PVP VA 64 is a white or slightly yellowish, free-flowing powder with a faint characteristic odor and practically no taste.
PVP VA 64 readily dissolves in all hydrophilic solvents.
Solutions of more than 10 % concentration can be prepared in water, ethanol, isopropanol, methylene chloride, glycerol and propylene glycol.
CAS Number: 25086-89-9
INCI name: VP/VA Copolymer
PVP VA 64 is a VP/VA copolymer.
PVP VA 64 acts as as a film-forming agent and fixative in hair care.
PVP VA 64 is a copolymer of 1-vinyl-2-pyrrolidone & vinyl acetate in ratio of 60:40 in the form of powder.
PVP VA 64 is suitable for hair sprays and hair set lotion.
PVP VA 64 is less soluble in ether, cyclic, aliphatic and alicyclic hydrocarbons.
Benefits of PVP VA 64:
PVP VA 64 provides erodible instant release matrix
PVP VA 64 is a solubilizer, dispersant, crystallization inhibitor and matrix former
For direct compression, roller compaction and wet granulation, suitable for markets with higher humidity exposure
PVP VA 64 has excellent stability throughout the extrusion process
A coarse powder provides a dust free handling, good flowability and faster extruder feeding
Recently obtained GRAS/SA status (Generally Recognized As Safe/Self-Affirmed) by the U.S. Food & Drug Administration (FDA) for use in food and nutritional supplements e.g. vitamin and mineral tablets
PVP VA 64 is a copolymer of vinylpyrrolidone with vinyl acetate in an an easy-to-use aqueous solution.
PVP VA 64 preserved with 0.05% max. dodecyl trimethyl ammonium chloride.
PVP VA 64 is an excellent film-former and hair styling agent.
Specifications of PVP VA 64:
Appearance : White – Cream Powder
K value(1% in ethanol): 26.0-34.0
Vinyl pyrrolidone: 60
Vinyl acetate: 40
pH (10% solution) 4-7
Solids content: 95%
Properties of PVP VA 64:
PVP VA 64 is an easy-to-use aqueous solution that is compatible with carbomers, and is particularly suitable for alcohol-free formulations, forming a clear solution in water.
Functions of PVP VA 64:
-Binding.
-Film forming.
-Hair fixing.
-Viscosity controlling.
Applications of PVP VA 64:
PVP VA 64 is used in hair care like aerosol sprays, non-aerosol products, liquid hair setting products, gels and mousses.
Recommended Dosage of PVP VA 64:
The following concentrations are recommended (solids):
˗ Aerosol hair spray 2 - 6%
˗ Pump spray 3 - 7%
˗ Setting lotions 1 - 5%
˗ Setting mousse 1 - 5%
˗ Gels 1 - 5%
˗ Hair waxes 1 - 5%
PVP VA 64 is a copolymer of 1-vinyl-2-pyrrolidone & vinyl acetate in ratio of 60:40 in the form of powder.
KEYWORDS:
25086-89-9, VP/VA Copolymer, PVP VA, acetic acid ethenyl ester polymer with 1-ethenyl-2-pyrrolidinone, ethenyl acetate;1-ethenylpyrrolidin-2-one, poly(1-vinyl pyrrolidone-co-vinyl acetate), PVP VA W635, PVP VA E735, PVP VA 60/40, PVP VA 64W
Storage of PVP VA 64:
Store PVP VA 64 at a cool, dry and well ventilated place.
PVP VA 64 Description:
Various percentages of vinylpyrrolidone to vinyl acetate can be offered in powder, alcohol solution, and aqueous products.
The product of the aqueous solution can vary from clear to cloudy.
The clarity of the solution depends on the proportion of vinylpyrrolidone to vinylacetate.
The solution is slightly acidic, but not electrolytic.
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 (T g ) 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.
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 T g 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 is a vinylpyrrolidone-vinyl acetate copolymer.
PVP VA 64 is used in the pharmaceutical industry as dry binder in tablets, as matrix formers for amorphous solid dispersions, as retarding and as film-forming agents.
Benefits
• Suitability for use in direct compression, dry granulation, wet granulation, hot melt extrusion, and film coating.
• Good flowability
• Large surface area due to hollow particle morphology – enhances particle bonding and good compressibility
• Ideal glass transition temperature (Tg) for hot melt extrusion
Introduction to PVP VA 64:
PVP VA 64 is a vinylpyrrolidone-vinyl acetate copolymer which is soluble both in water and in alcohols.
PVP VA 64 is well-known by their monographic name "Copovidone" or "Copolyvidone".
In the pharmaceutical industry they are widely used as dry and wet binder in tablets, as film forming agent or in retard formulations.
A major application of PVP VA 64 is as matrix in amorphous solid dispersions.
Technical properties and description of PVP VA 64:
PVP VA 64 is a spray dried polymer powder of a copolymer derived from the monomers N-vinylpyrrolidone (NVP) and vinyl acetate (VAc) with a weight ratio of approx. 6:4.
