ACTIVE
PHARMACEUTICAL
INGREDIENTS
“CARVEDILOL”
VINOTHARAN NAIR(1000024)
SANGIDHA JAGATHEESAN(1000013 )
CONTENTS
 Introduction
 History
 Structure of Carvedilol
 Properties of Carvedilol
 Uses of Carvedilol
 How its‟s wo...
INTRODUCTION
Carvedilol also known as Coreg
Used commonly in the treatment of CHF
or Congestive Heart failure or high bl...
HISTORY
Carvedilol was discovered by Robert R.
Ruffolo
The discovery and development of
carvedilol encountered an advers...
 Robert R Ruffolo was President of Research and
Development for Wyeth Pharmaceuticals, and
corporate Senior Vice Presiden...
STRUCTURE OF “CARVEDILOL”

2D view

3D view
 The trade name of Carvedilol is known as Coreg
 This tablet is oval in shape and white colored
 It contains differing ...
PROPERTIES OF “CARVEDILOL”
These active pharmaceutical ingredients can
be dissolved in water, intestinal fluids or
gastri...
USES OF “CARVEDILOL”
Carvedilol is used for treating high blood
pressure and congestive heart failure.
It is also used a...
HOW IT WORKS ??
Most norepinephrine reactants will activate
nerve endings, which control heart muscle
movements
Carvedil...
WHY “CARVEDILOL” IS PREFERRED??
Carvedilol does not worsen existing heart
failure symptoms like some other drugs do
Comp...
COMMON SIDE EFFECTS:
The most common side effects include:
Dizziness
Fatigue
Hypotension
Diarrhea
Weight gain
SIDE EFFECTS IF YOU DISCONTINUE THE
CONSUMPTION OF „CARVEDILOL‟
Sharp chest pain
Irregular heartbeat
Sometimes heart at...
MANUFACTURING PROCESS OF
“CARVEDILOL”
The manufacture of products based on small molecule Active Pharmaceutical Ingredien...
SIFTING
Sift Carvedilol through , Lactose
monohydrate and Ferric Oxide
through the above sifted Carvedilol
and Lactose mo...
DRY MIXING
Load the above sifted material in Rapid mixer
granulator and mix for 10 minutes with
impeller slow speed.

GRA...
DRYING
Air dry the wet mass for 10 minutes and
dry at inlet temperature to reach NMT
80°C, dry the granules till loss on ...
SIFTING AND MILLING
Sift the dried granules and mill
retentions through multimill using 1mm
screen at medium speed and kn...
BLENDING AND LUBRICATION
 Mix the materials of dried granules with Silica
Colloidal Anhydrous in Octagonal Blender for
15...
THE PROCESS
FLOWCHART
RAPID MIXER GRANULATOR
SHE Consideration
SAFETY CONSIDERATION
 Reduce direct skin contact, reduce exposure via
inhalation; and minimize the possibility of chemica...
HEALTH CONSIDERATION
Hazardous exposure to workers may occur
through inhalation of dust created during:
hand manipulation...
PRICE ASPECT OF THIS PROCESS
 Chronic heart failure (CHF) is now recognized as a
major and escalating public health probl...
MARKET DEMAND VS. SUPPLY
 Manufacture and market Carvedilol Tablets, 3.125
mg, 6.25 mg, 12.5, and 25 mg. The Office of Ge...
REFERENCES
http://eurjhf.oxfordjournals.org/content/ 3/3/283.full
http://www.goodrx.com/coreg/price
http://www.aafp.org/af...
API Ingredients
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API Ingredients

