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GREEN CHEMISTRY IN
PHARMACEUTICAL INDUSTRY
GREEN CHEMISTRY IN PHARMACEUTICAL INDUSTRY
DEEPALI*, ARTI KORI, URMI CHAURASIA
Department of Pharmaceutical Science, Sardar Bhagwan Singh Post Graduate Institute of Biomedical Science &
Research, Balawala Dehradun,Uttarakhand- 248161
INTRODUCTION
Green chemistry is an innovative
technique involving design of chemical
products and processes to eliminate
generation of hazardous sustances.
Development of pharmaceutical
products by use of green chemistry can
result in reduction of waste generation,
minimize energy consumption and It can
play an important role to eliminate
health related issues due to use of
organic solvents or process resulting
environmental waste generation.
GREEN PHARMACY
Green pharmacy seeks to eliminate
unnecessary enviromental impact,
but we must enable delivery of life
saving medicines and also show
value for our stakeholders.
Green pharmacy principles do not
condemn this but rather encourage
that these goals be met through our
absolute best performance. Minimum
Pharmaceutical
Waste
Design
Pharmaceutical
Products for
Degradation
Green
Biocatalysis For
Pharmaceutical
Industry
Designing
Safer
Chemicals
and
Solvents
New
Development
In Degradable
& Recycled
Polymers
PRINCIPLE
BARRIERS IN THE PHARMACEUTICAL
INDUSTRY
SHORT
DEVELOPMENT
CYCLE
LIMITED PATENT
LIFE
PRODUCT
QUALITY
REGUATORY
REQUIREMENT
LACK OF
UNIFIED
METRICS
HIGH COST OF
DEVELOPMENT
HIGH PROJECT
ATTRITION
ADVANTAGES OF GREEN CHMISTRY IN
PHARMA INDUSTRY
NON TOXIC
SELF
REGENERATING
NO SOLVENTS OR
BINDERS USED
CATALYTIC
TRANSFERS
ENERGYFROM
LIGHT
100% EFFICIENT
(EPA ) APPROVED
INGREDIENTS
GREENING UP DRUGS
GREENER SYNTHETIC PATHWAY OF SERTRALINE
In 2002,
Pfizer
SERTRALINE
NEW
SYNTHESIS
PATHWAY
1 SINGLE
STEP
PROCESS
ALL STEPS
PREFORM
BY
ETHANOL
OLD
PROCESS
SERTRALINE
SYNTHESIS
3-STEP
SEQUENCE
PROCESS
METHYLENE
CHLORIDE
TOLUENE
HEXANE
TETRA
HYDROFURAN
Ethanol eliminates the distillation & recovery of four
toxic solvent in the synthesis improves the efficiency
and selectivity of the synthesis.
In 2004, BMS
New
approach to
Paclitaxel
API in the
anticancer
drug Taxol
The
sustainable
process by
BMS using
latest
biotechnology
technique
Synthesizing
Paclitaxel
from a
precursor &
extracted
from plant
cell cultures
&
manufacture.
• Reduces the amount of waste.
• Making new process a more cost- effective option.
• Eliminate all organic solvents, hazardous reagents.
10-deacetylbaccatin
III (10-DAB)
11-step synthesis PaclitaxelTaxol
OLD ROUTE
NEW ROUTE
GREENER SYNTHETIC PATHWAY
New
Synthesis of
Sitagliptin
Greener
Synthetic
Pathway
In
2006,
Merck
GREENER PATHWAY OF SITAGLIPTIN
CONVENTIONAL
SOLVENTS
FLAMMABLE
CORROSIVE
TOXIC
AIR, WATER &
LAND POLLUTION
INCREASE THE
RISK OF
WORKERS,
EXPOSURE & LED
SERIOUS
ACCIDENTS
RECOVERY &
REUSE POSSIBLE
BUT CROSS-
CONTAMINATION
OCCURS
SOLVENTS
Solvents define a major portion of the
environmental performance of a process and also
influence safety and health issues.
