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Pharmaceutical

Polymers for
Liquid and
Semisolid
Dosage Forms
Outline

• Carbopol® and Pemulen™ Polymers, Noveon® Polycarbophil

• Polymer functionality

• Commercial products – dosage forms / administration routes

3 ©2022
© 2022 The Lubrizol Corporation.
Overview - Carbopol® and
Pemulen™ Polymers,
Noveon® Polycarbophil
Lubrizol Pharmaceutical Polymers

Monomer:
CH2CH (COOH)
R = C10–30H21-61
MW = 72

Homopolymers Copolymers

Product Types Description


Carbomer Homopolymers Polymers of acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol

Carbomer Copolymers Polymers of acrylic acid and a C10 – C30 alkyl acrylate crosslinked with allyl
pentaerythritol
Carbomer Interpolymers Carbomer homopolymers or copolymers that contain a block copolymer of
polyethylene glycol and a long chain alkyl acid ester

Polycarbophil Polymer of acrylic acid crosslinked with divinyl glycol

5 ©2022
© 2022 The Lubrizol Corporation.
Lubrizol Pharmaceutical Polymers

Carbopol® Polymers Pemulen™ Polymers Noveon® Polycarbophil

Homopolymers Copolymers Polycarbophil


71G NF TR-1 NF AA-1 USP
971P NF TR-2 NF
974P NF

934P NF 934 NF
940 NF 941 NF
980 NF
981 NF Polymerization Solvents
5984 EP
Ethyl Acetate
Copolymer
1342 NF
Cosolvent Mixture of Ethyl
Interpolymers Acetate and Cyclohexane
ETD 2020 NF
Ultrez 10 NF
Benzene

6 ©2022
© 2022 The Lubrizol Corporation.
Choice of Polymer: Alternative Grades

Benzene Grade Carbopol® Polymer Recommended Non-Benzene Carbopol® Polymers or


Pemulen™ Polymers
Carbopol® 934 NF polymer Carbopol® 5984 EP, 980 NF, ETD 2020 NF and Ultrez 10 NF
polymers
Carbopol® 934P NF polymer Carbopol® 974P NF polymer
Carbopol® 940 NF polymer Carbopol® 980 NF and Ultrez 10 NF polymers
Carbopol® 941 NF polymer Carbopol® 971P NF and 981 NF polymers
Carbopol® 1342 NF polymer Pemulen™ TR-1 and TR-2 NF polymers

• Substitute products are polymerized in either ethyl acetate or a cosolvent mixture of ethyl
acetate and cyclohexane
• Key performance properties should be determined, and full regulatory considerations
should be observed when a substitution is made in a pharmaceutical formulation
• Depending on the desired dosage requirements, other Carbopol® polymers may be
suitable alternatives

7 ©2022
© 2022 The Lubrizol Corporation.
Product Type and Regulatory Status
Pharmacopoeia Monograph Route of
Compendial Name Administration

Carbopol® Residual Europe Japan


Polymer Type Crosslinker United States (USP/NF) Oral Topical
Polymers Solvent (Ph. Eur.) (JPE)1

971P NF Ethyl acetate Homopolymer APE Carbomer Homopolymer Type A Carbomers2 Carboxyvinyl Polymer ⚫ ⚫

71G NF Ethyl acetate Homopolymer APE Carbomer Homopolymer Type A Carbomers2 Carboxyvinyl Polymer ⚫ ⚫

974P NF Ethyl acetate Homopolymer APE Carbomer Homopolymer Type B Carbomers2 Carboxyvinyl Polymer ⚫ ⚫

