide), a novel inhaled, long-acting
anticholinergic bronchodilator that is employed as a once-daily maintenance
treatment for patients with chronic obstructive pulmonary disease (COPD).
CIPLA TODAY
13
Today cipla have 31 world-class manufacturing facilities spread across the country, with
dedicated plants for Oncology products, Hormones, Inhalers, Carbapenems, and
Cephlosporins, among others. They more than meet the stringent international standards,
such as that of US FDA, MHRA–UK, TGA Australia, BFarm–Germany MCC–South
Africa, WHO, TPD- Canada.
Its API manufacturing plants are today among the most sophisticated in the world, capable
of complex multi-stage syntheses, and produce over 120 API’s from high potency actives
in grams to those made in several tonnes.
Cipla produces one of the widest range of products and dosage forms in the world today,
everything from metered-dose inhalers, pre-filled syringes, trans-dermal spray patches,
lyophilized injections, nasal sprays, medical devices, and thermolabile foams. Whether it is
constantly extending our product range or consistently introducing innovations, the mission
is always to make the life of the patient better
Cipla is unlikely to be hit by forex-related activity, going ahead, since it has accounted for
all such activity, provided there is no major rupee-related fluctuation, he said. There has
been an increase of 49 per cent in other expenditure (Rs 122 crore) on account of sales
expenditure, foreign exchange loss and year-end provisions
14
While there’ll be patients who are beyond cure, they should be never beyond care. The
Cancer Palliative Care Centre for the terminally ill is Cipla’s labour of love for the patients
and their families. A training institute for the medical community, arising from a belief
that if we can’t heal their disease, we must try and heal their pain.
VISION
Cipla started with a vision to build a healthy India. Along the way realized, that in our own
small way, we could contribute to making the world a healthier place. We’ll continue to
bring a smile on as many faces as we can to heal the world as much as we can.
Because there’ll always be a better world out there for those who have the passion to create
While our skills are among the best in the world, what makes us different is our multi-
disciplinary approach to research.
Our research capabilities are extensive, from Chemical Synthesis, Delivery Systems and
Medical Devices to Process Engineering, Animal Health Products, Neutraceuticals and
Biotechnology.
We believe there’s no use in developing life-saving medicines if we can’t make them
affordable for the patient.
Today, across 170 countries, there are millions of patients who get to use a Cipla product to
prevent, to cure, or for relief from suffering. In their cure and relief lies the ultimate
purpose of what they do.
At Cipla, this has been the driving force behind our continuous quest for quality. And
quality is an obsession here for the 7000 people who walk into work every morning.
World-class quality is reflected in everything we do – from start to finish.
You’ll see concern for the environment in our manufacturing processes, air and water
systems, safety practices, and above all, in its people.
It strive not just to meet international specifications, but to exceed, to excel, to meet what
we call the Cipla benchmark. In fact, it have set standards for the world to follow and have
contributed to more than 125 monographs in the last 15 years - to British, European, US
and international pharmacopoeia.
15
Today companies from around the world seek strategic alliances with Cipla for product
development, technical support and marketing. In a small way, they even help countries set
up their pharmaceutical infrastructure and train their professionals, contributing to their
quest for self-reliance just the way we began healing India, seven decades ago.
Over the years, they have taken on the challenges facing the world, tackling the newer
dimensions of diseases, like AIDS. At a time when it was a death sentence and medication
was unaffordable to most, Cipla opened the doors of hope to millions and millions of
patients by becoming the first company in the world to offer the Triple-Drug AIDS
Cocktail for less than a dollar a day. One out of every three HIV-AIDS patients under
treatment in Africa uses a Cipla drug.
Equally inspiring has been Cipla’s fight against asthma. We partnered with the medical
fraternity to shatter myths, spread awareness and empowered asthma patients to lead a
fuller life. We have the world’s largest range of asthma medication and delivery systems.
This relentless commitment to asthma inspired us to set up the Chest Research Foundation.
It’s one of the few Institutes in the world that’s dedicated to clinical and allied research in
the field of Chronic Respiratory Diseases.
Technology Services
Cipla offers services like consulting, commissioning, engineering, project appraisal, quality
control, know-how transfer, support, and plant supply.
