Kollidon-Va-64 Technical Information

Technical Information
Kollidon® VA 64
Kollidon VA 64 Fine
®
Copovidone Ph. Eur., USP, Copolyvidone JPE.
Kollidon® VA 64 and Kollidon® VA 64 Fine are vinylpyrrolidone-vinyl acetate copolymers. They are
used in the pharmaceutical industry as dry binder in tablets, as matrix formers for amorphous solid
dispersions, as retarding and as film-forming agents.
June 2021 | Supersedes issue dated March 2019 | Last change WF-No. DAWF-2021-0801 03_050602e-08/Page 1 of 16
®
= Registered trademark of BASF in many countries.

2 of 16 03_050602e-08 Kollidon® VA 64 / Kollidon® VA 64 Fine
1. Introduction Kollidon® VA 64 and Kollidon® VA 64 Fine are vinylpyrrolidone-vinyl acetate copoly

mers which are soluble both in water and in alcohols. They are 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 Kollidon® VA 64 is as matrix in amorphous
solid dispersions.
For further details that are beyond the scope of this leaflet, please consult the book,
“Kollidon® – Polyvinylpyrrolidone excipients for the Pharmaceutical Industry”
(03_030743e).
2. Technical properties Description

Kollidon® VA 64 and Kollidon® VA 64 Fine are spray dried polymer powders of a co
polymer derived from the monomers N-vinylpyrrolidone (NVP) and vinyl acetate (VAc).
The molar ratio of the monomers NVP and VAc in the copolymer is approx. 6 : 4.
The powders are white or slightly yellowish, have a faint characteristic odor and
practically no taste.
CAS-number
25086-89-9
Structural formula
(C6H9NO)n x (C4H6O2)m
Mr = (111.1)n x (86.1)m
n ≈ 1.2 m
Infrared spectrum
The infrared spectrum shown in Fig. 1 was obtained with a tablet of Kollidon® VA 64 in
potassium bromide. Arrows indicate where the spectrum differs from that of povidone.
Wavelength [μm]
4000 3000 2000 1500 1000 cm-1
100
80
Transmission [%]
60
40
20
0
2.5 3 4 5 6 7 8 9 10 12 13 14 15
Wavenumber [cm-1]
Fig. 1: Infrared spectrum of Kollidon® VA 64.
Molecular weight
The average molecular weight is usually expressed as a K value. The exact weight-
average 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 Kollidon® VA 64 and Kollidon® VA 64 Fine.
Solubility
Kollidon® VA 64 and Kollidon® VA 64 Fine 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
It is less soluble in:
ether, cyclic, aliphatic and alicyclic hydrocarbons
Viscosity
The values shown in Fig. 2 were determined at 25 °C in a capillary viscometer.
They represent typical values.
40
Isopropanol
30
Viscosity [mP·as]
20
Water
10
0
0 5 10 15 20
Concentration [%]
Fig. 2: Viscosity of Kollidon® VA 64 in water and isopropanol.
Bulk density
The bulk density of Kollidon® VA 64 Fine usually lies in the range of 0.08 – 0.15 g/ml.
The bulk density of Kollidon® VA 64 is above that one of Kollidon® VA 64 Fine and is
in the range of about 0.2 – 0.3 g/ml.
Particle size distribution

Typical values for the particle size of Kollidon® VA 64 and Kollidon® VA 64 Fine are
as follows:
Kollidon® VA 64 Kollidon® VA 64 Fine
>250 µm [%] max. 7% max. 2%
<50 µm [%] max. 35% min. 35%

Hygroscopicity
Kollidon® VA 64 and Kollidon® VA 64 Fine absorb only about one third of the quantity
of water absorbed by povidone, e.g. Kollidon® 30 (Fig. 3).
60
Water absorbed after 7 days [%]

