polyvinylacetate phthalate polymer Chemische Eigenschaften,Einsatz,Produktion Methoden
Chemische Eigenschaften
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.
Vorbereitung Methode
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.
Sicherheit(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.
Lager
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 than other commonly used enteric coating
polymers. In aqueous colloidal dispersions of polyvinyl acetate
phthalate, the formation of free phthalic acid through hydrolysis
was found to adversely affect physical stability.
Following storage at room temperature for 9 months, capsules
coated with a commercial polyvinyl acetate phthalate formulation
(Coateric) were found to retain gastroresistant properties and
showed no apparent physical change; however, a delayed drug
dissolution profile was observed after storage. Storage at 37°C, or
37°C and 80% relative humidity, for 3 months resulted in capsules
having an unsatisfactory appearance.
Inkompatibilitäten
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.
Regulatory Status
Included in the FDA Inactive Ingredients Database (sustainedaction
oral tablet). Included in nonparenteral medicines (enteric
coated tablets; in printing ink formulations used for oral tablets and
capsules) licensed in Europe. Included in the Canadian List of
Acceptable Non-medicinal Ingredients.
polyvinylacetate phthalate polymer Upstream-Materialien And Downstream Produkte
Upstream-Materialien
Downstream Produkte