Green solvents such as water, liquid polymers,
ionic liquids, bio-ethanol, supercritical fluids and
ethyl lactate hold considerable additional promises.
SAFEER
SOLUTION
SOLVENTSLESS
SYSTEM
WATER
SUPERCRITICAL
FLUIDS
(SCF)
IONIC
LIQUIDS
SOLVENT
WATER
• Water is universal solvent.
• It is safe, improved reaction rates & does not pose any hazards.
• It can be useful solvent for large scale process.
• It improve Diels-Alder reaction in water.
SCF
• SCF are substances have been simultaneously heated and compressed above their critical
point.
• Examples of SCF- Methane, methanol, ethanol or acetone.
• scCarbon dioxide is versatile solvent, safe & easy to handle.
• It is widely used in industrial application- decaffeination of green coffee beans replacement of
perchloroethylene in dry cleaning.
• Hydrogenation, epoxidation, radical reactions, Palladium-mediated C-C bond formation, ring
closing metathesis, biotransformation, polymerization and many others reactions can be
performed with scCO2 as a reaction medium.
IONIC FLUID
• Ionic liquids, new area of solvent are attractive because of their negligible vapor pressure.
• They use in polar systems to generate new chemistries.
• Plethora of ionic liquids can be produced by varying the cations and anions, permitting the
synthesis of ionic liquids tailored for specific application.
• They are two types- (i) salt (ii) binary ionic liquid
GREEN CONTINUOUS FLOW SYNTHESIS OF IBUPROFEN
McQuade APPROACH
• In 2009, McQuade group describe 3
step approach towards Ibuprofen
micro reactor technology.
• The synthesis of ibuprofen in only
ten minutes residence time through
the yield of only 51% equating to a
productivity of 9 mg/min.
JAMISON APPROACH
• Jamison laboratory reported on an improved flow
synthesis of the ibuprofen sodium salt.
• It delivers the target compound in only 3 minutes
residence time with an improved productivity of about
135 mg/min.
1 2
3
4
Ibuprofen
APPLICATIONS
• Green chemistry is being employed to develop
revolutionary drug delivery methods they are
more effective and less toxic and could benefit
millions of patients.
• Green chemistry method produces no waste,
reaction is a quick one-step reaction and a very
little amount of catalyst is utilized.
• Improved process conditions and economics,
incorporating green chemistry into the synthesis
of active pharmaceutical ingredients (APIs) and
intermediates is of ongoing importance to the
pharmaceutical industry.
• Solvent reduction and replacement and
biocatalysis are some of the tools used to
optimize select API syntheses.
• GlaxoSmithKline (GSK, London) developed the
“Eco-Design Toolkit” as a way to provide
bench-level chemists and engineers with access
to green-chemistry information and tools for
process research and development and
manufacture.
• Green chemistry help to improved healthcare &
reduced environment footprint.
CONCLUSION
• The growth of green chemistry over the
course of the past decade needs to increase at
an accelerated pace if pharmaceutical science
is to meet the challenges of sustainability.
• By using green chemistry procedures, we can
minimize the waste of materials, maintain the
atom economy and prevent the use of
hazardous chemicals. Researchers and
pharmaceutical companies need to be
encouraged to consider the principles of green
chemistry while designing the processes and
choosing reagents.
REFERENCES
• Tucker, J.L., 2006. Green chemistry, a pharmaceutical perspective. Organic process
research & development, 10(2), pp.315-319.
• Valavanidis, A., 2012. Green Chemistry and New Technological Developments. New
Avenues for the Green Economy and Sustainable Future of Science and Technology.
• Anastas, P. and Eghbali, N., 2010. Green chemistry: principles and practice. Chemical
Society Reviews, 39(1), pp.301-312.
• Anastas, P.T. and Kirchhoff, M.M., 2002. Origins, current status, and future
challenges of green chemistry. Accounts of chemical research, 35(9), pp.686-694.