Apart from its presence in the Indian market, Cipla also has an export market and regularly
exports to more than 150 countries in regions such as North America, South American,
Asia, Europe, Middle East, Australia, and Africa. For the year ended 31 March, 2007
Cipla’s exports were worth approximately Rs. 17,500 million. Cipla is also considerably
well-known for its technological innovation and processes for which the company received
know-how loyalties to the tune of Rs. 750 million during 2006-07. Cipla has been approved
by regulatory bodies such as:
16
• Therapeutic Goods Administration (TGA), Australia
• Pharmaceutical Inspection Convention (PIC), Germany
• National Institute of Pharmacy (NIP), Hungary
Cipla has recently launched i-Pill which is a single dose emergency contraceptive and has
acquired a great deal of popularity in a short span of time. Other latest launches of Cipla
include products such as Nova, Moxicip, Flomex, Fullform, Montair LC, and Imicrit.
CIPLA PRODUCTS
17
Cipla's products include:
Prescription:
• Alzheimer’s disease- Donepezil,Rivastagmine
• Antimalarial- Amodiaquine,Artemether 53mg
• Cardiovascular drugs- Amlodipine,Captopril
• Immunosuppresants- Cyclosporin,Tacrolimul
• Anti cancer-Cisplatin,Anastrazole
• Respiratory drugs-Albuterol sulphate
• Antiretroviral drugs -Didanosine
18
Animal Health Care Products: These include: aqua products, equine products, poultry
products, products for companion animals, and products for livestock animals.
19
Nicotex is form of nicotine replacement therapy which help to quit smoking. It is available
as nicotine polycrilex chewing gum in the strength of 2mg and 4mg.
i-pill –CONTRACEPTIVE
Contraceptive Pills - ipill is an emergency contraceptive pill manufactured by Cipla, to
avoid unwanted pregnancy
20
ANTIFLU
Cipla announced that Oseltamivir 75 mg capsules marketed as
`Antiflu` by the company has been included in the World Health
Organization (WHO) list of prequalified medicinal products
(PMP).
Oseltamivir is indicated for use in the treatment of influenza A
(H1N1) infection commonly known as swine flu.
antiretroviral therapy worldwide take Cipla drugs. Ranked third in Generic market share
statistics in South African Private Sector.
The customary treatment of AIDS consists of a cocktail of three drugs. Cipla produces an
all-in-one pill called Triomune which contains all three
substances (Lamivudine, stavudine and Nevirapine), something
difficult elsewhere because the three patents are held by different
21
companies. One more popular fixed dose combination is there, with the name Duovir-N.
This contains Lamivudine, Zidovudine and Nevirapine
Major Indian pharma firm Cipla has notified that it has secured tentative approval from the
United States Food and Drug Administration (USFDA) for its tenofovir disoproxil
fumarate tablets.
The drugs are prescribed for the treatment of HIV-1 infection in adults
Bosentan for pulmonary arterial hypertension – a rare & life threatening disease
Cipla has become the first company in India to manufacture and market bosentan under the
trade name BOSENTAS, a drug used to treat pulmonary arterial hypertension (PAH), a
life-threatening condition.
22
BOSENTAS (bosentan) is an orally active dual endothelin receptor antagonist (ERA).
Bosentan works by blocking the binding of endothelin (ET). ET is produced and secreted
by the endothelium, a monolayer of cells covering the inner surface of blood vessels
TM
The Autohaler is the first breath
actuated or activated pressurized
metered dose inhaler (BAI). This
overcomes the key problem of the
pressurized metered dose inhaler
(pMDI) viz. coordination of
actuation with inhalation and does
not rely on the patient's inspiratory
effort to aerosolize the dose of medication unlike dry powder inhalers . It is activated at low
flow rates of 22-30 l/sec
23
to reduce the severity of withdrawal symptoms and cravings. By stopping as early as
possible, there can be a reduction in the risk of cancer, lung and heart disease. There is also
a reduction in the damage caused to the lungs.
Nicochew chewing gum is indicated for smoking cessation therapy
24
CLACENT: Results - Sure Shot
25
• Treatment of Cryptococcal Meningitis in HIV infected
patients.
• Treatment of patients with Aspergillus species, Candida
species and/or Cryptococcus species infections refractory to or with
renal impairment or toxicity to AMB
• Treatment of visceral leishmaniasis.
26
INFLUVAC is an inactivated subunit vaccine for influenza. It contains surface
antigens (Haemagglutinin and Neuraminidase)
for 3 subtypes of influenza virus. This vaccine
complies with the World Health Organization
(WHO) recommendation (northern hemisphere)
and the competent authority decision for the
applicable season.
