"Descrizione" by Whiz35 (11828 pt) | 2023-Jul-15 09:46 |
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Polyvinylpyrrolidone vinyl acetate copolymer or PVP/VA Copolymer is a chemical compound, copolymer or copolymers that can be random or linear and are produced synthetically by the process of 'radical polymerisation' whereby a conversion of double bonds present in the monomer unit takes place, transforming them into saturated ones. This is the product of conventional radical copolymerisation of N-vinyl-2-pyrrolidone and vinyl acetate in a propan-2-ol solution with initiators.
The name describes the structure of the molecule:
The ratios of vinyl acetate to vinylpyrrolidone. can vary between 30/70 and 70/30. Polymers with 30%, 50%, 60% and 70% vinylpyrrolidone content are produced in isopropanol and ethanol. Polyvinylpyrrolidone vinylacetate copolymers with a vinylpyrrolidone content of 60 and 70 per cent are either 50 per cent aqueous solutions or solids.
The synthesis process takes place in different steps:
It appears as a white to yellowish-white powder or flakes, with an average particle size of 50-130 μm freely soluble in water, ethanol, ethylene chloride and ether, or as a transparent liquid soluble in water, ethanol, isopropanol.
What it is used for and where
Binding/coating agent
Food
In 2009, an application was submitted to the European Commission for authorisation of polyvinylpyrrolidone vinylacetate in solid food supplements: 'Food supplements in solid form, including capsules, tablets and the like, except chewing tablets. Polyvinylpyrrolidone vinylacetate copolymer improves the strength and adhesion of the coating film and increases the rate of application.
It is labelled with the number E1208 in the European food additives list as a coating agent.
Medical and Pharmaceuticals
Polyvinylpyrrolidone vinylacetate copolymer is usually associated with low concentrations of active pharmaceutical ingredients and the mechanism of drug release is controlled by the polymer (1).
Safety
According to the opinion of Commission Regulation (EU) No 264/2014 of 14 March 2014, polyvinylpyrrolidone vinyl acetate copolymer as a binding/coating agent in solid food supplements is not expected to present safety concerns (2).
The most relevant studies on this ingredient have been selected with a summary of their contents:
Typical commercial product characteristics PVP/VA Copolymer
Appearance | White powder |
Nitrogen content | 7,0-8,0 % |
pH | 3,0 – 7,0 |
Vinyl acetate | 42,0 % |
Free vinyl acetate | 5 mg/kg |
Total ash | 0,1 % |
Free N-vinylpyrrolidone | 5 mg/kg |
Hydrazine | 0,8 mg/kg |
Peroxide | 400 mg/kg |
Propan-2-ol | 150 mg/kg |
As | 3 mg/kg |
Pb | 2 mg/kg |
Mercury | 1 mg/kg |
Cadmium | 1 mg/kg |
Synonyms
References________________________________________________________________________
(1) Ritters L, Tian Y, Reichl S. Spray-Dried Paracetamol/Polyvinylpyrrolidone Amorphous Solid Dispersions: Part I-Stability of Powders and Tablets. Pharmaceutics. 2021 Nov 16;13(11):1938. doi: 10.3390/pharmaceutics13111938.
(2) L_2014076IT.01002201.xml (europa.eu)
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