The powders are white or slightly yellowish, have a faint characteristic odor and practically no taste.
CAS-number:
25086-89-9
Infrared spectrum of PVP VA 64:
The infrared spectrum shown in spectrum was obtained with a tablet of PVP VA 64 in potassium bromide.
Arrows indicate where the spectrum differs from that of povidone.
Molecular weight of PVP VA 64:
The average molecular weight is usually expressed as a K value.
The exact weightaverage molecular weight, Mw of the product is best determined by measuring the light scatter of a solution.
Values in the range of 45,000 – 70,000 have been determined for PVP VA 64.
Solubility of PVP VA 64:
PVP VA 64 is readily dissolve in all hydrophilic solvents.
Solutions of more than 10% concentration can be prepared in: water, ethanol, isopropanol, methylene chloride, glycerol and propylene glycol
PVP VA 64 is less soluble in: ether, cyclic, aliphatic and alicyclic hydrocarbons
Viscosity of PVP VA 64:
The values shown were determined at 25 °C in a capillary viscometer.
They represent typical values
Bulk density of PVP VA 64:
The bulk density of PVP VA 64 usually lies in the range of 0.08 – 0.15 g/ml.
Particle size distribution of PVP VA 64:
Typical values for the particle size of PVP VA 64 is as follows:
>250 µm [%] / max. 7% / max. 2%
<50 µm [%] / max. 35% / min. 35%
Example application General of PVP VA 64:
Copovidone has been used for decades in the pharmaceutical industry.
Up to about 1975 it was marketed under the name of PVP VA 64, which today is used only for the technical/cosmetic grade of this copolymer.
This is why older publications often refer to the use of PVP VA 64 in pharmaceuticals.
Binder for tablets and granules
PVP VA 64 is excellent binders for tablets and granules.
Between 2% and 8%, as a proportion of the final weight of the preparation, is usually used.
An important property of PVP VA 64 in this application is the plasticity, which distinguishes the products from povidone.
This property often gives granules and mixtures that are less susceptible to capping during tabletting, and tablets that are less brittle.
Dry Binder for direct compression of PVP VA 64:
PVP VA 64 have been found to be excellent dry binders for direct compression.
Especially the PVP VA 64 gives much better results than any of the Povidone grades or other dry-binders of the group of cellulose derivatives.
The hardness, friability, porosity and disintegration time of lactose and starch placebo tablets produced with PVP VA 64 is directly related to the compression force used.
PVP VA 64 can be added to materials such as sorbitol, mannitol, starch, or direct compression aids, e.g. micro crystalline cellulose, whose own binding strength is inadequate, to give tablets with very good properties.
The literature contains a large number of vitamin formulations with PVP VA 64.
Ascorbic acid chewable tablets 100 mg:
Ascorbic acid powder 42.4%
Sucrose ground 13.0%
Sucrose crystalline 8.0%
Microcrystalline cellulose 28.3%
Kollidon® VA 64 2.4%
Polyethylene glycol 6000 powder 2.0%
Orange aroma + strawberry aroma (2 + 1) 1.2%
Cyclamate sodium 2.4%
Saccharin sodium 0.1%
Aerosil 200 0.2%
Tablet Properties:
Weight 250 mg
Hardness 157 N
Friability <0.1%
Acetyl salycilic acid tablets 500 mg formulated with PVP VA 64:
Acetylsalicylic acid 500.0 mg
Avicel PH 102 200.0 mg
Kollidon® VA 64 Fine 60.0 mg
Kollidon® CL 25.0 mg
Magnesium stearate 3.0 mg
Total 788.0 mg
The individual components were sieved through a 0.8 mm sieve.
After a blending time of 10 minutes in a Turbula Blender the powder blend is compressed with compression forces of 6, 10, and 18 kN respectively.
Wet granulation of PVP VA 64:
PVP VA 64 can also be used as a binder in wet granulation for the production of tablets and granules, since it is readily soluble in all the usual solvents.
PVP VA 64 can then be added either as a solution during granulation, or dry to the other ingredients, in which case the solvent is added alone during granulation.
Trials so far conducted with both methods, using equal quantities of liquid, produced tablets of much the same hardness.
A combination of the two methods, i.e. mixing some of the PVP VA 64 with the active ingredient, and dissolving the rest in the solvent, sometimes gives the best results.
This is particularly recommended if the active ingredient does not readily absorb the solvent.
Since it is less hygroscopic than povidone, PVP VA 64 gives granules that have less tendency to stick to the punches of the tabletting machine, when operating under humid conditions.
Roller compaction of PVP VA 64:
PVP VA 64 was specifically suitable for the application in roller-compaction and is the material of choice in terms of particle size distribution and particle shape for this application.
Due to the particle size PVP VA 64 is able to cover a bit surface area and to form numerous bridges in the tablet structure that lead to hard tablets with a reduced friability.
Film-coating of PVP VA 64:
PVP VA 64 forms films that are soluble at all pH values.
They are less hygroscopic and more elastic than those formed by povidone.