5984 EP Cosolvent3 Homopolymer AS Carbomer Homopolymer Type B Carbomers2 Carboxyvinyl Polymer ⚫

980 NF Cosolvent Homopolymer APE Carbomer Homopolymer Type C Carbomers2 Carboxyvinyl Polymer ⚫

981 NF Cosolvent Homopolymer APE Carbomer Homopolymer Type A Carbomers2 Carboxyvinyl Polymer ⚫

Ultrez 10 NF Cosolvent Interpolymer AS Carbomer Interpolymer Type A ⚫

ETD 2020 NF Cosolvent Interpolymer APE Carbomer Interpolymer Type B ⚫

934 NF4 Benzene Homopolymer AS Carbomer 934 Carboxyvinyl Polymer ⚫

934P NF Benzene Homopolymer AS Carbomer 934P Carboxyvinyl Polymer ⚫ ⚫

940 NF Benzene Homopolymer APE Carbomer 940 Carboxyvinyl Polymer ⚫

941 NF Benzene Homopolymer APE Carbomer 941 Carboxyvinyl Polymer ⚫

1342 NF Benzene Copolymer APE Carbomer 1342 Carboxyvinyl Polymer ⚫

1 Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph. APE = Allyl ethers of pentaerythritol
2 The Carbomers Monograph in the European Pharmacopeia stipulates that benzene is limited to 2 ppm. AS = Allyl ethers of sucrose
3 Cosolvent is a mixture of ethyl acetate and cyclohexane.

4 Carbopol® 934 NF, 934P NF, 940 NF, 941 NF and 1342 NF polymers are not recommended for new product development due to regulatory restrictions on benzene.

8 ©2022
© 2022 The Lubrizol Corporation.
Product Type and Regulatory Status (Cont’d)

Pharmacopoeia Monograph Route of


Compendial Name Administration

Europe
Residual United States Japan
Polymers Polymer Type Crosslinker (Ph. Oral Topical
Solvent (USP/NF) (JPE)
Eur.)
Pemulen™ Polymers
Carbomer Copolymer
TR-1 NF Cosolvent Copolymer APE ⚫
Type B
Carbomer Copolymer
TR-2 NF Cosolvent Copolymer APE ⚫
Type A
Noveon® Polycarbophil
Ethyl
AA-1 USP Homopolymer DVG Polycarbophil ⚫ ⚫
Acetate

APE = Allyl ethers of pentaerythritol


DVG = Divinyl Glycol

9 ©2022
© 2022 The Lubrizol Corporation.
Carbopol® Polymers – Characteristics

Carbopol® Polymer Carbopol® 71G NF Polymer


Characteristics
(powders) (granular)
Description White, light, fluffy, acidic, White, free flowing, hygroscopic granules
hygroscopic powders

Particle size Flocculated powders have a Typical size range (min 85%) is 150 - 425
median diameter of 5 to 15 microns (sieve analysis)
microns.
Particle morphology Fine particles Mostly large solid chunks with clinging fines
(SEM)

Bulk density (g/cm3) ~0.2 0.325 - 0.400


Tapped density (g/cm3) ~0.3 0.400 - 0.465

10 ©2022
© 2022 The Lubrizol Corporation.
Carbopol® Polymers – Characteristics

Characteristics Carbopol® Polymers


The polymers are not soluble due to their crosslinked nature and high molecular weight.
Solubility/swelling properties The polymers swell in water and some polar solvents (neutralization may be required in
some systems), producing viscous dispersions
Equivalent weight 76 ± 4

Dissociation constant pKa = 6.0 ± 0.5

Chemically very stable under normal storage conditions; no significant changes of the
Chemical stability
chemical parameters or detected impurities for a period of minimum 5 years
Physical stability The polymers are hygroscopic
Equilibrium moisture content
8 - 10% w/w
(25 °C and 50% RH)

Glass transition temperature ~105°C. Glass transition temperature significantly decreases in the presence of moisture

Thermally stable under normal conditions. When exposed to excessive temperatures,


above the glass transition temperature, the polymers become sintered. The products
Thermal stability
may become discolored depending on the temperature and exposure time. Complete
decomposition occurs within 30 minutes when heated at 260°C

Recommended storage In airtight containers, protected from moisture and excessive temperature

11 ©2022
© 2022 The Lubrizol Corporation.
Supply Position for Pharmaceutical Grade
Products

cGMP
Manufacturing Calvert City, KY (U.S.) Antwerp (Kallo), Belgium
Locations
Solvent - Benzene - Cosolvent
Platforms - Ethyl Acetate
- Cosolvent

