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Carbomers are a family of chemically related, synthetic, high molecular weight, nonlinear polymers of polyacrylic acids cross-linked with a polyalkenyl polyether. They are an important class of pharmaceutical excipient and ingredient in personal care formulations. Different grades can be distinguished by their molecular weight, polymerization solvent or side groups. They are, however, all supplied as white-coloured, fluffy, acidic, hygroscopic powders with a characteristic odour.
Synonyms and Trade Names: Carbomer; Carbomer Type A/B/C; Acrylates/C10-30 Alkyl Acrylate Copolymer; Carbomer Copolymer; Polyacrylic acid; Acrylates/C10-30 Alkyl Acrylate Crospolymer, Acrypol; Acritamer; Acrylic Acid Polymer; Carbopol®; Carboxy Polymethylene; Carboxyvinyl Polymer; Pemulen®; Tego® Carbomer; Acrypol® Carbomer
Pharmacopoeial Compliance: USP-NF; Ph.Eur; JP; IP
Uses and Applications: Thickening Agents; Rheology Modifiers; Bioadhesive Polymers; Controlled-Release Agents; Emulsifying Agents; Stabilizing Agents; Suspending Agents; and Tablet Binders (Matrices)
Carbomers are a group of synthetic, high molecular weight, nonlinear polymers of polyacrylic acids cross-linked with a polyalkenyl polyether. All Carbomers are chemically related to each other, only differing in molecular weight, polymerization solvent or side-groups. The amount of carboxylic acid groups in different Carbomer molecules varies between 56 and 68% w/w.
Originally developed by BF Goodrich and trademarked CARBOPOL® in 1958 (US patent 2798503), Carbomers (Carbopol 940, 941, and 934) revolutionised topical products by enabling formulators to create new types of products previously not possible. Even after several decades, they still remain highly relevant and should be on the shortlist for every new product development project.
Various pharmacopoeias use different approaches in the way they define Carbomers. The Ph.Eur, which is harmonised with the B.P, has a single monograph that covers Carbomer excipients that are official in these compendia. The J.P.E, Ch.P and I.P similarly have single monographs, respectively titled Carboxyvinyl Polymer, Carbomer Homopolymer, and Carbomer.
In the USP-NF, there are multiple monographs for five carbomers, namely Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342, which are polymerised in benzene. In addition, the USP-NF includes three broad monographs, Carbomer copolymer, Carbomer homopolymer, and Carbomer interpolymer which are further split into three products (A, B, C) solely on the basis of viscosity.
Carbomers occur as white-coloured, low bulk density, hygroscopic powders with a perceptible odour of acrylic acid.
Chemical Name | Carbomer |
CAS Registry Number | Several CAS Registry number are used for carbomers:
[9003-01-4] [19007-16-31] [19007-17-41] [19062-04-081] [19007-20-91] |
Molecular Weight | Molecular weight of Carbomers is estimated to be 7×105 to 4×109 Da. |
EC Number | 618-347-7 |
UNII Code (FDA) | 4Q93RCW27E |
Carbomers are approved pharmaceutical excipients and cosmetic ingredients. They are listed in all the main pharmacopoeia, including the USP-NF, Ph.Eur, JPE, IP and Ch.P. Carbomers are also included in the US FDA Inactive Ingredients Database (covering oral suspensions, tablets; ophthalmic, rectal, topical. transdermal preparations; vaginal suppositories).
Physical form | Solid, powder |
Appearance | White, fluffy powders |
pH value (0.2% w/v aqueous dispersion) | 2.5 – 4.0 |
Bulk density | 0.3 g/ml (powder)
0.4 g/ml (granular) |
pKa (Dissociation constant) | 6.0 ±0.5 |
Glass transition temperature | 100 oC – 105 0C |
Melting point | Decomposition occurs within 30 minutes at 2600C |
Moisture content | Carbomers are hygroscopic. Equilibrium moisture content at 25oC and 50% relative humidity is 8 – 10% w/w |
Particle size distribution | Primary particles average about 0.2 µm diameter. Granular carbomer grades has a particle size in the range 150-425 µm |
Solubility | Carbomers swell in water, ethanol, water, propylene glycol and glycerin to form gels |
Relative density | 1.41 |
Viscosity | Carbomers disperse in water to form acidic colloidal dispersions.
