Name: Poly(methyl vinyl ether/maleic anhydride)
CAS No: See Table I.
None adopted.
Butyl ester of poly(methylvinyl ether-co-maleic anhydride); calcium and sodium salts of poly(methylvinyl ether-co-maleic anhydride); Gantrez.
See Table I.
(C4H2O3C3H6O)x See Table II.
See Section 4.
Poly(methylvinyl ether/maleic anhydride) copolymers and derivatives are used in denture adhesive bases,(1) controlled-releas coatings, enteric coatings, ostomy adhesives,(2) transdermal patches,(3) toothpastes,(4) mouthwashes,(5) and transdermal gels.(6,7) Gantrez AN-119 has been used to manufacture specific bioadhesive ligand-nanoparticle conjugates(8) to aid gastrointestinal retention for oral drug delivery applications. Gantrez has also been used to develop novel polyethylene surface-modified medical devices with enhanced hydrophilicity and wettability.(9)
In the solid state, poly(methylvinyl ether/maleic anhydride) copolymers are a white to off-white free flowing, odorless, hygroscopic powders. In solution, poly(methylvinyl ether/maleic anhydride) is a slightly hazy, odorless, viscous liquid.
See Table III.
Poly(methylvinyl ether/maleic anhydride) and related free acids are hygroscopic powders, and therefore excessive exposure to moisture should be avoided. Aqueous solutions exhibit decreases in viscosity upon exposure to UV light. Poly(methylvinyl ether/maleic anhydride) should be stored in a cool, dry place out of direct sunlight
Poly(methylvinyl ether/maleic anhydride) and copolymers are incompatible with strong oxidizing agents and reducing agents, concentrated nitric acid, sulfuric acid, nitrofoam, oleum, potassium t-butoxide, aluminum, aluminum triisopropoxide, and crotonaldehyde. In addition, the anhydride will hydrolyze in water to form a water-soluble free acid that can subsequently be ionized to form salts in the presence of cations (Naþ, Zn2þ, Ca2þ, and Al3þ). Excessive addition of bivalent and trivalent metal ions to aqueous solution will result in precipitation, particularly in solutions containing high polymer concentrations.
Poly(methylvinyl ether/maleic anhydride) and copolymers are manufactured from methylvinyl ether and maleic anhydride. The S, ES, and MS grades of Gantrez are manufactured by dispersing AN copolymers in a number of different solvents or salt solutions.(1
Poly(methylvinyl ether/maleic anhydride) and copolymers are widely used in a diverse range of topical and oral pharmaceutical formulations.(11) These copolymers are generally regarded as nontoxic and nonirritant. Moreover, the dry powders and aqueous solutions are nonirritating with the exception of ES, MS, and A grades, which are irritating to the eye and may cause tissue damage. LD50 (rat, oral): 8 g/kg (Gantrez AN-130 Powder) (10) LD50 (rat, oral): 40 ml/kg (Gantrez AN-139 20% w/w aqueous solution) LD50 (rat, oral): >25.6 g/kg (Gantrez ES-225) LD50 (rat, oral): 25.6 g/kg (Gantrez ES-425 40% w/v corn oil solution) LD50 (rat, oral): >5.0 g/kg (Gantrez MS-955 20% aqueous solution)
Observe normal precautions appropriate to the circumstances and quantity of material handled. Excessive dust generation should be avoided when using powders, and an appropriate ventilation area and dust mask are recommended. Hand and eye protection is also recommended. The A, ES, and MS copolymers are extremely irritating to the eyes and a NIOSH-approved respirator and suitable eye protection are recommended when using Gantrez ES-435, Gantrez ES-225, and Gantrez A-425
GRAS listed. Included in nonparenteral medicines licensed in the UK.