• Baumann, M. and Baxendale, I.R., 2015. The synthesis of active pharmaceutical
ingredients (APIs) using continuous flow chemistry. Beilstein journal of organic
chemistry, 11, p.1194.
• Talaviya, S. and Majmudar, F., 2012. Green chemistry: A tool in Pharmaceutical
Chemistry. NHL Journal of Medical Sciences, 1(1), pp.7-13.

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Green Chemistry in Pharmaceutical Industry

  • 2. GREEN CHEMISTRY IN PHARMACEUTICAL INDUSTRY DEEPALI*, ARTI KORI, URMI CHAURASIA Department of Pharmaceutical Science, Sardar Bhagwan Singh Post Graduate Institute of Biomedical Science & Research, Balawala Dehradun,Uttarakhand- 248161 INTRODUCTION Green chemistry is an innovative technique involving design of chemical products and processes to eliminate generation of hazardous sustances. Development of pharmaceutical products by use of green chemistry can result in reduction of waste generation, minimize energy consumption and It can play an important role to eliminate health related issues due to use of organic solvents or process resulting environmental waste generation.
  • 3. GREEN PHARMACY Green pharmacy seeks to eliminate unnecessary enviromental impact, but we must enable delivery of life saving medicines and also show value for our stakeholders. Green pharmacy principles do not condemn this but rather encourage that these goals be met through our absolute best performance. Minimum Pharmaceutical Waste Design Pharmaceutical Products for Degradation Green Biocatalysis For Pharmaceutical Industry Designing Safer Chemicals and Solvents New Development In Degradable & Recycled Polymers PRINCIPLE
  • 4. BARRIERS IN THE PHARMACEUTICAL INDUSTRY SHORT DEVELOPMENT CYCLE LIMITED PATENT LIFE PRODUCT QUALITY REGUATORY REQUIREMENT LACK OF UNIFIED METRICS HIGH COST OF DEVELOPMENT HIGH PROJECT ATTRITION ADVANTAGES OF GREEN CHMISTRY IN PHARMA INDUSTRY NON TOXIC SELF REGENERATING NO SOLVENTS OR BINDERS USED CATALYTIC TRANSFERS ENERGYFROM LIGHT 100% EFFICIENT (EPA ) APPROVED INGREDIENTS
  • 6. GREENER SYNTHETIC PATHWAY OF SERTRALINE In 2002, Pfizer SERTRALINE NEW SYNTHESIS PATHWAY 1 SINGLE STEP PROCESS ALL STEPS PREFORM BY ETHANOL OLD PROCESS SERTRALINE SYNTHESIS 3-STEP SEQUENCE PROCESS METHYLENE CHLORIDE TOLUENE HEXANE TETRA HYDROFURAN Ethanol eliminates the distillation & recovery of four toxic solvent in the synthesis improves the efficiency and selectivity of the synthesis.