Products - Carbopol® Polymers - Select Carbopol® Polymers


Produced - Pemulen™ Polymers - Select Pemulen™ Polymers
- Noveon® AA-1 Polycarbophil

Products are offered through a global supply network of direct sales and distributors

12 ©2022
© 2022 The Lubrizol Corporation.
Typical Polymer
Usage Levels
Usage Level
Application
(wt. %)

Topical aqueous gel 0.5 – 3.0

Topical hydroalcoholic gel 0.5 – 3.0

Topical emulsions 0.2 – 0.4

Oral suspension / solution 0.2 – 1.0

13 ©2022
© 2022 The Lubrizol Corporation.
Polymer Functionality
Thickening with a Wide Range
of Flow Properties
Carbopol® Polymers - Swelling

Dry Hydrated Neutralized


Polymer Polymer Polymer

 = 5 - 15µm pH = 3.0 pH = 7.0

16 ©2022
© 2022 The Lubrizol Corporation.
Carbopol® Polymers Swelling Mechanism

18 ©2022
© 2022 The Lubrizol Corporation.
Effect of Polymer Type and Concentration on
the Viscosity at pH 5.0 – Topical Products

120000

Brookfield viscosity @ 20 rpm (mPa*s)


980 NF
100000 Ultrez 10 NF
ETD 2020 NF
80000 5984 EP

60000

40000

20000

0
0 0.5 1 1.5 2 2.5
concentration (%)

pH achieved by addition of NaOH 18% solution

34 ©2022
© 2022 The Lubrizol Corporation.
Effect of Polymer Type and Concentration on
the Viscosity of Dispersions as Prepared

7500

Brookfield viscosity @ 20 rpm (mPa*s)


971P NF
974P NF
6000
980 NF
Ultrez 10 NF
4500 ETD 2020 NF
5984 EP

3000

1500

0
0 0.5 1 1.5 2 2.5
concentration (%)

Viscosity of Carbopol® Ultrez 10 NF and ETD 2020NF polymers is low before neutralization
35 ©2022
© 2022 The Lubrizol Corporation.
Viscosity of Carbopol® Polymer Dispersions –
Hydrogen Bonding

• Carbopol® polymers may form hydrogen bonds


with co-excipients that are hydroxyl donors.
C C
C
• Recommended when it is not feasible to increase OH
C HO C C
the pH of the formulation or in anhydrous C
C C
systems.
C HO
C C C
• Slow process - taking up to several hours; C C
O
heating (up to 60°C) may accelerate it. C C C
OH
C C
C
O
Hydroxyl donors: C C
C
C C C
• Polyols (glycerine, propylene glycol and polyethylene
C
glycol)
• Sugar alcohols (mannitol, sorbitol)
• Some nonionic surfactants
• Polyethylene oxide

36 ©2022
© 2022 The Lubrizol Corporation.
Suspension Stabilization
Carbopol® Polymer Suspending Ability vs.
Xanthan Gum

Aqueous gel with 6 Aqueous gel with 0.6


wt.% xanthan gum wt.% Carbopol® Polymer

Carbopol® polymer gel is able to suspend both spheres of different density

53 ©2022
© 2022 The Lubrizol Corporation.
Suspension Stabilization

• Carbopol® polymers swell when hydrated and


neutralized, forming a colloidal dispersion.

• The swollen, close-packed microgels are able


to hold solid particles within the gel structure
– permanent suspension.

• The suspending ability is due to high yield


value rather than viscosity.