  1. 1. ACTIVE PHARMACEUTICAL INGREDIENTS “CARVEDILOL” VINOTHARAN NAIR(1000024) SANGIDHA JAGATHEESAN(1000013 )
  2. 2. CONTENTS  Introduction  History  Structure of Carvedilol  Properties of Carvedilol  Uses of Carvedilol  How its‟s works ??  Why Carvedilol is preferred ??  Common Side Effects  Manufacturing Process  SHE Considerations  Price aspect  Market Demand Vs. Supply
  3. 3. INTRODUCTION Carvedilol also known as Coreg Used commonly in the treatment of CHF or Congestive Heart failure or high blood pressure Carvedilol is a nonselective beta blocker/alpha-1 blocker indicated in the treatment of mild to severe congestive heart failure (CHF)
  4. 4. HISTORY Carvedilol was discovered by Robert R. Ruffolo The discovery and development of carvedilol encountered an adverse regulatory climate, skepticism by the cardiology community and hesitance by the company, and in the early 1990s The fate of the drug was uncertain
  5. 5.  Robert R Ruffolo was President of Research and Development for Wyeth Pharmaceuticals, and corporate Senior Vice President of Wyeth from 2001 to 2008 Robert R Ruffolo
  6. 6. STRUCTURE OF “CARVEDILOL” 2D view 3D view
  7. 7.  The trade name of Carvedilol is known as Coreg  This tablet is oval in shape and white colored  It contains differing concentrations of Carvedilol namely in 3.125, 6.25, 12.5 and 25 m dosages.  Molecular Formula: C 24 H 26 N 2 O 4 Carvedilol in tablet form
  8. 8. PROPERTIES OF “CARVEDILOL” These active pharmaceutical ingredients can be dissolved in water, intestinal fluids or gastric fluids Carvedilol should be taken with food
  9. 9. USES OF “CARVEDILOL” Carvedilol is used for treating high blood pressure and congestive heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well To treat a certain type of irregular heartbeat Carvedilol also helps to relax blood vessels, reduces the need for oxygen in the body, and helping the heart beat more regularly and efficiently
  10. 10. HOW IT WORKS ?? Most norepinephrine reactants will activate nerve endings, which control heart muscle movements Carvedilol drug works by blocking the binding of the norepinephrine to these receptors  This way, the heart rhythm slows down and the pumping force of the heart muscles is also reduced
  11. 11. WHY “CARVEDILOL” IS PREFERRED?? Carvedilol does not worsen existing heart failure symptoms like some other drugs do Compared to other drugs, which work in a similar fashion, Carvedilol does not have much inotropic effects or inverse agonist effects However, there is no scientific evidence to support the fact that Carvedilol is more preferred compared to other beta blocking drugs
  12. 12. COMMON SIDE EFFECTS: The most common side effects include: Dizziness Fatigue Hypotension Diarrhea Weight gain
  13. 13. SIDE EFFECTS IF YOU DISCONTINUE THE CONSUMPTION OF „CARVEDILOL‟ Sharp chest pain Irregular heartbeat Sometimes heart attack
  14. 14. MANUFACTURING PROCESS OF “CARVEDILOL” The manufacture of products based on small molecule Active Pharmaceutical Ingredients (API) remains critical to global healthcare  The manufacturing landscape is also full of challenges and opportunities This is due to emerging international markets and rapidly evolving social, economic, regulatory and environmental expectations
  15. 15. SIFTING Sift Carvedilol through , Lactose monohydrate and Ferric Oxide through the above sifted Carvedilol and Lactose monohydrate it is sifted with Ferric Oxide through Lactose monohydrate and Microcrystalline Cellulose.
  16. 16. DRY MIXING Load the above sifted material in Rapid mixer granulator and mix for 10 minutes with impeller slow speed. GRANULATING  Add binder solution over dry mix material in a period of 10 minutes at impeller slow speed and mix the content in Rapid Mixer Granulator at impeller slow speed.
  17. 17. DRYING Air dry the wet mass for 10 minutes and dry at inlet temperature to reach NMT 80°C, dry the granules till loss on drying reaches to not more than 105°C.
  18. 18. SIFTING AND MILLING Sift the dried granules and mill retentions through multimill using 1mm screen at medium speed and knives forward configuration. Sifting of extra granular Materials; Sift Silica Colloidal Anhydrous and Magnesium Stearate.
  19. 19. BLENDING AND LUBRICATION  Mix the materials of dried granules with Silica Colloidal Anhydrous in Octagonal Blender for 15 minutes. Add Magnesium Stearate to the above materials in Octagonal Blender for 5 minutes.
  20. 20. THE PROCESS FLOWCHART
  21. 21. RAPID MIXER GRANULATOR
  22. 22. SHE Consideration
  23. 23. SAFETY CONSIDERATION  Reduce direct skin contact, reduce exposure via inhalation; and minimize the possibility of chemicals being brought home on workers‟ clothing  As with all potentially hazardous exposures, protective measures should include: engineering controls (e.g., barriers and containments, laboratory hoods, glove boxes, and worker isolation);  Administrative controls; personal protective equipment (e.g., respirators, gloves and lab coats)  Training
  24. 24. HEALTH CONSIDERATION Hazardous exposure to workers may occur through inhalation of dust created during: hand manipulation operation of a tablet encapsulation machine by performing sieving and granulation operations
  25. 25. PRICE ASPECT OF THIS PROCESS  Chronic heart failure (CHF) is now recognized as a major and escalating public health problem.  The costs of this syndrome, both in economic and personal terms, are considerable.  The prevalence of CHF is 1–2% and appears to be increasing, in part because of ageing of the population.  60 tablets of carvedilol of 25mg would be $4.00
  26. 26. MARKET DEMAND VS. SUPPLY  Manufacture and market Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Coreg® Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, respectively.  Total annual market sales for Carvedilol Tablets were $1.6 billion (IMS – MAT: June 2007).
  27. 27. REFERENCES http://eurjhf.oxfordjournals.org/content/ 3/3/283.full http://www.goodrx.com/coreg/price http://www.aafp.org/afp/1998/1101/p1627.html http://www.ranbaxy.com/ranbaxy -gains-us-fda-approval-tomanufacture-and-market-carvedilol-tablets-in-the-us-market  http://en.wikipedia.org/wiki/Norepinephrine /    
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