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PVP/VA 64 is a 6:4 linear random copolymer of N-vinylpyrrolidone and vinyl acetate.
The vinyl acetate component of PVP/VA 64 reduces the hydrophilicity and glass transition temperature (Tg) compared to povidone homopolymers of similar molecular weight.
As a result,PVP/VA 64 is the ultimate tablet binder that extends its excellent adhesive property in wet granulation, as well as in dry granulation and direct compression.
CAS: 25086-89-9
MF: C10H15NO3
MW: 197.23
Description
Due to its spherical, hollow particle morphology and high plasticity,PVP/VA 64 performs exceptionally well as a binder for direct compression.
In addition, a lower Tg makes PVP/VA 64 an ideal polymer matrix for solid dispersions/solutions via hot melt extrusion, which enhances the dissolution of poorly soluble drug actives.
PVP/VA 64, which is also known as Vinylpyrrolidone-vinyl acetate or Copolyvidone, is acetic acid ethenyl ester polymer with 1-etheny1-2 pyrrolidinone.
PVP/VA 64 is a synthetic random copolymer of 1-vinyl-2-pyrrolidone and vinyl acetate in a ratio (by weight) of 6:3.
In the PVP/VA 64 is defined as a copolymer of 1-ethenylpyrrolidin-2-one and ethenyl acetate in the mass proportion of 3:2.
PVP/VA 64 is an analogue of Povidone, and corresponds to the general chemical formula shown below:
(C6H9NO)n (C4H6O2)m (111.1)n + (86.1)m (the ratio of n to m is approximately n = 1.2m).
PVP/VA 64’s (average) molecular weight is usually expressed as a K-value.
The PVP/VA 64 is nominally 28, with a range of 25.2-30.8 while the K-value for Plasdone S 630 (Ashland) is specified to be between 25.4 and 34.2.
PVP/VA 64 is calculated from the kinematic viscosity of a 1% aqueous solution.
From this information, the molecular weight can be calculated using the formula below:
M = 22.22 (K + 0.075K2)1.65.
PVP/VA 64, together with the other polyvinylpyrrolidone polymers (e.g Povidone and Crospovidone) are some of the many materials that were first commercialised by BASF in the early 1930s as part of the company’s acetylene chemistry programme (started and led by the chemist, Walter Reppe).
Over the course of several decades, Pyrrolidones have been adapted and applied across multiple fields, including pharmaceuticals, cosmetics, and food owing to versatility, solubility and consistency in their many performance attributes.
The method used to synthesise PVP/VA 64 is very much similar to that used by Povidone, that is, the Reppe process is used to produce Polyvinylpyrrolidone, which is then copolymerised with Vinyl acetate.
However, as the Vinyl acetate is insoluble in water the reaction is carried out in an organic solvent rather than water.
The presence of Vinyl acetate in the molecule renders PVP/VA 64 more hydrophobic compared with Povidone and also makes its films less brittle.
Indeed, PVP/VA 64 was the desire to improve upon Povidone’s technological attributes that motivated the development of povidone derivatives.
Compared with Povidone, PVP/VA 64 is more versatile as an excipient.
PVP/VA 64 also exhibits greater plasticity and gives granules and powder mixtures flexibility to deform thereby reducing tendencies to undergo capping and lamination during tabletting. PVP/VA 64 is supplied as a white to white-yellow amorphous, finely divided powder.
Moderately toxic by ingestion.
Combustible, especially in powdered form.
Incompatiblewith strong oxidising agents, strong reducing agents.
When heated to decomposition PVP/VA 64 emits toxic vapors of NOx.
PVP/VA 64 is used widely in pharmaceutical formulations and is generally regarded as nontoxic. However, PVP/VA 64 is moderately toxic by ingestion, producing gastric disturbances.
PVP/VA 64 has no irritating or sensitizing effects on the skin.