• Carbopol® polymers provide a wide range of


viscosity profiles and have very high yield Suspended Microgel
particle (Carbopol®
values, even at low concentrations. polymer)

54 ©2022
© 2022 The Lubrizol Corporation.
Emulsion Stabilization
Pemulen™ Polymers
Emulsion Stabilization – Pemulen™ Polymers

Pemulen™ polymers
• Carbomer copolymers of acrylic acid and a
long chain alkyl methacrylate crosslinked
with allyl ethers of pentaerythritol
• Have small lipophilic portion in addition to a
large hydrophilic portion
• Form O/W emulsions

• Steric and associative stabilization mechanism:


• Hydrophilic portion forms a gel network
around oil droplets
• Hydrophobic portion anchors in the oil phase
Oil droplet PemulenTM polymer

70 ©2022
© 2022 The Lubrizol Corporation.
Emulsion Stabilization – Pemulen™ Polymers

Pemulen™ polymers vs. traditional surfactants


• Generally independent of oil type(s) / HLB values and level of oils – formulation flexibility
• High efficiency: 0.20 - 0.40 wt%. Use minimum amount of Pemulen™ polymers to
achieve emulsion stabilization and, if necessary, adjust viscosity with Carbopol® polymers
• No surfactant required, but it may be combined to achieve smaller droplet size
• Impart viscosity and yield value (suspending properties)
• Shear thinning rheology

Skin electrolytes

Application triggered oil release

71 ©2022
© 2022 The Lubrizol Corporation.
Emulsion Stabilization - Pemulen™ Polymers

Pemulen™ Polymer TR-1 NF TR-2 NF


USP/NF monograph Carbomer Copolymer Carbomer Copolymer
Type B Type A
Typical oil levels Up to 20 - 30% Up to 50%

Typical use level (wt%) 0.20 – 0.40 0.20 – 0.40

pH formulating range 4-8 4-8

Viscosity (mPa*s) pH 7.3 -


7.8
6,500 - 15,500 1,700 - 4,500
0.2 wt% emulsion
10,000 - 26,500 4,500 - 13,500
1.0 wt% dispersion

72 ©2022
© 2022 The Lubrizol Corporation.
Liquid and Semisolid Dosage Forms
Containing Carbomers or Polycarbophil
Liquid and Semisolid Products for Oral or
Peroral Administration
Trademark
Product Active Inactive Ingredients as Identified on Product Packaging
Owner
Clarithromycin Carbomer, castor oil, citric acid, hypromellose phthalate, maltodextrin,
Biaxin® Granules 125 mg/5 ml/- Abbvie Inc. potassium sorbate, povidone, silicon dioxide, sucrose, xanthan gum, titanium
250 mg/5 ml dioxide and fruit punch flavor.
Boehringer
Nevirapine Ingelheim Carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate
VIRAMUNE® Oral Suspension
50 mg/5 ml Pharmaceuticals, 80, sodium hydroxide and purified water.
Inc.
Carbomer 974, Citronensäure 1H2O, Hypromellose, Natriumcitrat H2O-frei,
Simethicone Parke-Davis/Pfizer Natriumbenzoat, Natriumcyclamat, Macrogolstearylether, Saccharin-Natrium,
Sab simplex® Suspension
69.19 mg/1 ml Pharma Sorbinsäure, Himbeeraroma 60373 H & R, Vanille-Aroma 200817, gereinigtes
Wasser.
Sodium alginate
1 g/10 ml Calciumcarbonat, Carbomer 974P, Methyl-4-hydroxybenzoat (E 218), Propyl-4-
Gaviscon® Advance
Potassium Reckitt Benckiser hydroxybenzoat (E 216), Saccharin-Natrium, Pfefferminz-Aroma,
Pfefferminz Suspension
bicarbonate Natriumhydroxid, ger. Wasser.
0.2 g/10 ml
Hymetellose, Carbomer 974, Natriumhydroxid, Glycerol, Methyl-4-
Nystatin
Lederlind® Mundgel RIEMSER hydroxybenzoat, Propyl-4-hydroxybenzoat, Natriumcalciumedetat, Orangenaroma,
22.73 mg/g
gereinigtes Wasser.
Lidocaine
hydrochloride Aromastoffe, natürlich, naturidentisch; Dinatrium edetat; Wasser,
Kamistad®-Gel
20 mg/g Chamomile STADA gereinigtes; Carbomer; Acesulfam
STADA
flowers extract kalium; Propylenglycol; Sorbitol; Trometamol; Ethanol; Glycerol
185 mg/g

