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An Overview: PEG & Poloxamer 
Presented By: Mayur N. Pandya 
14MPH114 
M.Pharm Sem-1 
IPNU 
Guided By: Dr. Tejal A. Mehta 
HOD 
Dept. of Pharmaceutics 
IPNU
CONTENTS 
PEG 
Introduction 
Characteristics 
Manufacturing Method 
Merit & Demerits 
Functional Category 
Applications 
Poloxamer 
Introduction 
Characteristics 
Manufacturing Method 
Functional Category 
Biological Effects 
Applications
Poly Ethylene Glycol(PEG)
 Introduction 
• PEG (Poly Ethylene Glycol) is most used excipient 
as polymer for Formulations in Pharmaceutical field. 
• PEG is a polyether compound with many 
applications from industrial manufacturing to 
medicine. 
• The ability of PEG to influence the pharmacokinetic 
properties of drugs and drug carriers is currently 
utilized in a wide variety of established and 
emerging applications in pharmaceutics.
• PEG is also known as polyethylene oxide 
(PEO) or polyoxyethylene (POE), depending 
on its molecular weight. 
• The Structure of PEG is H-(O-CH2-CH2)n-OH 
here n indicates number of EO(polyethylene 
units). 
• Generally, variable PEG Commercial grades 
denoted its molecular weight. 
E.g. PEG 400 
PEG 800 
PEG 200
• Nonproprietry Names 
BP: Macrogols 
JP: Macrogol 400 
Macrogol 1500 
Macrogol 4000 
Macrogol 6000 
Macrogol 20000 
PhEur: Macrogols 
USP-NF: Polyethylene Glycol 
• Chemical Name 
 α-Hydro-o-hydroxypoly(oxy-1,2-ethanediyl)
• Synonyms 
Carbowax 
 Carbowax Sentry 
Lipoxol 
Lutrol E 
Macrogola 
Pluriol E 
• Structural Formula
 Manufacturing Method 
• In Pharmaceutical industry, PEGs are manufactured 
by polymerization of ethylene oxide(EO) with either 
water, mono ethylene glycol or diethylene glycol as 
starting material, under alkaline catalysis. 
• After the desired molecular weight is reached 
(usually checked by viscosity measurements as in-process 
control) the reaction is terminated by 
neutralizing the catalyst with acid. 
• Normally lactic acid is used, but also acetic acid or 
others can be found.
 Characteristics 
• Appearance 
 Polyethylene glycol grades 200–600 are liquids grades 1000 
and above are solids at ambient temperatures. PEG 600 can 
occur as a solid at ambient temperatures. 
 Solid grades (PEG>1000) are white or off-white in color, and 
range in consistency from pastes to waxy flakes. They have a 
faint, sweet odor. Grades of PEG 6000 and above are 
available as freeflowing milled powders. 
 Liquid grades (PEG 200–600) occur as clear, colorless or 
slightly yellow-colored, viscous liquids. They have a slight but 
characteristic odor and a bitter, slightly burning taste.
• Moisture Content 
Liquid polyethylene glycols are very hygroscopic, 
although hygroscopicity decreases with increasing 
molecular weight. Solid grades, e.g. PEG 4000 and 
above, are not hygroscopic. 
• Surface Tension 
Approximately 44 dynes/cm (44mN/m) for liquid 
polyethylene glycols. 
Approximately 55 dynes/cm (55mN/m) for 10% w/v 
aqueous solution of solid polyethylene glycol.
• Solubility 
All grades of polyethylene glycol are soluble in water 
and miscible in all proportions with other polyethylene 
glycols(after melting, if necessary). 
Aqueous solutions of higher molecular-weight grades 
may form gels. Liquid polyethylene glycols are soluble in 
acetone, alcohols, benzene, glycerin, and glycols. 
Solid polyethylene glycols are soluble in acetone, 
dichloromethane, ethanol (95%), and methanol; they are 
slightlysoluble in aliphatic hydrocarbons and ether, but 
insoluble in fats,fixed oils, and mineral oil. 
