API Ingredients
Download as PPTX, PDF0 likes1,016 views
This document provides information about the active pharmaceutical ingredient carvedilol. It discusses the history, structure, properties, uses, manufacturing process, safety and environmental considerations, pricing, and market demand for carvedilol. Carvedilol was discovered by Robert Ruffolo and is commonly used to treat congestive heart failure and high blood pressure by blocking norepinephrine receptors in the heart. Common side effects include dizziness, fatigue, and diarrhea. The manufacturing process involves steps like sifting, mixing, granulating, drying, milling and blending. Safety measures are needed to reduce worker exposure during production.
API Ingredients
- 1. ACTIVE PHARMACEUTICAL INGREDIENTS “CARVEDILOL” VINOTHARAN NAIR(1000024) SANGIDHA JAGATHEESAN(1000013 )
- 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. 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. 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. 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. STRUCTURE OF “CARVEDILOL” 2D view 3D view
- 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. PROPERTIES OF “CARVEDILOL” These active pharmaceutical ingredients can be dissolved in water, intestinal fluids or gastric fluids Carvedilol should be taken with food
- 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. 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. 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. COMMON SIDE EFFECTS: The most common side effects include: Dizziness Fatigue Hypotension Diarrhea Weight gain
- 13. SIDE EFFECTS IF YOU DISCONTINUE THE CONSUMPTION OF „CARVEDILOL‟ Sharp chest pain Irregular heartbeat Sometimes heart attack
- 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. 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. 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. 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. 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. 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.
- 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. 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. 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. 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).
- 28. 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 /