Flavour & Fragrance: Cipla manufactures a wide range of flavours, which are used in
foods and beverages, fruit juices, baked goods, and oral hygiene products. Cipla fragrances
have wide ranging applications such as in personal care products, laundry detergents and
room fresheners.
BULK DRUGS
Active Pharmaceutical Ingredients
Antibiotics
Anti cancer drugs
Anti malarial drugs
Cardiovascular drugs
CNS drugs
Drug intermediates
27
Cipla vs. S&P Nifty
(1 Year)
- Cipla has followed the market trend for the last 1 year; and
- In December 2008, Cipla somewhere breached the market line crossing it to end at
approx Rs. 600.
What’s in it for the investor?
- HOLD on to your stock to benefit from its “Capital Appreciation”;
- The “Estimations” showcase the company to be a healthy company with positive
and healthy FCFF;
- As of 9 December 2008 Cipla stands at Rs. 247. The price is Rs. 292
SWOT ANALYSIS
28
STRENGTHS
- Ranks #2 in the retail prescription market in India;
- 18 brands that feature among the top-300 brands;
- Large basket of 1,500 formulations; and
- Partnered 8 leading generics companies in the US for nearly 125 projects.
WEAKNESSES
- Impact of IPR regime.
OPPORTUNITIES
- Biotherapeutics – A new and promising area;
- Agreement with Avesthagen; and
- Venturing towards areas of cardiology and anti-cancer.
THREATS
- Partnership related; and
- Potential de-rating
STRATEGIC TIE-UPS
29
Subsidiary in Dubai: Cipla has set up a wholly owned subsidiary, Cipla FZE
situated at Jebel Ai Free Zone in Dubai, United Arab Emirates. This is the part of
strategy to explore the growing markets in middle east countries through exports.
Cipla entered agreement with Pentech Pharma of USA for marketing a range of
generic products for American market;
The first phase of the new formulation plant at Baddi, Himachal Pradesh, for the
manufacture of tablets and capsules commenced commercial production in April
2005; and
30
GLOBAL PRESENCE
Cipla's manufacturing facilities have been approved by: FDA, USA; MHRA, UK; TGA,
Australia; WHO etc
31
MAJOR ACHIEVEMENTS OF CIPLA
• Cipla became the first company, outside the USA and Europe to launch
CFC-free inhalers
AWARDS
• The Dun & Bradstreet - American Express Corporate Award for the best
company in the pharmaceutical sector.
32
AIM
BACKGROUND
The aim of nicotine replacement therapy (NRT) is temporarily to replace much of the
nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms,
thus easing the transition from cigarette smoking to complete abstinence.
OBJECTIVES-
To
33
SCOPE OF THE STUDY
34
LITERATURE REVIEW
Market research
• What is happening in the market? What are the trends? Who are the
competitors?
• How do consumers talk about the products in the market?
• Which needs are important? Are the needs being met by current products?
35
INTRODUCTION TO THE STUDY
Smoking harms nearly every organ in the body,
causes many diseases, and compromises smokers´
health in general. Nicotine, a component of
tobacco, is the primary reason that tobacco is
addictive, although cigarette smoke contains
many other dangerous chemicals, including tar,
carbon monoxide, acetaldehyde, nitrosamines, and
more.
The government has identified tobacco control as
a key part of its approach to improving health and
reducing inequalities. People need to be protected from the harmful effects of tobacco
through education, legislation, cessation support and provision of smoke free environments.
In order for appropriate intervention mechanisms to be developed and their effectiveness to
be measured, it is essential that we obtain data on current smoking prevalence, attitudes and
trends. For planners of services and interventions, this data must be developed into useful
information demonstrating the various issues related to tobacco usage. This report aims at
drawing a picture of peoples attitudes toward smoking, exposure to passive smoking and
provision of cigarettes across an area. Unless stated otherwise, in this report the term
‘current smokers’ includes both occasional smokers (less than 1 cigarette a day) and regular
smokers (more than 1 cigarette a day).
36
Comparative cause of annual deaths
WHAT IS SMOKING?
Smoking refers to the inhalation and exhalation of fumes from burning tobacco in cigars,
cigarettes and pipes.
Tobacco smoke contains nicotine - a poisonous alkaloid - and other harmful substances like
carbon monoxide
37
Ammonia - Toilet Cleaner
By adding ammonia to your cigarettes, nicotine can be absorbed through your lungs
more quickly. Two teaspoons of ammonia is deadly.