• Density 
1.11–1.14 g/cm3 at 25°C for liquid PEGs. 
1.15–1.21 g/cm3 at 25°C for solid PEGs.
• Flash Point 
182°C for PEG 200 
213°C for PEG 300 
238°C for PEG 400 
250°C for PEG 600 
• Melting Point 
37–40°C for PEG 1000 
44–48°C for PEG 1500 
55–63°C for PEG 6000 
60–63°C for PEG 8000 
60–63°C for PEG 20000
• Stability 
Polyethylene glycols are chemically stable in air and in 
solution, although grades with a molecular weight less 
than 2000 are hygroscopic. Polyethylene glycols do not 
support microbial growth, and they do not become 
rancid. 
Polyethylene glycols and aqueous polyethylene glycol 
solutions can be sterilized by autoclaving, filtration, or 
gamma irradiation. 
• Storage 
 Polyethylene glycols should be stored in well-closed 
containers in a cool, dry place. Stainless steel, 
aluminum, glass, or lined steel containers are preferred 
for the storage of liquid grade
 Merits 
• Polyethylene glycols are stable, hydrophilic substances 
that are essentially nonirritant to the skin. 
• Polyethylene glycols are water-soluble and are easily 
removed from the skin by washing, making them useful 
as ointment bases. 
• Mixtures of polyethylene glycols can be used as 
suppository bases for which they have many advantages 
over fats. For example, the melting point of the 
suppository can be made higher towithstand exposure to 
warmer climates. 
• The physical stability on storage is Better. 
• Suppositories are readily miscible with rectal fluids.
 Demerits 
• They are chemically more reactive than fats 
greater care is needed in processing to avoid 
inelegant contraction holes in the suppositories 
• The rate of release of water-soluble medications 
decreases with the increasing molecular weight 
of the polyethylene glycol 
• Polyethylene glycols tend to be more irritating to 
mucous membranes than fats.
 Functional Category 
• Ointment Base 
• Plasticizer 
• Solvent 
• Suppository Base 
• Tablet 
• Capsule Lubricant
 Applications 
• Polyethylene glycols (PEGs) are widely used in 
a variety of pharmaceutical formulations, 
including parenteral, topical, ophthalmic, oral, 
and rectal preparations. 
• Polyethylene glycol has been used 
experimentally in biodegradable polymeric 
matrices used in controlled-release systems. 
• Polyethylene glycols have been used in the 
preparation of urethane hydrogels, which are 
used as controlled-release agents.
• PEG grafted with poly(methacrylic acid) have 
been used as bioadhesive controlled drug 
delivery formulations. 
• It can be used alone for the film-coating of 
tablets or can be useful as hydrophilic polishing 
materials. 
• Animal studies have also been performed using 
polyethylene glycols as solvents for steroids in 
osmotic pumps. 
• Polyethylene glycols are useful as plasticizers in 
microencapsulated products to avoid rupture of 
the coating film when the microcapsules are 
compressed into tablets.
POLOXAMER
 INTRODUCTION 
• Poloxamers are Non-ionic triblock co-polymers 
comoposed of a Central hydrophobic chain of 
Polyoxypropylene flanked by two hydrophobic 
chains of polyoxyethylene. 
• Poloxamers are often considered as “Functional 
Excipients” because they are essential 
components and play an important role in the 
Formulation.
• Poloxamers are synthetic triblock Co-polymers 
with the following general structure formula
• Non-proprietary Names 
BP : Poloxamers 
PhEur : Poloxamera 
USPNF : Poloxamer 
• Synonyms 
Lutrol 
Monolan 
Polyethylene Propylene Glycol Copolymer
Commercial Grades 
Non-Proprietry Name Commercial Grades 
Poloxamer 124 L-44 
Poloxamer 184 L-64 
Poloxamer 185 P-65 
Poloxamer 188 F-68 
Poloxamer 237 F-87 
Poloxamer 338 F-108 
Poloxamer 407 F-127
 Characteristics 
The Character of 
each poloxamer in 
terms of : 
Is Determined By 
The Chain Length 
Of the 
Polyethylene (EO) 
Units 
AND 
Polyoxypropylene 
(PO) Units 
Molecular 
Wt. 