A study was conducted to look at the carcinogenicity and chronic toxicity of copovidone PVP/VA 64 in Wistar rats and Beagle dogs.
The results of these studies demonstrated the absence of any significant toxicological findings of high dietary levels of copodivone in rats and dogs, resulting in noobserved- adverse-effect levels of 2800 mg/kg body-weight/day in rats and 2500 mg/kg body-weight/day in dogs, the highest doses tested.
PVP/VA 64, is a film forming agent that offers a strong, stiff hold in hair care.
PVP/VA 64 offers curl retention in high humidity.
PVP/VA 64 forms transparent, flexible, and breathable films.
PVP/VA 64 has been used in pharmaceuticals for several decades as an excipient.
PVP/VA 64 is generally regarded as nontoxic raw material.
The US FDA now considers PVP/VA 64 GRAS (Self Affirmed) and has approved its use in food and nutritional supplements.
PVP/VA 64 has no irritating or sensitizing effects on the skin.
The safety of PVP/VA 64 as an excipient in solid oral dosage forms is evidenced by several non-clinical studies.
These studies have demonstrated the absence of any significant toxicological effects (in animal models), resulting in no-observed-adverse-effect levels of 2800 mg/kg body-weight/day in rats and 2500mg/kg body-weight/day in dogs.
PVP/VA 64 Chemical Properties
Density: 1.27 g/mL at 25 °C(lit.)
Refractive index: 1.4300 to 1.4380
Fp: 72 °F
Solubility: Greater than 10% solubility in 1,4-butanediol, glycerol, butanol, chloroform, dichloromethane, ethanol (95%), glycerol, methanol, polyethylene glycol 400, propan-2-ol, propanol, propylene glycol, and water.
Less than 1% solubility in cyclohexane, diethyl ether, liquid paraffin, and pentane.
Form: powder
Color: White
Stability: Stable. Combustible, especially in powdered form.
Incompatible with strong oxidising agents, strong reducing agents.
EPA Substance Registry System: PVP/VA 64 (25086-89-9)
PVP/VA 64 is a white to yellowish-white amorphous powder.
PVP/VA 64 is typically spray-dried with a relatively fine particle size.
PVP/VA 64 has a slight odor and a faint taste.
Uses
PVP/VA 64 is a water-soluble polymer used to improve the uptake and drug loading of various pharmaceutical agents, including contraceptive patches.
PVP/VA 64 is used as a tablet binder, a film-former, and as part of the matrix material used in controlled-release formulations.
In tableting, PVP/VA 64 can be used as a binder for direct compression and as a binder in wet granulation.
PVP/VA 64 is often added to coating solutions as a film-forming agent.
PVP/VA 64 provides good adhesion, elasticity, and hardness, and can be used as a moisture barrier.
Applications in Pharmaceutical Formulations or Technology
PVP/VA 64 was developed as an improvement over Povidone (binder).
PVP/VA 64's favourable technical properties, namely better flowability, lower hygroscopicity, spherical particle shape, plasticity, lower glass-transition temperature, and hydrophobic–hydrophilic balance, rendered Copovidone highly advantageous in direct compression and roller-compaction tabletting operations.
While PVP/VA 64 is still used as a dry binder (for direct compression and roller compression), PVP/VA 64's main utility is as a matrix former for the development of solid dispersions, film former (especially in the formulation of moisture-barrier coatings), and as a matrice former for sustained-release solid dosage forms.
1). Binder in Tablets
PVP/VA 64 performs superbly as a dry binder for direct compression applications.
PVP/VA 64 is particularly preferred for formulations susceptible to capping due to its plasticity.
Finer grades have demonstrated superior binding performance compared with either PVP/VA 64 and Cellulose-based polymers.
Formulations developed with PVP/VA 64 show a direct relationship between tablet hardness, friability, porosity and disintegration with the applied compaction force.
2). Binder in Wet Granulation
The high solubility of PVP/VA 64 in water and standard granulation liquids makes it as an ideal binder in wet granulation operations.
