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    Polyvinyl Acetate Phthalate (PVAP)

    Nonproprietary Names:

    Polyvinyl Acetate Phthalate

    Synonyms:

    Polyvinyl Acetate Phthalate, PVAP

    Chemical Name & CAS No.

    Polyvinyl Acetate Phthalate; [34481-48-6]

    Functional Category:

    Coating Agent.

    Product Description:

    Polyvinyl acetate phthalate is a reaction product of phthalic anhydride, sodium acetate, and a partially hydrolyzed polyvinyl alcohol. The polyvinyl alcohol is a low molecular weight grade, and 87–89 mole percent is hydrolyzed. Therefore, the polyvinyl acetate phthalate polymer is a partial esterification of a partially hydrolyzed polyvinyl acetate. Polyvinyl acetate phthalate is a free-flowing white to off-white powder and may have a slight odor of acetic acid. The material is essentially amorphous.

    Polyvinyl acetate phthalate is a viscosity-modifying agent that is used in pharmaceutical formulations to produce enteric coatings for products and for the core sealing of tablets prior to a sugar-coating process. Polyvinyl acetate phthalate does not exhibit tackiness during coating and produces strong robust films.

    Solubility of Polyvinyl Acetate Phthalate

    Soluble in ethanol and methanol; sparingly soluble in acetone and propan-2-ol; practically insoluble in chloroform, dichloromethane, and water. In buffer solutions, polyvinyl acetate phthalate (200 mg/L) is insoluble below pH 5 and becomes soluble at pH values above 5. Polyvinyl acetate phthalate shows a sharp solubility response with pH; this occurs at pH 4.5–5.0, which is lower than for most other polymers used for enteric coatings. Solubility is also influenced by ionic strength.

    Stability and Handling:

    Polyvinyl acetate phthalate should be stored in airtight containers. It is relatively stable to temperature and humidity, and does not age, giving predictable release profiles even after prolonged storage. At high temperature and humidity, polyvinyl acetate phthalate undergoes less hydrolysis. Polyvinyl acetate phthalate is used in oral pharmaceutical formulations and is generally regarded as an essentially nonirritant and nontoxic material when used as an excipient. Observe normal precautions appropriate to the circumstances and quantity of material handled. Gloves and eye protection are recommended.

    Specification of Polyvinyl Acetate Phthalate:

    PropertiesSpecifications
    USP / NF
    IdentificationA. The Sample solution in the Assay exhibits a maximum at 277 ± 3 nm.
    B. The solution shows a vivid green fluorescence.
    C. A film is deposited as the methanol evaporates.
    Viscosity @ 25°C7cps – 11cps
    Water ContentNMT 5.0%
    Residue on IgnitionNMT 1.0%
    Free Phthalic AcidNMT 0.6%
    Free Acid Other than PhthalicNMT 0.6%
    Phthalyl Content55.0% – 62.0%