Appearance 
Hydrophobici 
ty/Hydrophilici 
ty 
Solubility
• Appearance 
Polxamer 124: Colourless or Almost colourless 
liquid 
Poloxamer 188, 237, 338, 407: White or almost 
white, waxy powder, microbeads 
or flakes. 
• HLB Value: 0.5-30. 
• Flowability: 
Solid Poloxamers are free flowing.
• Solubility 
Poloxamer 124, 237, 338, 407: Very Soluble in 
water and in ethanol (96%), Practically insoluble 
in light petroleum (50-70°C) 
Poloxamer 188: Soluble in Water and in Ethanol 
(96%) 
• pH(Aqueous Solution): 5.0-7.5
• Melting Point 
Non-Proprietry Name Melting Point (°C) 
Poloxamer 124 16 
Poloxamer 188 52-57 
Poloxamer 237 49 
Poloxamer 338 57 
Poloxamer 407 52-57
• Moisture Content 
Poloxamers generally contain less than 0.5% 
w/w water and are Hygro-scopic only at relative 
humidity greater than 80% 
• Density 
1.06 g/cm3 at 25°C 
• Flash Point 
260°C
• Incompatibilities 
Depending on the relative concentrations 
E.g. Poloxamer 188 is Incompatible with 
phenols and parabens. 
• Storage 
Stored in a well closed container in a cool, 
dry place.
 Manufacturing Method 
• Poloxamer polymers are prepared by reacting 
propylene oxide with propylene glycol to form 
polyoxypropylene glycol. 
• Ethylene Oxide is then added to form the block 
co-polymer. 
• All Poloxamer are chemically similar in 
composition, differing only in the relative 
amounts of propylene and ethylene oxides.
 Functional Category 
• Dispersing Agent 
• Emulsifying Agent 
• Solubilizing Agent 
• Tablet Lubricant 
• Wetting Agent
 Biological Effects 
• Researchers have recently shown that some of 
these polymers, originally inert carrier molecules 
have a very real effect on biological systems 
independently of the drug they are transporting 
• The Poloxamers have been shown to 
incorporate cellular membranes affecting the 
microviscosity of the membranes and increase 
drug transportation 
Effect On Multi Drug Resistant Cancer Cells
 Applications 
• Poloxamers are used as emulsifying, solubilizing 
or stabilizing agents to maintain the clarity of 
elixirs and syrups. 
• E.g. Poloxamer 188 used as and emulsifying 
agent for fluorocarbons used as artificial blood 
substitutes and in the preparation of solid-dispersion. 
• Also used as wetting agents in Ointments, 
Suppository bases, and Gels and as tablet 
binders and Coatings.
• Poloxamers may also be used therapeutically as 
Wetting agents in 
Eye-drop Formulations 
In the treatment of Kidney stones 
Skin-wound Cleansers 
• Poloxamer 338 and 407 are used in Solutions for 
contact lens care. 
• E.g. Therapeutically, Poloxamer 188 is administered 
orally as wetting agent and stool lubricant in the 
treatment of Constipation.
• In materials science, the poloxamer P123 has 
recently been used in the synthesis of 
mesoporous materials. 
• Used to increase the water solubility of 
hydrophobic oily substances or otherwise 
increase then miscibility of two substances with 
different hydrophobicities, for these reason used 
in cosmetics and pharmaceuticals. 
• Poloxamer-188 improves heart functioning in a 
rodent model of ischemic heart failure.