PVP/VA 64 may be added either as a solution or in the form of a dry powder followed by the addition of the granulating solvent or a combination of both.
PVP/VA 64, owing to its low hygroscopicity, allows greater predictable granulation endpoints and its granules have a much less propensity to stick to tooling, even when conducted under less favourable conditions.
3). Roller Compression
PVP/VA 64 has been shown to be particularly well-suited for use in roller compaction.
PVP/VA 64 is an excipient of choice when particle size distribution and particle shape considerations are critical during roller compression process design.
Owing to its spherical shape and fine size PVP/VA 64 gives better surface coverage and develops multiple bridges that lead to hard tablets with a reduced friability.
4). Film-Coating Film Former
PVP/VA 64 is a film former and it soluble membranes whose solubility is independent of pH. PVP/VA 64 films are also less hygroscopic, but more flexible compared with those formed by Povidone.
For best results, PVP/VA 64’s used in combination with other film-forming polymers that are less hygroscopic.
Due to PVP/VA 64's flexibility, a plasticizer is not required.
5). Polymer for Amorphous Solid Dispersions
PVP/VA 64 is a suitable polymer for developing amorphous solid dispersions that are both kinetically and thermodynamically stable.
Both spray-drying and hot melt extrusion approaches can be reliably used.
6). Other Uses
Inhibition of crystallisation of APIs in liquid soft-gel formulations
Sugar coating applications (to improve adhesion)
Subcoating of tablets (film coating)
APPLICATIONS: Hairsprays, mousses, coloring products, mousses, gels, styling lotions and conditioners.
INCI: VP/VA Copolymer
Solubility: Water (Heats accelerates hydration)
Use rate: 0.5 – 6.0% (Recommended use rate 3.0 – 5.0% for gels, creams, mousses and styling lotions)
Temperature tolerance: Avoid temperatures above 80°C
pH Stability: 4.0 – 7.0
Appearance: white to slightly yellowish, fine to coarse grained powder.
Assay: 60% VP (vinylpyrrolidone) / 40% VA (vinyl acetate) is available in powder form.
Storage: Store in a cool, dark, and dry place
A natural, biodegradable physical exfoliant, fine enough for gentle, facial abrassion
Stability and Storage Conditions
PVP/VA 64 is stable and should be stored in a well-closed container in a cool, dry place.
The standard shelf life is given as 24 months.
However, when PVP/VA 64 is exposed to high moisture levels, its stability may be reduced. Correct storage of the raw material is therefore highly advised.
In order to minimise any adverse effects, observance of SHEQ precautions consistent with operational circumstances and the quantity of material handled is advised.
The use of eye protection, gloves, and a dust mask is also advised.
Synonyms
25086-89-9
Polectron 845
Luviskol VA 28I
Luviskol VA 37E
Luviskol VA 64
Kolima 10
Kolima 35
ethenyl acetate;1-ethenylpyrrolidin-2-one
Gantron S 860
PVP-VA
Ganex E 535
GAF-S 630
Luviskol VA 281
Luviskol VA 28 I
Luviskol VA 37 E
I 535
I 635
I 735
S 630
MFCD00134018
Luviskol VA-64
SCHEMBL29127
Copovidone (Technical Grade)
vinylpyrrolidone/vinyl acetate
Vinyl Pyrrolidone/Vinyl Acetate
N-vinylpyrrolidone/vinyl acetate
1-vinylpyrrolidone vinyl acetate
BCP31918
NSC114023
NSC114024
NSC114025
NSC114026
AKOS015898247
NSC-114023
NSC-114024
NSC-114025
NSC-114026
1-ethenylpyrrolidin-2-one; ethenyl acetate
ethenyl ethanoate; 1-ethenylpyrrolidin-2-one
FT-0659810
A817635
acetic acid ethenyl ester; 1-ethenyl-2-pyrrolidinone
733045-73-3