It is not Nicotine but the other compounds in tobacco smoke that cause trhe harmful effects
of the body. Tar is the store house of many carcinogens that are responsible for the
deleterious effects cause on human body, contrary to the belief that nicotine causes the
harmful effects like cancer.
WHAT IS NICOTINE?
NEUROBIOLOGY OF NICOTINE
38
• Evidence that nicotine is addictive
Most of the toxicity of smoking is related to other components of the tobacco smoke, the
pharmacological effects of nicotine produce the addiction to tobacco. There are many lines
of evidence for tobacco addiction and the role of nicotine in sustaining tobacco addiction.
The basic line of evidence is that most smokers state they would like to quit smoking but
are unable to do so easily. Nicotine also meets the Surgeon General’s primary criteria for
drug addiction, which state that the drug must:
1. promote compulsive use
2. have psychoactive effects
3. reinforce its own use
When a cigarette is smoked, nicotine rich blood passes from lungs to the brain within 7
seconds and immediately stimulates the release of many chemical messengers.
Nicotine receptor activation promotes the release of neurotransmitters, which may then
mediate various effects of nicotine use.
39
NICOTINE
SMOKING REACHES
BRAIN
ANOTHER DOPAMINE
CIGRETTE RELEASE
CALM AND
CRAVING
PLEASANT
FOR MORE
FEELING
• Withdrawl effects
Craving and withdrawal symptoms begin in chronic smokers when previously desensitized
nAchRs become unoccupied and recover to a responsive state during periods of abstinence.
These include irritability, depressed mood, restlessness, anxiety, problems getting along
with friends and family, difficulty concentrating, increased hunger and eating, insomnia
and craving for tobacco.
• Conditioning
Conditioning is a major factor that causes relapse to drug use after a period of cessation
40
HARMFUL EFFECTS OF SMOKING
41
for smokeless environments in public spaces such as government buildings, office
buildings and restaurants.
HEALTHY LUNG
You can see how the lung looks without the effects of
inhalation of smoke.
Note black specks throughout indicative of carbon deposits
from pollution
• Heart disease and strokes are also more common among smokers than non-smokers.
• Smoking causes fat deposits to narrow and block blood vessels which lead to heart
attack.
• Smoking causes around one in five deaths from heart disease.
• In younger people, three out of four deaths from heart disease are due to smoking.
• Cigarette smoking during pregnancy increases the risk of low birth weight,
prematurity, spontaneous abortion, and perinatal mortality in humans, which has been
referred to as the fetal tobacco syndrome.
42
Benefits of Quitting Smoking
When smokers quit, within twenty minutes of smoking that last cigarette the body begins a
series of changes.
43
Quitting smoking is a two-step process that includes:
1- breaking the smoking habit
2- overcoming the physical addiction to nicotine
The basic idea is to allow the smoker to break the cigarette habit before attempting to
actually get off the nicotine. This separates some of the difficulty of quitting from the
physical withdrawal and lets you do it in two stages.
Later the dosage is lowered and the smoker is slowly weaned off the nicotine
replacement.
44
NICOTINE REPLACEMENT THERAPY (NRT)
Cigarettes can be viewed as a "dirty" and dangerous method of delivering nicotine, while
NRT is a "clean" and safe method.
Mechanism of action
NRT acts in two ways
45
1)The principle mechanism of action of NRT is to partially replace the nicotine formally
obtained from tobacco. It provides small and sustained quantity of nicotine without the
harmful gases of smoking, to reduce the severity of withdrawal symptoms and cravings.
Ameriolation of withdrawal symptoms is observed with relatively low blood levels of
nicotine which also provides for some reinforcing and cognitive effects.
2)A second possible mechanism of benefit is the potential to desensitize nAchRs. Such
desensitization would result in reduced effect of nicotine from cigarettes, in case a person
relapses to smoking while taking NRT. Hence, NRT provide a coping mechanism, making
cigarettes less rewarding to smoke.
WHAT IS NICOTEX?
Nicotex is form of nicotine replacement therapy which help to quit smoking. It is available
as nicotine polycrilex chewing gum in the strength of 2mg and 4mg.
DOSAGE FORM
Chewing gum
46
HOW TO USE NICOTEX?