 Uses of Poloxamer 
Uses Concentration(%) 
Fat Emulsifier 0.3 
Flavor Solubilizer 0.3 
Fluorocarbon Emulsifier 2.5 
Gelling Agent 15-50 
Spreading Agent 1 
Stabilizing Agent 1-5 
Suppository Base 4-6 
Tablet Coating 10 
Tablet Excipient 5-10 
Wetting Agent 0.05-5
 References 
• International Journal of PharmTech Research; 
Poloxamers; A pharmaceutical excipients with 
therapeutic behaviors; Hitesh R. Patel, Rakesh P. Patel, 
M.M. Patel; Vol.1, No.2, pp 299-303, April-June 2009 
• Handbook of Pharmaceutical excipients; Raymond 
Rowe, Paul Sheskey, Marian Quinn; Sixth edition; pp 
506-512,517-522
An overview peg & poloxamer

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An overview peg & poloxamer

  • 1. An Overview: PEG & Poloxamer Presented By: Mayur N. Pandya 14MPH114 M.Pharm Sem-1 IPNU Guided By: Dr. Tejal A. Mehta HOD Dept. of Pharmaceutics IPNU
  • 2. CONTENTS PEG Introduction Characteristics Manufacturing Method Merit & Demerits Functional Category Applications Poloxamer Introduction Characteristics Manufacturing Method Functional Category Biological Effects Applications
  • 4.  Introduction • PEG (Poly Ethylene Glycol) is most used excipient as polymer for Formulations in Pharmaceutical field. • PEG is a polyether compound with many applications from industrial manufacturing to medicine. • The ability of PEG to influence the pharmacokinetic properties of drugs and drug carriers is currently utilized in a wide variety of established and emerging applications in pharmaceutics.
  • 5. • PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular weight. • The Structure of PEG is H-(O-CH2-CH2)n-OH here n indicates number of EO(polyethylene units). • Generally, variable PEG Commercial grades denoted its molecular weight. E.g. PEG 400 PEG 800 PEG 200
  • 6. • Nonproprietry Names BP: Macrogols JP: Macrogol 400 Macrogol 1500 Macrogol 4000 Macrogol 6000 Macrogol 20000 PhEur: Macrogols USP-NF: Polyethylene Glycol • Chemical Name  α-Hydro-o-hydroxypoly(oxy-1,2-ethanediyl)
  • 7. • Synonyms Carbowax  Carbowax Sentry Lipoxol Lutrol E Macrogola Pluriol E • Structural Formula
  • 8.  Manufacturing Method • In Pharmaceutical industry, PEGs are manufactured by polymerization of ethylene oxide(EO) with either water, mono ethylene glycol or diethylene glycol as starting material, under alkaline catalysis. • After the desired molecular weight is reached (usually checked by viscosity measurements as in-process control) the reaction is terminated by neutralizing the catalyst with acid. • Normally lactic acid is used, but also acetic acid or others can be found.
  • 9.  Characteristics • Appearance  Polyethylene glycol grades 200–600 are liquids grades 1000 and above are solids at ambient temperatures. PEG 600 can occur as a solid at ambient temperatures.  Solid grades (PEG>1000) are white or off-white in color, and range in consistency from pastes to waxy flakes. They have a faint, sweet odor. Grades of PEG 6000 and above are available as freeflowing milled powders.  Liquid grades (PEG 200–600) occur as clear, colorless or slightly yellow-colored, viscous liquids. They have a slight but characteristic odor and a bitter, slightly burning taste.
  • 10. • Moisture Content Liquid polyethylene glycols are very hygroscopic, although hygroscopicity decreases with increasing molecular weight. Solid grades, e.g. PEG 4000 and above, are not hygroscopic. • Surface Tension Approximately 44 dynes/cm (44mN/m) for liquid polyethylene glycols. Approximately 55 dynes/cm (55mN/m) for 10% w/v aqueous solution of solid polyethylene glycol.
  • 11. • Solubility All grades of polyethylene glycol are soluble in water and miscible in all proportions with other polyethylene glycols(after melting, if necessary). Aqueous solutions of higher molecular-weight grades may form gels. Liquid polyethylene glycols are soluble in acetone, alcohols, benzene, glycerin, and glycols. Solid polyethylene glycols are soluble in acetone, dichloromethane, ethanol (95%), and methanol; they are slightlysoluble in aliphatic hydrocarbons and ether, but insoluble in fats,fixed oils, and mineral oil. • Density 1.11–1.14 g/cm3 at 25°C for liquid PEGs. 1.15–1.21 g/cm3 at 25°C for solid PEGs.