Kollidon® 30
40
20
Kollidon® VA 64
0
0 20 40 60 80
Relative humidity [%]
Fig. 3: Hygroscopicity of Kollidon® VA 64 and Kollidon® 30.
3. Example application General

Copovidone has been used for decades in the pharmaceutical industry. Up to about
1975 it was marketed under the name of Luviskol® 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 Luviskol® VA 64 in pharmaceuticals.
Binder for tablets and granules

Kollidon® VA 64 and Kollidon® VA 64 Fine are 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 Kollidon® VA 64 and Kollidon® VA 64 Fine in this application is
the plasticity, which distinguishes the products from povidone (e.g. Kollidon® 30).
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

Kollidon® VA 64 and Kollidon® VA 64 Fine have been found to be excellent dry binders for
direct compression. Especially the Kollidon® VA 64 Fine 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 Kollidon® VA 64 are directly related to the compression force
used (see Table 1).

Table 1: Tablet properties related to the compression force

Compression Hardness Friability Porosity Disintegration
force time
[kp] [N] [%] [%] [s]
500 23.5 3.07 13.03 17
1000 55.8 0.98 6.87 58
1500 61.7 0.59 6.41 77
2000 65.7 0.49 5.33 90
2500 67.6 0.35 5.07 102
Kollidon® VA 64 and Kollidon® VA 64 Fine 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.
Table 2, for example, is suitable for direct compression. The literature contains
a large number of vitamin formulations with Kollidon® VA 64 (see “Generic Drug
Formulations” latest edition).
Table 2: 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%
Equipment
Rotary press: Korsch PH 100/6
Punch diameter: 8 mm, biplanar
Speed: 30 rpm
Tablet Properties:
Weight 250 mg
Hardness 157 N
Friability < 0.1%
The following examples show the properties of Kollidon® VA 64 Fine in formuations

for direct compression.

Table 3: Acetyl salycilic acid tablets 500 mg formulated with Kollidon® VA 64 Fine
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.
Equipment
Punch diameter: 12 mm beveled edge
Speed: 30 rpm
Tablet properties
Compression Tablet weight Hardness Disintegration Friability
Force
[kN] [mg] [N] [min:sec] [%]
6.8 772.3 81 04:13 0.4
10.7 777.5 140 08:25 0.2
16.5 768.0 187 15:03 < 0.1
Table 4: Indomethacin Tablets 50 mg formulated with Kollidon® VA 64 Fine

Indomethacin 50.0 mg
Di-tab 212.0 mg
Total 300.0 mg
The individual components were sieved through 0.8 mm. 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.
Equipment
Punch diameter: 8 mm, beveled edge
Speed: 30 rpm

Tablet properties
Force
5.6 301.9 62 00:22 0.16
9.7 304.5 101 00:36 < 0.1
15.9 304.0 158 01:12 < 0.1
Table 5: Atenolol Tablets 50 mg formulated with Kollidon® VA 64 Fine

Atenolol 50.0 mg
Ludipress® 135.7 mg
Aerosil 200 1.3 mg
Total 230.0 mg
The individual components were sieved through 0.8 mm. 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.
Equipment
Speed: 30 rpm
Tablet properties
Force
5.8 230.8 94 03:54 < 0.1
9.6 221.4 132 04:14 < 0.1
15.8 218.6 147 05:03 < 0.1

Wet granulation
Kollidon® VA 64 and Kollidon® VA 64 Fine 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. It 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 Kollidon® 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 (e.g. Kollidon® 25 or 30), Kollidon® VA 64 gives granules that have less
tendency to stick to the punches of the tabletting machine, when operating under
humid conditions. The binding power of Kollidon® VA 64 is comparable to that of
Kollidon® 25 and Kollidon® 30.
The formulations in Table 3 are typical of those used for producing tablets by wet
granulation (see “Generic Drug Formulations”, latest edition).
Table 6: 500 mg ampicillin tablets and 400 mg cimetidine tablets formulated

with Kollidon® VA 64
I Ampicillin trihydrate 500 g –

Cimetidine – 400 g
Corn starch 242 g 170 g
II Kollidon® VA 64 25 g 20 g
Isopropanol or water q.s. q.s.
III Kollidon® CL 15 g –
Magnesium stearate 10 g 3g
Aerosil 200 8g –
Mixture I is granulated with solution II, dried and sieved. The granules are then mixed
with III and pressed into tablets at low to medium pressure. Tablets obtained in the
laboratory had the following properties:
Weight 798 mg 601 mg