If smoking 25 or more cigarettes a day, use 4mg nicotine gum
If smoking less than 25 cigarettes a day, use 2mg nicotine gum
Use according to the 12 week schedule:
47
4. When the peppery taste or tingle is almost gone (in about a minute), again start
chewing the gum piece slowly. Stop when the taste or tingle returns.
5. Shift the gum to a different place in your mouth every time.
6. Repeat steps 4 to 7 until most of the nicotine is gone from the NICOTEX Chewing
Gum (usually happens in about 30 mins; the peppery taste or tingle will not return).
7. Wrap the used gum in paper and throw it away in the dustbin.
8. To improve the chances of quitting, use at least nine pieces of NICOTEX Chewing
Gum a day. If strong or frequent cravings are experienced, a second piece can be used
within the hour. However, continuous use of one gum piece after another is not
recommended, since this may cause hiccups, heartburn, nausea, or other side effects.
9. It is important to complete the NICOTEX quit programme at the end of 12 weeks,
and to stop using NICOTEX Chewing Gum at that time.
CONTRAINDICATIONS
NICOTEX Chewing Gum is contraindicated in patients with a hypersensitivity to
nicotine polacrilex or any other components of the chewing gum
SHELF-LIFE
2 years
STORAGE
Store at 20–25°C (68–77°F)
Protect from light
PACKAGING INFORMATION
NICOTEX Chewing Gum Pack of 10 gum pieces
WARNINGS AND PRECAUTIONS
• If patients continue to smoke, chew tobacco, use snuff, or use a nicotine patch or
other nicotine-containing products.
48
• In the presence of unstable heart disease, recent myocardial infarction, or irregular
heartbeat. Nicotine can increase the heart rate.
• In case of high blood pressure not controlled with medication. Nicotine can increase
blood pressure.
• Stomach ulcer or diabetes
• Using a non-nicotine stop-smoking drug.
• Taking prescription medicine for depression or asthma. The prescription dose may
need to be adjusted.
Stop if:
PHARMACOLOGY
Pharmacodynamics
The principal mechanism of action of nicotine replacement therapy (NRT) is to partially
replace the nicotine formally obtained from tobacco. It provides small and sustained
quantities of nicotine without the harmful gases of smoking, to reduce the severity of
withdrawal symptoms and cravings. Amelioration of withdrawal symptoms is observed
with relatively low blood levels of nicotine, which also provides for an alternative source of
some reinforcing and cognitive effects. A second possible mechanism of benefit has been
suggested to be the potential for nicotine medications to desensitize the nicotinic
acetylcholine receptors (nAchRs). Such desensitization would result in a reduced effect of
nicotine from cigarettes, such that if a person relapses to smoking while taking NRT, the
cigarette would be less satisfying and the person less likely to resume. Hence, NRT also
provide a coping mechanism, making cigarettes less rewarding to smoke.
Pharmacokinetics
Absorption:
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Nicotine is a weak base with a p K a of 8.0. In its ionized state, such as in acidic
environments, nicotine does not rapidly cross membranes. Nicotine from the chewing gum
is released slowly and depends on the intensity of chewing. This nicotine is buffered to
alkaline pH in the oral mucosa to facilitate absorption. Concentrations of nicotine in the
blood rise gradually and plateau at about 30 minutes, with levels persisting and declining
slowly over the next 2 hours. This slow increase in blood and, especially, brain levels
results in low abuse liability of the gum. The absolute dose of nicotine absorbed
systemically from nicotine gum is much less than the nicotine content of the gum, because
some amount of nicotine is swallowed with subsequent first-pass metabolism. Nicotine is
poorly absorbed from the stomach because it is ionized in the acidic gastric fluid. The
bioavailability of nicotine from the gum ranges between 55–78%.
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RESEARCH METHODOLOGY
RESEARCH DESIGN
The following research is Descriptive Research which is based on facts and figures.
This project is done according to the “descriptive research design.”
A research design is a framework or a blue print for conducting the market research
project. It details the procedures necessary for obtaining the information needed for
obtaining the information needed to structure or solve a marketing research problem.
- Exploratory research
- Conclusive research
Conclusive research is typically more formal and structured than exploratory research. It
is based on large representative samples and that data obtained are subjected to a
quantitative analysis. The findings from this research are considered to be conclusive in
nature in that they are used as input into marginal decision making.
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SAMPLING DESIGN
Rarely will be a marketing research project involves examining the entire population i.e.
relevant to the problem,In considering the sampling design there are three things-
1.Patients survey-
Sample size
The total sample size was 200.