  • 12. • Flash Point 182°C for PEG 200 213°C for PEG 300 238°C for PEG 400 250°C for PEG 600 • Melting Point 37–40°C for PEG 1000 44–48°C for PEG 1500 55–63°C for PEG 6000 60–63°C for PEG 8000 60–63°C for PEG 20000
  • 13. • Stability Polyethylene glycols are chemically stable in air and in solution, although grades with a molecular weight less than 2000 are hygroscopic. Polyethylene glycols do not support microbial growth, and they do not become rancid. Polyethylene glycols and aqueous polyethylene glycol solutions can be sterilized by autoclaving, filtration, or gamma irradiation. • Storage  Polyethylene glycols should be stored in well-closed containers in a cool, dry place. Stainless steel, aluminum, glass, or lined steel containers are preferred for the storage of liquid grade
  • 14.  Merits • Polyethylene glycols are stable, hydrophilic substances that are essentially nonirritant to the skin. • Polyethylene glycols are water-soluble and are easily removed from the skin by washing, making them useful as ointment bases. • Mixtures of polyethylene glycols can be used as suppository bases for which they have many advantages over fats. For example, the melting point of the suppository can be made higher towithstand exposure to warmer climates. • The physical stability on storage is Better. • Suppositories are readily miscible with rectal fluids.
  • 15.  Demerits • They are chemically more reactive than fats greater care is needed in processing to avoid inelegant contraction holes in the suppositories • The rate of release of water-soluble medications decreases with the increasing molecular weight of the polyethylene glycol • Polyethylene glycols tend to be more irritating to mucous membranes than fats.
  • 16.  Functional Category • Ointment Base • Plasticizer • Solvent • Suppository Base • Tablet • Capsule Lubricant
  • 17.  Applications • Polyethylene glycols (PEGs) are widely used in a variety of pharmaceutical formulations, including parenteral, topical, ophthalmic, oral, and rectal preparations. • Polyethylene glycol has been used experimentally in biodegradable polymeric matrices used in controlled-release systems. • Polyethylene glycols have been used in the preparation of urethane hydrogels, which are used as controlled-release agents.
  • 18. • PEG grafted with poly(methacrylic acid) have been used as bioadhesive controlled drug delivery formulations. • It can be used alone for the film-coating of tablets or can be useful as hydrophilic polishing materials. • Animal studies have also been performed using polyethylene glycols as solvents for steroids in osmotic pumps. • Polyethylene glycols are useful as plasticizers in microencapsulated products to avoid rupture of the coating film when the microcapsules are compressed into tablets.
  • 20.  INTRODUCTION • Poloxamers are Non-ionic triblock co-polymers comoposed of a Central hydrophobic chain of Polyoxypropylene flanked by two hydrophobic chains of polyoxyethylene. • Poloxamers are often considered as “Functional Excipients” because they are essential components and play an important role in the Formulation.
  • 21. • Poloxamers are synthetic triblock Co-polymers with the following general structure formula
  • 22. • Non-proprietary Names BP : Poloxamers PhEur : Poloxamera USPNF : Poloxamer • Synonyms Lutrol Monolan Polyethylene Propylene Glycol Copolymer
  • 23. Commercial Grades Non-Proprietry Name Commercial Grades Poloxamer 124 L-44 Poloxamer 184 L-64 Poloxamer 185 P-65 Poloxamer 188 F-68 Poloxamer 237 F-87 Poloxamer 338 F-108 Poloxamer 407 F-127
  • 24.  Characteristics The Character of each poloxamer in terms of : Is Determined By The Chain Length Of the Polyethylene (EO) Units AND Polyoxypropylene (PO) Units Molecular Wt. Appearance Hydrophobici ty/Hydrophilici ty Solubility
  • 25. • Appearance Polxamer 124: Colourless or Almost colourless liquid Poloxamer 188, 237, 338, 407: White or almost white, waxy powder, microbeads or flakes. • HLB Value: 0.5-30. • Flowability: Solid Poloxamers are free flowing.