GlaxoSmithKline wasserfreies Natriummonohydrogenphosphat, Carbomer 956,


Sensodyne® PROSCHMELZ Sodium fluoride
Consumer Natriumdodecylsulfat, Himbeeraroma, Pfefferminzaroma, Grapefruitaroma,
Fluorid Gelée Dental gel 2.765 g/100 g
Healthcare Saccharin-Natrium, Natriumhydroxid, Patentblau V (E 131), gereinigtes Wasser.

111 ©2022
© 2022 The Lubrizol Corporation.
Liquid and Semisolid Products for
Ophthalmic Administration
Trademark
Product Active Inactive Ingredients as Identified on Product Packaging
Owner
Sun 0.003% benzalkonium chloride, mannitol, citric acid, Polycarbophil,
AzaSite® (azithromycin Azithromycin
Pharmaceutical sodium citrate, poloxamer 407, edetate disodium (EDTA), sodium
1%) 1%
Industries, Inc. chloride, water for injection, and sodium hydroxide to pH 6.3.
benzalkonium chloride 0.01%, Polycarbophil, mannitol, poloxamer 407,
sodium chloride, edetate disodium dihydrate, sodium hydroxide and water for
Besivance® suspension Besifloxacin 0.6% (6ml/ml) Bausch and Lomb injection.
Besivance is an isotonic suspension with an osmolality of approximately 290
mOsm/kg
Boric acid, edetate disodium dihydrate, glycerin, Polycarbophil, propylene
Lotemax® Gel Loteprednol Etabonate 5
Bausch and Lomb glycol, sodium chloride, tyloxapol, water for injection, and sodium hydroxide
mg/g (0.5%)
to adjust to a pH of between 6 and 7, benzalkonium chloride 0.003%.
Sodium hyaluronate
Hylan® Augentropfen Pharma Stulln Carbomer 981, Glycerol, gereinigtes Wasser.
0.15 mg/ml
0.01% benzalkonium chloride, mannitol, Carbomer 974P, tyloxapol,
AZOPT® (brinzolamide Brinzolamide
Alcon edetate disodium, sodium chloride, hydrochloric acid and/ or sodium
1%) 10 mg/ml
hydroxide (to adjust pH), and purified water.
0.01% benzalkonium chloride, sorbitol ( Ph.Eur. ), Carbomer 980,
Predni-POS® 1% Prednisolone acetate
Ursapharm sodium acetate trihydrate, sodium hydroxide (to adjust pH), and purified
Augentropfen suspension 10 mg/g
water.
Mannitol, poly(styrene-divinyl benzene) sulfonic acid, Carbomer 974P,
boric acid, N-lauroylsarcosine, edetate disodium, hydrochloric acid or
Betaxon™ Ophthalmic Levobetaxolol
Alcon Labs USA tromethamine (to adjust pH) and purified water. It has a pH of 5.5 to 7.5
Suspension hydrochloride 0.5%
and an osmolality of 260 to 340 mOsm per kg, benzalkonium chloride
0.01%
Benzalkonium chloride 0.01%, Mannitol, Poly(Styrene-Divinyl Benzene)
Betoptic S® Ophthalmic sulfonic acid, Carbomer 934P, edetate disodium, hydrochloric acid or sodium
Betaxolol hydrochloride
Suspension Novartis hydroxide (to adjust pH) and purified water. BETOPTIC S® (betaxolol
0.25%
hydrochloride ophthalmic suspension) 0.25% has a pH of approximately 7.6
112 ©2022
© 2022 The Lubrizol Corporation. and an osmolality of approximately 290 mOsmol/kg
Liquid and Semisolid Products for
Ophthalmic Administration
Trademark
Product Active Inactive Ingredients as Identified on Product Packaging
Owner
Boric acid, propylene glycol, carbomer 974P, sodium chloride, guar gum,
Ilevro® Ophthalmic
Nepafenac carboxymethylcellulose sodium, edetate disodium, benzalkonium chloride
Suspension Novartis
0.3% 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust
pH and purified water, USP.