Research period
Research was conducted in the month of June.
2. Retailers survey
Sample size
The total sample size was 200.
Research period
Research was conducted in the month of July.
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DATA COLLECTION METHOD
Data was selected from the New Delhi region database for the period of 5 th june to 20th
june for Patients Survey and 27th june to 20th july for Retailers Survey.
For Patients Survey I fill the questionnaires of 10-15 smokers having 8 questions per day.
For Retailers Survey I fill the questionnaires of 8-10 retailers having 6 questions per day.
Data Collection
Mainly Primary data was used in my research and a bit of secondary data for
understanding the background of my research.
Primary Data: Two types of primary data, i.e. Questionnaire method and
Interview method was used in the survey. Primary data are generally information
gathered or generated by the researcher for the purpose of the project immediately at
hand.
The data for the analysis was collected through direct interview of the prospects’. This
method Involves asking prospects and extracting the proper information in terms of
written responses.
I visited 5-6 customers a day, and few of them filled the questionnaires also.
Secondary Data: Data, documents, records, or specimens that have been collected, are in
existence prior to the beginning of the study. It had information about our product and its
terms and also details about the other competitor companies of our product existing in the
same market. This information was extracted from facts and figures already there, from
magazines, internet, journals etc.
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QUESTIONNAIRE
Having defined the sample size and the type of data to be collected, the next step is to
develop the questionnaire and deciding on what all elements will be included in it. The
design of the questionnaire can have as much influence over the response rate as the
method of completion.
The questionnaire prepared for the patients survey comprised of 8 questions and 6
questions for retailers survey. The questionnaire included both open as well as close
ended questions.
DATA ANALYSIS
The data were initially analyzed in the excel sheet with the help of Microsoft Office
Excel 2003. The results were then presented in the form of different types of charts;
column charts, bar charts & pie charts.
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DATA ANALYSIS OF THE PROJECT IN NEW DELHI
(PATIENTS SURVEY)
80
70
60
50
NO. OF
40
SMOKERS
30 SMOKERS
20
10
0
15-20 20-25 25-30 30-35 35-40 40+
AGE GROUPS
Peoples of age groups between 25-30yrs smoke more as compared to other age groups
120
100
80
NO. OF
60
SMOKERS
SMOKERS
40
20
0
5 6-30 31-60 60+
TIME (IN MIN)
Smokers like to smoke every 60min after their first cigarette, where frequent
smokers are very less in no. who would like to smoke every 5 min.
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2. When asked do they find it difficult to refrain from smoking in public places
42%
YES
NO
58%
The no. of smokers who find difficult to smoke in public places is not very high.
About 42% said ‘yes’ and 58% said ‘no’.
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CIGARETTE DIFFICULT TO GIVE UP
10%
90%
57
CIGARETTES PER DAY
160
140
120
100
NO. OF
80
SMOKERS
60
40
20
0
>10 11-20 21-30 30+
NO. OF CIGARETTES
People who smoke less than 10 cigarettes per day is maximum, whereas 30+
cigarettes per day smokers is nil
7%
YES
NO
93%
About 93% smokers said yes who would like to smoke during the first hour. This
means most the smokers are addicted to regular dosage of nicotine
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6. when asked do they smoke when they are ill
28%
YES
NO
72%
Most of the smokers still want to smoke even when they are ill.
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HOW LONG THEY ARE SMOKING
140
120
100
NO. OF 80
SMOKERS 60
40
20
0
TIME(IN >1 >5 >10 >15
YEARS)
TIME(IN YEARS)
People who smoke from less than 5 years seems to be maximum as compared to
other
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DO THEY WANT TO QUIT
46%
YES
NO
54%
The numbers of respondents who doesn’t want to quit smoking is more as compared to the
respondents who want to quit.