  • 26. • Solubility Poloxamer 124, 237, 338, 407: Very Soluble in water and in ethanol (96%), Practically insoluble in light petroleum (50-70°C) Poloxamer 188: Soluble in Water and in Ethanol (96%) • pH(Aqueous Solution): 5.0-7.5
  • 27. • Melting Point Non-Proprietry Name Melting Point (°C) Poloxamer 124 16 Poloxamer 188 52-57 Poloxamer 237 49 Poloxamer 338 57 Poloxamer 407 52-57
  • 28. • Moisture Content Poloxamers generally contain less than 0.5% w/w water and are Hygro-scopic only at relative humidity greater than 80% • Density 1.06 g/cm3 at 25°C • Flash Point 260°C
  • 29. • Incompatibilities Depending on the relative concentrations E.g. Poloxamer 188 is Incompatible with phenols and parabens. • Storage Stored in a well closed container in a cool, dry place.
  • 30.  Manufacturing Method • Poloxamer polymers are prepared by reacting propylene oxide with propylene glycol to form polyoxypropylene glycol. • Ethylene Oxide is then added to form the block co-polymer. • All Poloxamer are chemically similar in composition, differing only in the relative amounts of propylene and ethylene oxides.
  • 31.  Functional Category • Dispersing Agent • Emulsifying Agent • Solubilizing Agent • Tablet Lubricant • Wetting Agent
  • 32.  Biological Effects • Researchers have recently shown that some of these polymers, originally inert carrier molecules have a very real effect on biological systems independently of the drug they are transporting • The Poloxamers have been shown to incorporate cellular membranes affecting the microviscosity of the membranes and increase drug transportation Effect On Multi Drug Resistant Cancer Cells
  • 33.  Applications • Poloxamers are used as emulsifying, solubilizing or stabilizing agents to maintain the clarity of elixirs and syrups. • E.g. Poloxamer 188 used as and emulsifying agent for fluorocarbons used as artificial blood substitutes and in the preparation of solid-dispersion. • Also used as wetting agents in Ointments, Suppository bases, and Gels and as tablet binders and Coatings.
  • 34. • Poloxamers may also be used therapeutically as Wetting agents in Eye-drop Formulations In the treatment of Kidney stones Skin-wound Cleansers • Poloxamer 338 and 407 are used in Solutions for contact lens care. • E.g. Therapeutically, Poloxamer 188 is administered orally as wetting agent and stool lubricant in the treatment of Constipation.
  • 35. • In materials science, the poloxamer P123 has recently been used in the synthesis of mesoporous materials. • Used to increase the water solubility of hydrophobic oily substances or otherwise increase then miscibility of two substances with different hydrophobicities, for these reason used in cosmetics and pharmaceuticals. • Poloxamer-188 improves heart functioning in a rodent model of ischemic heart failure.
  • 36.  Uses of Poloxamer Uses Concentration(%) Fat Emulsifier 0.3 Flavor Solubilizer 0.3 Fluorocarbon Emulsifier 2.5 Gelling Agent 15-50 Spreading Agent 1 Stabilizing Agent 1-5 Suppository Base 4-6 Tablet Coating 10 Tablet Excipient 5-10 Wetting Agent 0.05-5
  • 37.  References • International Journal of PharmTech Research; Poloxamers; A pharmaceutical excipients with therapeutic behaviors; Hitesh R. Patel, Rakesh P. Patel, M.M. Patel; Vol.1, No.2, pp 299-303, April-June 2009 • Handbook of Pharmaceutical excipients; Raymond Rowe, Paul Sheskey, Marian Quinn; Sixth edition; pp 506-512,517-522