Ganciclovir Carbomer 974P, Sorbitol, Natriumhydroxid, Benzalkoniumchlorid,


Virgan® Augengel Théa Pharma
1.5 mg/g gereinigtes Wasser.

Benzalkonium chloride 0.01%, carbomer 974P, polysorbate 80, sodium


Vexol® 1% Ophthalmic
Rimexolone 10 mg (1%) Alcon Labs USA chloride, edetate disodium, sodium hydroxide and/or hydrochloric acid (to
Suspension
adjust pH) and purified water.
benzalkonium chloride, mannitol (Ph.Eur.), Carbomer, polysorbate 80,
Vexol® 1% Augentropfen Rimexolone sodium edetate (Ph.Eur.), Sodium chloride, purified water. Smallest
Alcon
suspension 10 mg/ml amounts of hydrochloric acid or sodium hydroxide can be added to adjust
the pH.

Fucithalmic® Fusidic Acid 0.01% w/w benzalkonium chloride, disodium edetate, mannitol, Carbomer,
Fusidic acid 1% (10mg/g). Leo Pharma
Eye drops sodium hydroxide, water for injection

Dexpanthenol Bausch and Cetrimide, Carbomer, Disodium edetat, Sodium hydroxide, Water for
Corneregel® Augengel
50 mg/g Lomb injections

RESTASIS® Ophthalmic Cyclosporine Glycerin, castor oil, polysorbate 80, Carbomer copolymer type A,
Allergan, Inc.
Emulsion 0.05% purified water and sodium hydroxide to adjust the pH.

113 ©2022
© 2022 The Lubrizol Corporation.
Liquid and Semisolid Products for
Ophthalmic Administration

Trademark
Product Active Inactive Ingredients as Identified on Product Packaging
Owner

GenTeal® Tears Severe Hypromellose 2910 (4000 Mpa.S), Carbopol 980*, GenAqua (sodium
Novartis
Hypromellose gel perborate), phosphonic acid, purified water, sodium hydroxide, and sorbitol.

Carbomer 980, Cetrimide, sorbitol, medium-chain triglycerides, sodium


Liposic® Ophthalmic Gel Bausch and Lomb
hydroxide (for pH adjustment) and purified water
Carbopol 980, Hypromellose 2910 (4000 Mpa.S), phosphonic acid, purified
Systane® Gel Alcon Labs USA water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust
pH
Carbomer (polyacrylic acid), Cetrimide (as a preservative), sorbitol,
Viscotears® Liquid Gel Novartis
sodium hydroxide and water.

Boric acid; carbomer copolymer type A; Carboxymethylcellulose sodium;


Refresh Optive® drops Allergan Glycerin; Polysorbate 80; castor oil; erythritol; levocarnitine; purified water;
Purite® (stabilized oxychloro complex) and sodium hydroxide

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© 2022 The Lubrizol Corporation.
Liquid and Semisolid Products for
Mucosal Administration
Product Active Trademark Owner Inactive Ingredients as Identified on Product Packaging

Natriumbenzoat (E 211), Kaliummetabisulfit (E 224) (entspr. max.


Mesalamine
Claversal® Rectal Suspension Merckle Recordati 0,16 g SO2 ), Carbomer 934, Natriumedetat, Kaliumacetat,
4 g/60 g
Xanthangummi, ger. Wasser

Cetylstearylalkohol, selbstemulgierendes Glycerolmonostearat


Vagi-Metro® Creme Vaginal Metronidazole (Tegin), Isopropylmyristat, Natriumhydroxid, Macrogol-20-
Drossapharm
creme 5 g/ 100 g glycerolmonostearat, Propylenglycol, Carbomer 34000 mPaS,
Gereinigtes Wasser, konserviert mit Chlorphenesin