Nevertheless, PVP VA 64 usually still absorbs too much water, so that it can seldom be used as the sole film-forming agent in a formulation.
It is therefore recommended to combine it with less hygroscopic substances such as cellulose derivatives, shellac or polyethylene glycol.
Plasticizers are normally not required.
The formulations in Tables 4 and 5 are typical formulations for tablet coatings.
They were tested on 9 mm diameter, 3.4 mm thick, 200 mg placebo tablet cores in the laboratory.
PVP VA 64 significantly improves their brittleness and solubility when it is combined with cellulose derivatives.
When it is used in film coatings based on shellac, the properties of the film are more consistent.
Subcoating of PVP VA 64:
If it is intended to coat tablet cores with aqueous solutions or suspensions, it is recommended to provide them with a barrier if they contain a watersensitive active ingredient or a highly effective disintegrant that is activated by water.
This also applies if the cores are too soft or if their adhesive properties are inadequate for aqueous coatings.
The cores are warmed to about 35 °C and sprayed with a 10% solution of PVP VA 64 dissolved in an organic solvent, e.g. isopropanol, ethanol, ethyl acetate or acetone.
As soon as a barrier film of adequate thickness has been built up, the aqueous coating can be applied.
It has been found that 0.4 mg PVP VA 64 is adequate.
Sugar-coating of PVP VA 64:
PVP VA 64 is used in sugar-coating to improve the adhesion of the coating to the surface of the tablet core and to increase the capacity of the coating solution for pigments and improve their dispersibility.
However, PVP VA 64 helps not only in the application of sugar coatings but also in the automation of the sugar-coating process.
Amorphous Solid Dispersions of PVP VA 64:
Poorly water-soluble drugs are a constant and growing challenge within the pharmaceutical industry.
One proven and viable technology to overcome this challenge is the production of amorphous solid dispersions or ASDs.
ASDs are prepared by dissolving the poorly soluble drug within a polymeric matrix, which then releases the drug upon contact with aqueous media, and results in an overall increase of drug solubility and dissolution rate.
ASDs may be prepared using well proven methods such as hot melt extrusion, or for temperature sensitive drugs, spray drying.
For both technologies, PVP VA 64 has proven its suitability to generate thermodynamically and kinetically stable forms of solid API dispersions in a polymer matrix.
Amorphous Solid Dispersions by melt extrusion
The formulation of stable amorphous solid dispersion by melt extrusion based on PVP VA 64 has been established for more than two decades.
This polymer has proved its suitability for this application because of its low glass transition temperature (101 °C), high temperature resistance (up to 220 °C) and optimum thermorheological properties.
A number of product parameters have been optimized to minimize degradation of the API during melt extrusion and to ease powder handling.
First, the LOD/water content of PVP VA 64 was adjusted to a level below the compendial upper limit to reduce the concentration of API degradation products during processing.
Secondly, the particle size and morphology were optimized to reduce dust formation during powder dispensing, mixing operations and extruder feeding.
The resulting intermediate extrusion products can be processed downstream by either filling them directly into hard gelatin capsules or by subsequently milling the extrudates and processing tablet cores or coated tablets.
Handling & Safety of PVP VA 64:
Please refer to the individual material safety data sheet (MSDS) for instructions on safe and proper handling and disposal.
The purpose of this study was to explore poly(vinylpyrrolidone-co-vinyl acetate) (PVP VA64) as a novel release-modifier to tailor the drug release from ethylcellulose (EC)-based mini-matrices prepared via hot melt extrusion (HME).
Quetiapine fumarate (QF) was selected as model drug.
PVP VA 64 mini-matrices were extruded with 30% drug loading.
The physical state of QF in extruded mini-matrices was characterized using differential scanning calorimetry, X-ray powder diffraction, and confocal Raman microscopy.
The release-controlled ability of PVP VA 64 was investigated and compared with that of xanthan gum, crospovidone, and low-substituted hydroxypropylcellulose.
The influences of PVP VA 64 content and processing temperature on QF release behavior and mechanism were also studied.
The results indicated QF dispersed as the crystalline state in all mini-matrices.
The release of QF from EC was very slow as only 4% QF was released in 24 h.
PVP VA 64 exhibited the best ability to enhance the drug release as compared with other three release-modifiers.
The drug release increased to 50-100% in 24 h with the addition of 20-40% PVP VA 64.
Increasing processing temperature slightly slowed down the drug release by decreasing free volume and pore size.
The release kinetics showed good fit with the Ritger-Peppas model.
The values of release exponent (n) increased as PVP VA 64 is added (0.14 for pure EC, 0.41 for 20% PVP VA 64, and 0.61 for 40% PVP VA 64), revealing that the addition of PVP VA 64 enhanced the erosion mechanism.
This work presented a new polymer blend system of EC with PVP VA 64 for sustained-release prepared via HME.
Synonyms:
acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone
ethenyl acetate;1-ethenylpyrrolidin-2-one
poly(1-vinyl pyrrolidone-co-vinyl acetate)