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Polyvinyl Acetate

Phthalate

Nonproprietary Names :
USP-NF: Polyvinyl Acetate Phthalate

Synonyms :
Phthalavin; PVAP; Opaseal; Sureteric.

Empirical Formula and Molecular Weight :


The USP32NF27 describes polyvinyl acetate phthalate as a reaction product of
phthalic anhydride and a partially hydrolyzed polyvinyl acetate. It contains not less
than 55.0% and not more than 62.0% of phthalyl (o-carboxybenzoyl, C8H5O3)
groups, calculated on an anhydrous acid-free basis. It has been reported that the free
phthalic acid content is dependent on the source of the material.

Functional Category :
Coating agent.

Applications in Pharmaceutical Formulation or


Technology 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.
Plasticizers are often included in polyvinyl acetate phthalate coating
formulations to enable a continuous, homogeneous, noncracking film to
be produced.
Polyvinyl acetate phthalate has been shown to be compatible with
several plasticizers such as glyceryl triacetate, triethyl citrate, acetyl
triethylcitrate, diethyl
phthalate and polyethylene glycol 400.
For enteric coating applications, polyvinyl acetate phthalate is dissolved
in a solvent system together with other additives such as diethyl
phthalate and stearic acid. Methanol may be used as the solvent if a

colorless film is required; for a colored film, methanol or ethanol/water


may be used depending on the amount of pigment tobe incorporated.
A weight increase of up to 8% is necessary for nonpigmented systems,
whereas for pigmented systems a weight increase of 6% is usually
required. A formulated, aqueous-based coating solution ( Sureteric,
Colorcon) is available commercially for the enteric coating of tablets,
hard and soft gelatin capsules and granules. More recently, hot-melt
extrusion of coating polymers, such as polyvinyl acetate phthalate, has
been described for the enteric coating of capsules.
Polyvinyl acetate phthalate has superseded materials such as shellac in
producing the initial layers of coating (the sealing coat) in the sugar
coating process for tablets.
The sealing coating should be kept as thin as possible while providing an
adequate barrier to moisture, a balance that is often difficult to achieve
in practice.
A solvent system containing a high proportion of industrial methylated
spirits and other additives can be used. Two coats are usually sufficient
to seal most tablets, although up to five may be necessary for tablets
containing alkaline ingredients. If an enteric coating is also required,
between six and 12 coats may be necessary
The properties of polyvinyl acetate phthalate enteric coating have been
compared with those of other enteric polymers such as cellulose acetate
phthalate, and Eudragit L 30D.
The factors that affect the release kinetics from polyvinyl acetate
phthalate
enteric-coated tablets have also been described.
A method for enteric coating hypromellose capsules which avoids the
sealing step prior to coating has been developed.
The properties of several enteric coating polymers, including polyvinyl
acetate phthalate, were assessed.
Use
Tablet enteric film coating
910
Tablet sealant (sugar-coating) 2829

Concentration (%)

Description :

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.

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.

Stability and Storage Conditions :


Polyvinyl acetate phthalate should be stored in airtight containers

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.

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