Diameter 16 mm 12 mm
Hardness 170 N 91 N
Disintegration in gastric juice 5 min 91 min
Friability 0.35% 0.5%

Dissolution (USP)
10 min: 62%
20 min: not 91%
30 min: tested 100%
Apart from its use in tablets, Kollidon® VA 64 can also be used to produce very stable
granules, e.g. for instant multivitamin drinks.
Roller compaction
Kollidon® VA 64 Fine 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 it 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.
The formulations in tables 4 and 5 are typical examples for Kollidon® VA 64 Formulation
using this technique.
Table 7: Allopurinol Tablets 300 mg formulated with Kollidon® VA 64 Fine

1. Allopurinol 100.0 mg
2. Ludipress® 50.0 mg
3. Kollidon® VA 64 Fine 10.0 mg
4. Kollidon® CL 6.0 mg
5. Magnesium stearate 1.0 mg
The compounds were compacted using a Gerteis compactor under the following
conditions
Roller compactor: Gerteis Type Mini-Pactor M1114
Roll width: 25 mm
Compression force: 2 kN/cm
Gap width: 3 mm
Tamping/feeding ratio: 120%
Roll speed: 2 rpm
Mesh sizes 1.25 mm
After compaction the material was blended for 10 minutes in a Turbula blender with the
remaining Ludipress® and the magnesium stearate and tableted as follows.
Allopurinol compacted formulation 167.0 mg
Ludipress® 133.0 mg
Total weight 301.0 mg
Equipment
Tablet press: Korsch PH 100/6
Compression force: 18kN
Compression speed: 30 rpm
Tablet properties:
force time
16.4 280.8 246 09:29 < 0.1
Table 8: Paracetamol Tablets 300 mg formulated with Kollidon® VA 64 Fine

1. Paracetamol Powder 500.0 mg
2. Avicel PH 102 131.0 mg

3. Kollidon® VA 64 Fine 45.0 mg
4. Kollidon® CL 21.0 mg
5. Aerosil 200 5.0 mg
6. Magnesium stearate 3.0 mg
The compounds 1 to 6 were compacted using a Gerteis compactor under the

following conditions.
Roller compactor: Gerteis Type Mini-Pactor M1114
Roll width: 25 mm
Compression force: 2 kN/cm
Gap width: 3 mm
Tamping/feeding ratio: 120%
Roll speed: 2 rpm
Mesh size: 1.25 mm
After compaction the material was blended for 10 minutes in a Turbula blender with
the remaining Kollidon® CL and the magnesium stearate and tableted as follows.
Paracetamol compacted formulation 695.0 mg
Total weight 705.0 mg
Equipment
Tablet press: Korsch PH 100/6
Compression force: 18 kN
Compression speed: 30 rpm
Tablet properties:
force
17.6 683.8 66 00:18
Film-coating
Kollidon® VA 64 forms films that are soluble at all pH values. They are less hygroscopic
and more elastic than those formed by povidone (e.g. Kollidon® 30). Nevertheless,
Kollidon® 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 poly
ethylene 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. Kollidon® 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.
Table 9: Sugar film coating (Accela Cota 24’’)

Suspension:
Sucrose 200 g
Kollidon® VA 64 50 g
Macrogol 4000 40 g
Sicovit® color lake 15 g
Sicovit titanium dioxide 30 g
Talc 50 g
Water ad 1,200 g
Continuously spray 1,200 g of this suspension onto 5 kg of tablet cores.

