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Phthalate
Nonproprietary Names :
USP-NF: Polyvinyl Acetate Phthalate
Synonyms :
Phthalavin; PVAP; Opaseal; Sureteric.
Functional Category :
Coating agent.
Concentration (%)
Description :
Solubility :
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 pththalate
shows a sharp solubility response with pH; this occurs at pH 4.55.0,
which is lower than for most other polymers used for enteric
coatings. Solubility is also influenced by ionic strength.
Solvent
Solubility at 258C
Acetone/ethanol (1 : 1 w/w)
1 in 3
Acetone/methanol (1 : 1 w/w)
1 in 4
Ethanol (95%)
1 in 4
Methanol
1 in2
Methanol/dichloromethane (1 : 11 in 3
w/w)
Solubility of polyvinyl acetate phthalate.
Incompatibilities :
Polyvinyl acetate phthalate reacts with povidone to form an
insoluble complex that precipitates out of solution; benzocaine is
also incompatible with polyvinyl acetate phthalate.Erythromycin
disperses in polyvinyl acetate phthalate and has been shown to be
physically stable while omeprazole exists in the amorphous form in
polyvinyl acetate phthalate coatings with no evidence of
interaction.
Safety :
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.