Sorbinsäure 0,9 mg, Glycerol, dünnflüssiges Paraffin, hydriertes


Progesterone
Crinone® 8% Vaginal gel Serono Palmölglycerid, Carbomer 974P, Polycarbophil, Natriumhydroxid,
90 mg/1.125 g (8% w/w)
gereinigtes Wasser

Dr. August Wolff Wasser, Cetylstearylalkohol, Poly(oxyethylen)-20-


Estriol
Estriol Wolff® Vaginal Cream Arzneimittel GmbH & Co. glycerolmonostearat, Glycerolmonostearat, Isopropylmyristat,
0.5 mg/1g
KG Carbomer, 2-Phenoxyethanol, Natriumhydroxid

Product Active Trademark Owner Inactive Ingredients as Identified on Product Packaging

Purified Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer


ReplensTM Vaginal Moisturizer Church&Dwight Homopolymer type B, Hydrogenated palm oil,
glyceride, methylparaben, sorbic acid, sodium hydroxide

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Liquid and Semisolid Products for
Skin Administration
Product Active Trademark owner Inactive ingredients as Identified on Product Packaging

Betamethasone
Betnesol®-V crinale
valerate GlaxoSmithKline Carbomer 980, 2-Propanol, Natriumhydroxid, gereinigtes Wasser
0,1%
1.22 mg/g

Carbomer 941, Benzylalkohol, Glycerol, Macrogol 400, Macrogolstearylether-21,


Metronidazole Macrogolglycerolstearate, Stearylalkohol, dünnflüssiges Paraffin, Cyclomethicon,
Metrolotion® Emulsion Galderma
7.5 mg/g Kaliumsorbat, Milchsäure- u./od. Natriumhydroxid-Lsg. (zur pH-Wert-Einstell.), ger.
Wasser

Carbomer 980, Natriumedetat, Natriumhydroxid, Dodecylpoly(oxyethylen)-2-


Benzoyl peroxide
Aknefug® Oxid Wash Wolff hydrogensulfat-Natriumsalz, α-Stearoyl-ω-stearoyloxypoly(oxyethylen)-3, gereinigtes
4 g/100 g
Wasser.
Carbomer (40.000–60.000 cP), Dimeticon (350 cSt), Emulgierender
Hydrocortisone
Ebenol® leicht 0,25% Cetylstearylalkohol (Typ A) (Ph.Eur.), Gereinigtes Wasser, Glycerol 85%,
acetate Strathmann
Crème Glycerolmonostearat, Kaliumsorbat (Ph.Eur.), Mittelkettige Triglyceride, Natriumedetat
0.25 g/100 g
(Ph.Eur.), Octyldodecanol (Ph.Eur.), Trometamol, [(Z)-Octadec-9-en1-yl]oleat.
Diclofenac Carbomer 974P, Octan-/Decansäurefettalkoholester, Cetomacrogol 1000, N-
Voltaren® Emulgel®
diethylamine Novartis Ethylethanamin, 2-Propanol, dickfl. Paraffin, Parfumcreme, Propylenglycol, gereinigtes
Gel
1.16 g/100 g Wasser.

Estradiol
Divigel® Gel Orion Corporation Carbomer, ethanol, propylene glycol, purified water, and triethanolamine.
0.1%

Lidocaine 25 mg Macrogolglycerol hydroxystearate, Carbomer 974P, sodium hydroxide and purified