The spray conditions are as follows:
Inlet air temperature 45 °C

Outlet air temperature 36 °C
Nozzle diameter 0.8 mm
Spraying pressure 2.0 bar
Coating pan speed 15 rpm
Spraying time 50 min
Quantity of film former applied 4 mg/cm2

Table 10: Film coating with Hypromellose (Accela Cota 24“)

I Kollidon® VA 64 53 g
PEG 6000 12 g
HPMC 6 mPa·s 79 g
Water 732 g
II Sicovit® Titanium Dioxide 36 g
Sicovit® Iron Oxide Red 30 18 g
Talc 54 g
Water 216 g
Total 1200 g
Mix Solution I with Suspension II, pass through a disc mill.

The spray dispersion is calculated to be suitable for 5 kg of cores. The quantity of
film former applied is about 3 mg/cm2. The cores size was 9 mm, biconvex.
The coating process is performed using the following conditions:

Pan speed 12 rpm
Spraying rate [1 nozzle] 50 g/min
Spraying time 34 min
Quantity of applied film former 3.1 mg/cm²
Final drying at 60 °C 5 min
Subcoating
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 (e.g. Kollidon® CL) 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 Kollidon® 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 Kollidon® VA 64/cm2 is adequate.
Sugar-coating
Kollidon® 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, Kollidon® VA 64 helps not only
in the application of sugar coatings but also in the automation of the sugar-coating
process.
Sprays
Because of its good film-forming properties, Kollidon® VA 64 can also be used in
topical sprays. The formulation in Table 6 provides a typical example of a spray
bandage.
Table 11: Polidocanol wound spray

Polidocanol 5g
Lutrol E 400
®
20 g
Kollidon® VA 64 50 g
Ethocel 20 (Dow) 50 g
Ethyl acetate 675 g
Isopropanol 200 g
Fill this solution into spray cans together with the necessary quantity of propellant.
Amorphous Solid Dispersions

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, Kollidon® 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
Kollidon® 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 Kollidon® 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.

Amorphous Solid Dispersions by spray drying

For the manufacturing of solid dispersions using spray drying, it is essential that both
API and matrix polymer are soluble in a suitable volatile organic solvent. Kollidon®
VA 64 is soluble in a number of organic solvents (see section 2.5) at levels greatly
exceeding 10 % [w/w] while simultaneously retaining a low viscosity, which is crucial
for successful spray drying. An example of spray dried Kollidon® VA 64 from methanol
as a model solvent is shown in Figure 4.
5 µm
Figure 4: Spray dried Kollidon® VA 64 from methanol from a 10% solution.
The high solubility, when combined with the low viscosity of the achieved polymer/
API-solutions, as well as the strong thermodynamic and kinetic interactions with
poorly soluble drugs, make this polymer an outstanding matrix polymer for this
application.
Inhibition of the crystallization of APIs in liquid soft gel formulations

Another aspect to the challenge of poorly water-soluble drugs is the ability to retain
them in solution once dissolved, thereby maximizing absorption during the transit
time of the gastrointestinal tract. Compounds that expand this absorption window
are often called crystallization inhibitors as they retain drugs in a supersaturated
state for a prolonged time through what is known as the “parachute effect”. This
is in contrast with the “spring effect”, where drugs immediately recrystallize once
in contact with gastrointestinal media. Kollidon® VA 64 exhibits these effects when
utilized with poorly water-soluble compounds. In this case, the oral dose primarily
includes a hard or softgel capsule where Kollidon® VA 64 is dissolved in hydrophilic
fill formulations such as low molecular weight polyethylene glycols (PEGs), such as
Kollisolv® PEG 400.
With Kollidon® VA 64, it is possible to prevent recrystallisation and to achieve