  • 7. In 2004, BMS New approach to Paclitaxel API in the anticancer drug Taxol The sustainable process by BMS using latest biotechnology technique Synthesizing Paclitaxel from a precursor & extracted from plant cell cultures & manufacture. • Reduces the amount of waste. • Making new process a more cost- effective option. • Eliminate all organic solvents, hazardous reagents. 10-deacetylbaccatin III (10-DAB) 11-step synthesis PaclitaxelTaxol OLD ROUTE NEW ROUTE GREENER SYNTHETIC PATHWAY
  • 9. CONVENTIONAL SOLVENTS FLAMMABLE CORROSIVE TOXIC AIR, WATER & LAND POLLUTION INCREASE THE RISK OF WORKERS, EXPOSURE & LED SERIOUS ACCIDENTS RECOVERY & REUSE POSSIBLE BUT CROSS- CONTAMINATION OCCURS SOLVENTS Solvents define a major portion of the environmental performance of a process and also influence safety and health issues. Green solvents such as water, liquid polymers, ionic liquids, bio-ethanol, supercritical fluids and ethyl lactate hold considerable additional promises. SAFEER SOLUTION SOLVENTSLESS SYSTEM WATER SUPERCRITICAL FLUIDS (SCF) IONIC LIQUIDS SOLVENT
  • 10. WATER • Water is universal solvent. • It is safe, improved reaction rates & does not pose any hazards. • It can be useful solvent for large scale process. • It improve Diels-Alder reaction in water. SCF • SCF are substances have been simultaneously heated and compressed above their critical point. • Examples of SCF- Methane, methanol, ethanol or acetone. • scCarbon dioxide is versatile solvent, safe & easy to handle. • It is widely used in industrial application- decaffeination of green coffee beans replacement of perchloroethylene in dry cleaning. • Hydrogenation, epoxidation, radical reactions, Palladium-mediated C-C bond formation, ring closing metathesis, biotransformation, polymerization and many others reactions can be performed with scCO2 as a reaction medium. IONIC FLUID • Ionic liquids, new area of solvent are attractive because of their negligible vapor pressure. • They use in polar systems to generate new chemistries. • Plethora of ionic liquids can be produced by varying the cations and anions, permitting the synthesis of ionic liquids tailored for specific application. • They are two types- (i) salt (ii) binary ionic liquid
  • 11. GREEN CONTINUOUS FLOW SYNTHESIS OF IBUPROFEN McQuade APPROACH • In 2009, McQuade group describe 3 step approach towards Ibuprofen micro reactor technology. • The synthesis of ibuprofen in only ten minutes residence time through the yield of only 51% equating to a productivity of 9 mg/min. JAMISON APPROACH • Jamison laboratory reported on an improved flow synthesis of the ibuprofen sodium salt. • It delivers the target compound in only 3 minutes residence time with an improved productivity of about 135 mg/min. 1 2 3 4 Ibuprofen
  • 12. APPLICATIONS • Green chemistry is being employed to develop revolutionary drug delivery methods they are more effective and less toxic and could benefit millions of patients. • Green chemistry method produces no waste, reaction is a quick one-step reaction and a very little amount of catalyst is utilized. • Improved process conditions and economics, incorporating green chemistry into the synthesis of active pharmaceutical ingredients (APIs) and intermediates is of ongoing importance to the pharmaceutical industry. • Solvent reduction and replacement and biocatalysis are some of the tools used to optimize select API syntheses. • GlaxoSmithKline (GSK, London) developed the “Eco-Design Toolkit” as a way to provide bench-level chemists and engineers with access to green-chemistry information and tools for process research and development and manufacture. • Green chemistry help to improved healthcare & reduced environment footprint. CONCLUSION • The growth of green chemistry over the course of the past decade needs to increase at an accelerated pace if pharmaceutical science is to meet the challenges of sustainability. • By using green chemistry procedures, we can minimize the waste of materials, maintain the atom economy and prevent the use of hazardous chemicals. Researchers and pharmaceutical companies need to be encouraged to consider the principles of green chemistry while designing the processes and choosing reagents.
  • 13. REFERENCES • Tucker, J.L., 2006. Green chemistry, a pharmaceutical perspective. Organic process research & development, 10(2), pp.315-319. • Valavanidis, A., 2012. Green Chemistry and New Technological Developments. New Avenues for the Green Economy and Sustainable Future of Science and Technology. • Anastas, P. and Eghbali, N., 2010. Green chemistry: principles and practice. Chemical Society Reviews, 39(1), pp.301-312. • Anastas, P.T. and Kirchhoff, M.M., 2002. Origins, current status, and future challenges of green chemistry. Accounts of chemical research, 35(9), pp.686-694. • Baumann, M. and Baxendale, I.R., 2015. The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry. Beilstein journal of organic chemistry, 11, p.1194. • Talaviya, S. and Majmudar, F., 2012. Green chemistry: A tool in Pharmaceutical Chemistry. NHL Journal of Medical Sciences, 1(1), pp.7-13.