EMLA® Cream AstraZeneca
Prilocaine 25 mg water

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Liquid and Semisolid Products for
Skin Administration
Product Active Trademark owner Inactive ingredients as Identified on Product Packaging
Calcipotriene
Isopropyl myristate, mineral oil, medium-chain triglyceride, isopropyl alcohol, polyoxyl
50 mcg/g
lauryl ether, poloxamer (407), polyoxyl 40 hydrogenated castor oil, carbomer
WYNZORA® Cream Betamethasone MC2 Therapeutics
interpolymer type A, butylated hydroxy anisole, trolamine, dibasic sodium phosphate,
Dipropionate
monobasic sodium phosphate, DL-A-tocopherol and purified water
0.644 mg/g
carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone,
Soolantra® Topical Ivermectin edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol,
Galderma Labs LP
Cream 1% phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben,
purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.
Testosterone Drug reservoir contains alcohol USP, glycerin USP, glycerol monooleate, methyl laurate,
Androderm®
2mg/24hr, Allergan, Inc. sodium hydroxide NF, to adjust pH, and purified water USP, gelled with carbomer
Transdermal Patch
4mg/24h copolymer Type B NF
Clobex® Generic,
Clobetasol Propylene glycol, water, hypromelloses, carbomer copolymer type B (allyl
Clobetasol Propionate Teligent, Inc.
Propionate 0.05% pentaerythritol crosslinked), mineral oil, sodium hydroxide, polyethylene glycol 300
topical lotion
benzyl alcohol 1%, carbomer homopolymer type B; carbomer 1342, edetate
Tazarotene
Tazorac® Cream Allergan, Inc disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulfate,
0.1%
sorbitan monooleate, and sodium hydroxide to adjust pH
Testosterone
Carbomer homopolymer type c, diisopropyl adipate, ethanol, carbomer
Vogelxo™ Transdermal 50 mg/5 g Upsher-Smith
copolymer type b, propylene glycol, polyethylene glycol, oleyl alcohol, methyl laurate,
Gel packet,12.5 mg Laboratories Inc.
tris, glycerol, purified water
/1.25 g actuation
benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen
Tretinoin TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben,
Altreno® Topical Lotion Dow Pharma
0.05% mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and
trolamine
Halobetasol
propionate carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate,
DUOBRII® Topical
0.01%, Bausch edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified
Lotion
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Corporation. water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%
0.045%
Conclusions

Lubrizol pharmaceutical polymers provide key benefits in liquid and semisolid dosage forms
• Versatile and efficient
• Provide rheology modification for aqueous, anhydrous and hydroalcoholic systems
at low usage levels
• Compatible with most acidic, basic and neutral drugs
• Applications across a broad pH range (4.5 – 10.0)
• No heat sensitivity compared to other thickening agents
• Multi-functional
• Highly efficient thickening, emulsion and suspension stabilization
• Can increase bioavailability of active pharmaceutical ingredients due to their
bioadhesive properties
• Safety and quality
• Demonstrated to have low irritancy and non-sensitizing properties
• Manufactured under cGMP conditions
• Consistent and reproducible properties due to their synthetic nature
• Do not support microbial growth

118 ©2022
© 2022 The Lubrizol Corporation.
Thank You
For more information, samples and/or
starting formulations with complete
processing instructions and supplier
references please contact:

Lubrizol Advanced Materials, Inc.


9911 Brecksville Road
Cleveland, Oh 44141
800-379-5389
216-447-5000
www.lubrizol.com/Life-Science
Disclaimer
The information contained herein is being furnished for informational purposes only, upon the express condition that the User makes its own
assessment of the appropriate use of such information. While the information contained herein is believed to be reliable, no representations,
guarantees or warranties of any kind are made as to its accuracy, suitability for a particular application or the results to be obtained herefrom.
Lubrizol Advanced Materials, Inc. ("Lubrizol") cannot guarantee how any products associated with this information will perform in combination with
other substances or in User’s process. Due to the variations in methods, conditions and equipment used commercially in processing these materials,
no warranties or guarantees are made as to the suitability of the information/products for the applications disclosed. Lubrizol shall not be liable and
the User assumes all risk and responsibility for, any use or handling of any material beyond Lubrizol's direct control. LUBRIZOL MAKES NO
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. It is the User’s sole responsibility to determine if there are any issues relating to patent infringement of any component or
combination of components relating to the supplied information. Nothing contained herein is to be considered as permission, recommendation, nor as
an inducement to practice any patented invention without the permission of the patent owner.

© Copyright 2022 Lubrizol Advanced Materials, Inc.

120 ©2022
© 2022 The Lubrizol Corporation.

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