a “Parachute Effect” in both low pH stomach conditions and high pH intestinal
conditions. Under stomach conditions, this is shown in Figure 5 for the model poorly
soluble drug Danazol with Kollidon® VA 64 used at 5% w/w in a PEG 400 liquid
fill. The effect is compared with known crystallization inhibitor Kollidon® 12 PF and
solubilizer Kolliphor RH 40, which exhibits a spring effect.
Drug dissolution was determined using a Pion Inform system with 50 ml buffer system
of pH 2.0 and pH 6,8, respectively, and 0.5 ml of liquid formulation representing the
filling volume of a soft gel capsule.
Danazol pH 2 PEG 400

250 Danazol pH 2 PEG 400 + 5% Kollidon® 12 PF
Danazol pH 2 PEG 400 + 5% Kollidon® VA 64
Danazol pH 2 PEG 400 + 5% Kolliphor® RH 40
API concentration [µg/ml]

200
150
100
50
0
0 5 10 15 20 25 30
Time [min]
Figure 5: Parachute effect of Kollidon® VA 64 under stomach conditions (pH = 2).
Under gastric, acidic conditions, the effect is self-evident, showing Kollidon® VA 64

with a significantly improved absorption window. Under intestinal conditions, the
same effect is achieved, as shown in Figure 6.
250
Danazol pH 6.8 PEG 400
Danazol pH 6.8 PEG 400 + 5% Kollidon® 12 PF
200
API concentration [µg/ml]
Danazol pH 6.8 PEG 400 + 5% Kollidon® VA 64

Danazol pH 6.8 PEG 400 + 5% Kolliphor® RH 40
150
100
50
0
0 5 10 15 20 25 30
Time [min]
Figure 6: Parachute effect at pH 6.8 under intestinal conditions.
Under intestinal conditions, a classic spring model for Kolliphor® RH 40 is observed,

while very little effect of Kollidon® 12 PF is noted. However, Kollidon® VA 64 shows a
significantly improved absorption window.
09_130829e-03 November 2017 Page 16 of 16 Pluronic® FT PE 6100
4. Handling & Safety Please refer to the individual material safety data sheet (MSDS) for instructions on safe
and proper handling and disposal. Material safety data sheets are sent with every
consignment. In addition they are available on BASF RegXcellence®* or from your
local BASF sales representative.
5. Product specification The current version of the product specification is available on BASF RegXcellence® *
or from your local BASF sales representative.
6. Regulatory & Quality Please refer to the individual document quality & regulatory product information (QRPI)
which is available on BASF WorldAccount, RegXcellence® *, and from your local sales
representative The QRPI covers all relevant information including retest dates,
and storage conditions.
7. Toxicology The safety of the polymer in Kollidon® grades as pharmaceutical excipient in film
coating of solid oral dosage forms is supported by a comprehensive non-clinical
study. A summary of the study is available on BASF WorldAccount, RegXcellence® *
or from your local sales representative. A detailed report can be shared as part of a
non-disclosure agreement.
* https://worldaccount.basf.com, RegXcellence (https://mypharma.basf.com/)
8. P
RD and Article numbers
PRD-No.* Product name Article numbers Packaging
30499395 Kollidon® VA 64 50131775 35 kg PE drum with PE liner

30499398 Kollidon® VA 64 50131776 35 kg PE drum with PE liner
30239644 Kollidon® VA 64 Fine 57071976 15 kg Cardboard box with PE liner aluminium laminated
* BASF’s commercial product number.
9. Publications http://pharmaceutical.basf.com/en.html
Disclaimer his document, or any answers or information provided herein by BASF, does not
T
constitute a legally binding obligation of BASF. While the descriptions, designs, data
and information contained herein are presented in good faith and believed to be
accurate, it is provided for your guidance only. Because many factors may affect
processing or application/use, we recommend that you make tests to determine
the suitability of a product for your particular purpose prior to use. It does not relieve
our customers from the obligation to perform a full inspection of the products upon
delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED
OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS,
DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE
INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE
DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A
PART OF OUR TERMS AND CONDITIONS OF SALE.
June 2021
BASF – Nutrition & Health – www.pharma-ingredients.basf.com

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Technical Information

Copovidone Ph. Eur., USP, Copolyvidone JPE.

