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Polycarbophil occurs as fluffy, white to off-white, mildly acidic polymer powder with slightly acetic odor.

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Polycarbophils are synthetic, high-molecular-weight, crosslinked polymers of acrylic acid. These poly(acrylic acid) polymers are crosslinked with divinyl glycol. They are synthesized via precipitation polymerization in ethyl acetate and then dried.

Safety

Polycarbophil polymers have a long history of safe and effective use in topical gels, creams, lotions, and ointments. They have been shown to have extremely low irritancy properties and are nonsensitizing with repeated usage.
The use of these polymers is supported by extensive toxicological studies.
(guinea pig, oral): 2.0 g/kg
(mouse, IP): 0.039 g/kg
(mouse, IV): 0.070 g/kg
(mouse, oral): 4.6 g/kg
(rat, oral): >2.5 g/kg
(rabbit, skin): >3.0 g/kg
Chronic oral toxicity No significant effects in rats or dogs were observed after being fed with resin as 5% of the diet for 6? months.

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Polycarbophil polymers are stable, hygroscopic materials. They do not undergo hydrolysis or oxidation under normal conditions. Heat aging at temperatures below 104°C for up to 2 hours does not affect the efficiency of the dry polymer. However, prolonged exposure to excessive temperatures can result in discoloration, reduced stability, and in some cases plasticization of the polymer. Complete decomposition occurs with heating for 30 minutes at 260°C.
Polycarbophil polymers do not support bacteria, mold, or fungal growth in dry powder form. Microbial growth may occur in mucilages of the polymer solution. Although the gel properties are not affected by such growth, this phenomenon is usually unacceptable. The addition of appropriate preservatives prevents mold and bacterial growth in these mucilages. Mucilages and emulsions containing these polymers are stable under freeze–thaw conditions but exposure to high temperatures results in a drop in viscosity.
Polycarbophil polymers are very hygroscopic and should be packed in airtight, corrosion-resistant containers. They should be stored in a cool, dry place, and the container should be kept closed when not in use. Moisture pickup does not affect the efficiency of the resins, but resin containing high levels of moisture is more difficult to disperse and weigh accurately. Glass, plastic, or resinlined containers are recommended for products containing polycarbophil. Packaging in aluminum tubes usually requires formulations to have a pH less than 6.5, and packaging in other metallic tubes or containers necessitates a pH greater than 7.7 to prolong polycarbophil stability.

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Heat may be generated if polycarbophil comes into contact with strong basic materials such as ammonia, sodium hydroxide, potassium hydroxide, or strongly basic amines. Polycarbophil polymers are not compatible with cationic polymers, strong acids, and high levels of electrolytes, as electrolytes tend to reduce the viscosity of polycarbophil-based gels.

Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (buccal (tablet) and ophthalmic (solution) preparations; topical patches; vaginal gel). Included in nonparenteral medicines licensed in the UK.

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