When neutralised, viscosity increases significantly to form highly viscous gels. Viscosity values (depend on concentration and grade) but are typically range 100 to 120,000 mPa.s |
USP-NF | PhEur | |
Official name | Carbomer | Carbomer |
Authorised use | Excipient | Excipient |
Definitions | specified | specified |
Identification | specified | Infra red spectrum
Dispersion at pH 7.5 Orange colour with Thymol Blue Viscosity |
Description | White, fluffy hygroscopic powders, swelling in water and other polar solvents | White, fluffy hygroscopic powders, swelling in water and other polar solvents |
Aqueous Viscosity (mPas) | n/a | 300 – 115,000 |
Carbomer 934
934P (0.5% w/v) 940 (0.5% w/v) 941 (0.5% w/v) Carbomer 1342 (1% w/v) Carbomer Copolymer Type A Type B Type C Carbomer Copolymer (1% w/v) Type A Type B Type C Carbomer Interpolymer Type A (0.5% w/v) Type B (1% w/v) Type C (0.5% w/v) Loss on Drying |
30,500 – 39,400
29,400 – 39,400 40,000 – 60,000 4,000 – 11,000 9,500 – 26,500
4,500 – 13,500 10,000 – 29,000 25,000 – 45,000
4,000 – 11,000 25,000 – 45,000 40,000 – 60,000
45,000 – 65,000 47,000 – 77,000 8,500 – 16,500 ≤2.0% |
n/a |
Sulphated Ash | – | ≤4.0% |
Residue on Ignition | ≤4.0% | n/a |
Heavy Metals | ≤0.002% | ≤20ppm |
Benzene | + | ≤2ppm |
Carbomer 934
934P (0.5% w/v) 940 (0.5% w/v) 941 (0.5% w/v) Carbomer 1342 Carbomer Copolymer Carbomer Copolymer Carbomer Interpolymer |
≤0.5%
≤0.01% ≤0.5% ≤0.5% ≤0.2% ≤0.0002% ≤0.0002% ≤0.0002% |
n/a
– – – – – – – |
Free acrylic acid | ≤0.25% | ≤0.25% |
Ethylacetate
Carbomer Copolymer Carbomer Copolymer Carbomer Interpolymer Cyclohexane Carbomer Copolymer Carbomer Copolymer Carbomer Interpolymer |
≤0.5% ≤0.5% ≤0.35%
≤0.3% ≤0.3% ≤0.15% |
n/a n/a |
Assay (COOH content) | 56% – 68.0% | 56% – 68.0% |
Labelling | specified | n/a |
Key: n/a Specification is not listed
*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.
Carbomers are used as bioadhensives, controlled-release agents; emulsifying agents; emulsion stabilizers; rheology modifiers; stabilizing agents; suspending agents or occasionally, as tablet binders.
In liquid and semi-solid pharmaceutical formulations, Carbomers find the greatest utility as rheology modifiers. These types of formulation include creams, gels, lotions and ointments for use in ophthalmic, rectal, topical and vaginal preparations.
Note that carbomer grades with residual benzene content greater than 2 ppm do not meet the specifications of current pharmacopoeia monographs. Carbomers with low residuals of other solvents other than the ICH-defined ‘Class 1 – 2 solvents may he used in the EU.
Carbomers with low residuals of ethyl acetate, such as Carbopol 971P NF, are permitted to be used in oral preparations, e.g in suspensions, capsules or tablets. In tablet formulations, carbomers are used as controlled release agents and/or as binders.
A quick run-through of the properties, functions and benefits of Carbomers is below:
Key Physicochemical Properties
Applications
Advantages
Formulating Tips
Carbomers are widely used in topical liquid and semisolid pharmaceutical products. They are also used in many personal care and hygiene products as viscosity modifiers and thickeners. Currently, only grades polymerized in Ethyl acetate can be included in oral products.
Carbomers are generally deemed as effectively nontoxic and non-irritant excipients. There is currently no data that supports hypersensitivity reactions when Carbomers are used in topical products. Carbomers are also not known to be absorbed systemically following oral intake. Acute oral toxicity studies in animal models have shown that Carbomer 934P has a low oral toxicity, with no fatalities reported when doses of up to 8 g/kg were administered to canine models.
Toxicology: LD50 (rat, oral): LD50 (rat, oral): 2.5g/kg for carbomer 934P and LD50 (rat, oral): 2.5 g/kg for carbomer 940
Carbomers are stable excipients, although they exhibit hygroscopicity. They remain stable when heated at temperatures below 104 oC for up to 2 hours. Prolonged exposure to heat stress can lead to discolouration, which reduces their stability. Complete decomposition occurs when Carbomers are heated for more than 30 minutes at 260 oC. However, aqueous gels can be autoclaved without significant changes in viscosity or pH, as long as oxygen is excluded from the system.
Carbomers in dry form (powders) are not able to support mold and fungi growth. However, unpreserved aqueous dispersions are susceptible to attack. Thus, a suitable antimicrobial preservative (e.g Methylparaben at 0.18% w/v or Propylparaben at 002% w/v) should be added. The use of certain antimicrobial agents, such as Benzalkonium chloride or Sodium benzoate, especially in high concentrations (0.1% w/v) is not recommended due to the tendency to cause cloudiness and reduction in viscosity of Carbomer gels.
Carbomer gels can maintain their viscosity during storage for long periods. Exposure to light can trigger oxidation that results in the lowering of viscosity. Stability to light may be improved by the addition of 0.05 – 0.1% w/v of a water-soluble UV absorber (for instance, bensophenone-2 or bcnzophenone-4 in combination with 0.05—0.1% w/v edetic acid).
It is recommended that bulk Carbomer powders be stored in airtight, corrosion-resistant containers. The material should be protected from moisture. Glass, plastic, or resin-lined containers are ideal options for the storage of formulations that contain carbomers.
When handling bulk Carbomer powders, observe SHEQ protocols appropriate to the institutional circumstances and quantity of material being processed. Excessive dust generation should be avoided to minimise the risk of explosion. Since Carbomer dust can irritate eyes, mucous membranes, and respiratory tract, the use of appropriate PPE is necessary.
A sustainability assessment of this material has not been conducted.
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