1. Introduction Kollidon® VA 64 and Kollidon® VA 64 Fine are vinylpyrrolidone-vinyl acetate co­poly­

2. Technical properties Description

Fig. 2: Viscosity of Kollidon® VA 64 in water and isopropanol.

Particle size distribution

Water absorbed after 7 days [%]

Fig. 3: Hygroscopicity of Kollidon® VA 64 and Kollidon® 30.

3. Example application General

Binder for tablets and granules

Dry Binder for direct compression

Table 1: Tablet properties related to the compression force

Kollidon® VA 64 and Kollidon® VA 64 Fine can be added to materials such as sorbitol,

Table 2: Ascorbic acid chewable tablets 100 mg

The following examples show the properties of Kollidon® VA 64 Fine in formuations

10.7 777.5 140 08:25 0.2

16.5 768.0 187 15:03 < 0.1

Table 4: Indomethacin Tablets 50 mg formulated with Kollidon® VA 64 Fine

9.7 304.5 101 00:36 < 0.1

15.9 304.0 158 01:12 < 0.1

Table 5: Atenolol Tablets 50 mg formulated with Kollidon® VA 64 Fine

9.6 221.4 132 04:14 < 0.1

15.8 218.6 147 05:03 < 0.1

Table 6: 500 mg ampicillin tablets and 400 mg cimetidine tablets formulated

I Ampicillin trihydrate 500 g –

Weight 798 mg 601 mg

Friability 0.35% 0.5%

Table 7: Allopurinol Tablets 300 mg formulated with Kollidon® VA 64 Fine

Table 8: Paracetamol Tablets 300 mg formulated with Kollidon® VA 64 Fine

2. Avicel PH 102 131.0 mg

The compounds 1 to 6 were compacted using a Gerteis compactor under the

Table 9: Sugar film coating (Accela Cota 24’’)

Continuously spray 1,200 g of this suspension onto 5 kg of tablet cores.

Inlet air temperature 45 °C

Table 10: Film coating with Hypromellose (Accela Cota 24“)

Mix Solution I with Suspension II, pass through a disc mill.

The coating process is performed using the following conditions:

Table 11: Polidocanol wound spray

Amorphous Solid Dispersions

For both technologies, Kollidon® VA 64 has proven its suitability to generate

Amorphous Solid Dispersions by melt extrusion

A number of product parameters have been optimized to minimize degradation of

The resulting intermediate extrusion products can be processed downstream by

Amorphous Solid Dispersions by spray drying

Inhibition of the crystallization of APIs in liquid soft gel formulations

With Kollidon® VA 64, it is possible to prevent recrystallisation and to achieve

Danazol pH 2 PEG 400

API concentration [µg/ml]

Figure 5: Parachute effect of Kollidon® VA 64 under stomach conditions (pH = 2).

Under gastric, acidic conditions, the effect is self-evident, showing Kollidon® VA 64

Danazol pH 6.8 PEG 400 + 5% Kollidon® VA 64

Figure 6: Parachute effect at pH 6.8 under intestinal conditions.

Under intestinal conditions, a classic spring model for Kolliphor® RH 40 is observed,

* https://worldaccount.basf.com, RegXcellence (https://mypharma.basf.com/)

30499395 Kollidon® VA 64 50131775 35 kg PE drum with PE liner

* BASF’s commercial product number.

BASF – Nutrition & Health – www.pharma-ingredients.basf.com

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1. Introduction Kollidon® VA 64 and Kollidon® VA 64 Fine are vinylpyrrolidone-vinyl acetate copoly