Poly methyl vinyl ether maleic anhydride

Category

Bioadhesive Material; Color Dispersant; Emulsion Stabilizer; Film-forming Agents; Viscosity-increasing Agents

Molecular Formula

(C4H2O3·C3H6O)x

Grade

Pharmceutical Excipients

Description

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.

UNII

NA

Chemical Name

/

CAS Number

/

Synonyms

Butyl ester of poly(methylvinyl ether-co-maleic anhydride); calcium and sodium salts of poly(methylvinyl ether-co-maleic anhydride); Gantrez

Stability and Storage Conditions

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 sunligh.

Source and Preparation

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.

Applications

Poly(methylvinyl ether/maleic anhydride) copolymers and derivatives are used in denture adhesive bases, controlled-releas coatings, enteric coatings, ostomy adhesives, transdermal patches, toothpastes, mouthwashes, and transdermal gels. Gantrez AN-119 has been used to manufacture specific bioadhesive ligand-nanoparticle conjugates 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.

Safety

Poly(methylvinyl ether/maleic anhydride) and copolymers are widely used in a diverse range of topical and oral pharmaceutical formulations. 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) 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)

Incompatibilities

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 (Na+, Zn2+, Ca2+, and Al3+). Excessive addition of bivalent and trivalent metal ions to aqueous solution will result in precipitation, particularly in solutions containing high polymer concentrations.