RETAILERS SURVEY
1. Do they smoke
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RESPONDENTS WHO SMOKE
12%
YES
NO
88%
NICOGUM
19%
CHEMPIX NICOTEX
3% NULIFE
NULIFE CHEMPIX
9% NICOGUM
NICOTEX
69%
NICOTEX (69%) is the highest selling and most preference brand whereas
very few buy
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3. when asked whether patients come directly and ask for any medicine
NO
2%
YES
NO
YES
98%
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NO. OF PATIENTS BUY NRT REGULARLY
200
150
100
50
0
>5 >10 >15 >20
NO. OF PATIENTS
The no. of patients are very less who buy NRT regularly. There are less than 5
or 10 peoples who come to buy NRT
NO
12%
YES
NO
YES
88%
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Most of the chemists want to get associated in efforts of making quit smoking
LIMITATIONS
Though every effort was put in to make this report authentic in every respect, there
were few uncontrollable factors that might have had their influence on the final
report. The various limiting factors are-:
While making this report few typing and compilation result may have crept in
which have not been able to get rectified. Also the major part of the data
collect is primary in nature and hence the data may be subject to some human
errors.
Since the basic objective of the project is to find out the role of Nicotine
Replacement Therapy NRT to quit smoking. The smokers and retailers
perception and compare it with that of the project standards, it involved
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collection of the information that is confidential from the point of view of
interviewee. Thus some individuals were tentative in giving such kind of
information. This has rendered minor impact on the conclusion of the report.
The study was mainly conducted in the national capital region of Delhi. It has
not have included relevant respondents in other areas in the sample size.
Most of the Questionnaire are poorly filled.
Some of the options are left out
Some of the respondent just tick marked all ranking questions.
Some of the respondents gave same ranks to all the ranking questions.
Some of the respondents are not willing to fill the questionnaire so they just filled it
without knowing the answers.
CONCLUSION
All of the commercially available forms of NRT (gum, transdermal patch, nasal spray,
inhaler and sublingual tablets/lozenges) can help people who make a quit attempt to increase
their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50-
70%, regardless of setting. Peoples of age groups between 25-30yrs smoke more as
compared to other age groups. Smokers like to smoke every 60min after their first cigarette,
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where frequent smokers are very less in no. who would like to smoke every 5 min. Most of
the smokers still want to smoke even when they are ill.
The no. of smokers who find difficult to smoke in public places is not very high. About 90%
smokers find it difficult to give up their 1st cigarette. People who smoke less than 10
cigarettes per day is maximum. About 93% smokers said yes who would like to smoke
during the first hour. This means most of the smokers are addicted to regular dosage of
nicotine.People who smoke from less than 5 years seems to be maximum as compared to
other.The numbers of smokers who doesn’t want to quit smoking is maximum as compared
to the one who want to quit.Most of the retailers are found to be non smokers. NICOTEX
(69%) is the highest selling and most preference brand whereas very few buy
NICOGUM(19%) and CHEMPIX and NULIFE loose preference.Maximum patients come
directly to buy nicotine replacement therapy.
The no. of patients are very less who buy NRT regularly. There are less than 5 or 10 peoples
who come to buy NRT.Most of the chemists want to get associated in efforts of making quit
smoking
We hope this Research Report will help readers understand the harmful effects of tobacco
use and identify best practices for the prevention and treatment of tobacco addiction.
67
RECOMMENDATIONS
68
• the continuing introduction and implementation of tobacco-control policies will
accelerate, further encouraging people to stop smoking, in turn increasing the use of
smoking cessation products
• regular training and advice should be conducted for the retailers whenever there is a
negative feedback or report
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REFERENCES
Books
Website Referred
• www.cipla.com
• Smoke-Free Families (www.smokefreefamilies.org)
• Treating Tobacco Use and Dependence
• Agency for Healthcare Research and Quality (www.ahrq.gov)
• www.wikipidea.com
Search engine
• www.google.com
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APPENDIX (QUESTIONAIRES)
PATIENTS SURVEY
NAME-
AGE-
ADDRESS-
MOBILE NO.-
1. How soon after you wake up you smoke your first cigarette?
2. Do you find it difficult to refrain from smoking in places where it is forbidden, e.g. in
church, at the library, in a cinema, in temple, etc.?
a) Yes b) No
5. Do you smoke more frequently during the first hours after awakening than during the
rest of the day?
a) Yes b) No
6. Do you smoke if you are so ill that you are in bed most of the day?
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a) Yes b) No
a) Yes b) No
RETAILERS SURVEY
6. Do you smoke?
a) Yes b) No
7. Which is the highest selling brand for Nicotine Replacement Therapy (NRT)?
a) Nicotex c) Chempix
b) Nulife d) Nicogum
8. Do patients come directly and ask for any medicine to quit smoking?
a) Yes b) No
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a) Less than 5 c) Less than 15
a) Yes b) No
If any
_____________________________________________________
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