Technical Information Kollicoat® IR White

January 2008
Supersedes issue dated April 2007

EMP 040901e-08/Page 1 of 12

®=R
 egistered trademark of BASF SE Ready-to-use coating for instant-release dosage forms

Pharma
Ingredients
& Services
EMP 040901e-08 January 2008 Page 2 of 12 Kollicoat IR White

Contents
Page

1. Intro­duc­tion 3

1.1 General 3

1.2 Structural formula 3

1.3 Physical form 3

2. Specification and prop­er­ties 4

2.1 Chemical nature 4

2.2 Physicochemical properties 4

2.3 Properties of aqueous solutions 4

2.4 Film properties 6

3. Application and processing 6

3.1 Applications 6

3.2 Incompatibilities 7

3.3 Processing notes 7

4. Typical formulations 8

4.1 Aspirin instant-release film-coated tablets 8

4.2 Propranolol instant-release film-coated tablets 9

4.3 Vitamin C instant-release film-coated tablets 10

5. Storage conditions 11

6. Stability 11

7. Toxicology 11

8. PBG, PRD Nos. 11

9. Packaging 11

10. Note 11
EMP 040901e-08 January 2008 Page 3 of 12 Kollicoat IR White

1. Introduction
1.1 General  ollicoat IR White is a ready-to-use coating system based on Kollicoat IR
K
(polyvinyl alcohol‑polyethylene glycol graft copolymer) that is very readily
redispersible in water. The extremely rapid redispersibility is due to the innovative
manufacture of this combination of pigments and polymers.
It is used primarily to manufacture film coatings that dissolve in the gastric juices
(instant-release coatings).

1.2 Structural formula The recipe is based mainly on the highly flexible film former Kollicoat IR, which
has the following structure:

Composition
Kollicoat IR 45%-74%
Kollidon® VA 64 5%-10%
Titanium dioxide 10%-20%
Kaolin 10%-20%
Sodium lauryl sulfate 1%- 5%

1.3 Physical form Kollicoat IR is a white to off-white, free-flowing powder.

EMP 040901e-08 January 2008 Page 4 of 12 Kollicoat IR White

2. Specifications and properties

2.1 Chemical nature Owing to the special manufacturing process for Kollicoat IR White, the fine
pigments are embedded in a polymer matrix and therefore unable to separate
or agglomerate. The spray-dried powder form and the particle size of approx.
200µm ensure good flowability and redispersibility in water.

2.2 Physicochemical properties Kollicoat IR White can easily be dispersed in water. The viscosity of aqueous
dispersions is relatively low (see 2.3 Properties of aequeous suspensions)

Film formation An aqueous dispersion of Kollicoat IR White is cast on a smooth surface. When
the water has evaporated, a clear colourless flexible film remains (see 2.4, Film
properties).

Specification Test parameter Requirement

Identity (IR) Must comply
Loss on drying (Ph.Eur 2.2.32 105 °C vacuo) max. 5.0%
pH-value ( Ph.Eur 2.2.3; 20% w/w solution in water) 5.0 – 8.5
Viscosity (Brookfield, 20% w/w solution, 50 – 250 mPas
sp 2 100 rpm, 23°C
Dispersibility in water max. 2%
(20% w/w residue on 100 µm filter)
Sulphated ash (Ph.Eur 2.4.1; 15 g) 24 – 38%
Acetate (GC) max. 15 000
Vinyl acetate (GC) max. 100 ppm
Residual solvents (Ph.Eur, USP)
Methanol max. 3000 ppm
Ethylene glycol
1,4 dioxane max. 100 ppm
Methyl acetate max. 1000 ppm
Ester value (Ph.Eur 2.5.2) 20 – 70 mg KOH/g
Microbial status (Ph.Eur 5.1.4, cat 3A) Must comply

Analytical procedures (non compendial methods) are supplied upon request.

Pharmacopoeias No monograph on Kollicoat IR has yet been registered in any of the main
pharmacopoeias (USP, EP, JP). However, a number of products are currently
being tested by the regulatory authorities in Europe, USA und Japan.
The remaining components of the system conform to the corresponding
monographs in EP, USP and JP.

2.3 Properties of aqueous suspensions

Viscosity The viscosity of aqueous dispersions of Kollicoat IR White increases with the
polymer concentration, but remains very low.
EMP 040901e-08 January 2008 Page 5 of 12 Kollicoat IR White

Viscosity of aqueous Kollicoat IR White suspensions as a function of polymer

concentration (at 23°C)

Viscosity of Kollicoat IR White suspensions as a function of solids concentration

Viscosity of various spray suspensions (20% w/w, 23°C)

Surface tension The surface tension of a 20 % Kollicoat IR White suspension is very low
(39.5 mN/m). Good wetting and spreadability are therefore achieved even on
lipophilic surfaces.
EMP 040901e-08 January 2008 Page 6 of 12 Kollicoat IR White

2.4 Film properties Kollicoat IR White forms smooth, white, highly flexible films that disperse very
rapidly in water. Kollicoat IR White films are not tacky and can be readily printed.

Elongation at break of various ready-to-use instant-release films (23°C, 58% r. h.)

Adhesiveness Kollicoat IR White films adhere extremely well to tablet surfaces of varying
lipophilic character.

Coating engravings The very low viscosity and excellent wetting and spreading properties ensure
that even fine engravings are uniformly coated and no bridging occurs.

3. Application and processing

3.1 Applications Kollicoat IR White can be used in all applications where a readily redispersible,
flexible coating is required.
• Instant-release coating - P
 rotects against unpleasant taste and odor,
improves appearance, makes tablet easier to
swallow, gives distinctive coloring, protects active
ingredients (prevents interaction).

The special advantages of Kollicoat IR White are high flexibility, low viscosity and
rapid manufacture of coating suspensions.

Kollicoat IR White suspensions for spraying on to tablets can be applied with a

high solids content, which greatly reduces the coating time and minimizes costs.

The high flexibility of the films ensures that they do not crack on the tablets.

Kollicoat IR White can be combined with water-soluble dyes, lakes or iron

oxides to obtain a particular shade. Water-soluble dyes and dispersible color
concentrates are especially easy to use.

Kollicoat IR White can also be used together with ready-mix colors (e.g.
SepispersTM Dry) to make colored tablets.
EMP 040901e-08 January 2008 Page 7 of 12 Kollicoat IR White

3.2 Incompatibilities Ibuprofen can lead to discoloration of Kollicoat IR White coatings when film-coated
tablets are stored under light. This yellowing effect is caused by an incompatibility
of ibuprofen with kaolin contained in Kollicoat IR White. For ibuprofen tablets we
recommend to use Kollicoat IR and titanium dioxide as pigment.

3.3 Processing notes Because of the high flexibility of Kollicoat IR White films, it is not necessary to
add a plasticizer.

A spray suspension is conveniently prepared as follows:

Stir Kollicoat IR White into water and redisperse. The mixer speed should be
adjusted so that little or no foam is produced. After stirring for 15 min, Kollicoat
IR White is ready for further processing.

The figures clearly illustrate the simple redispersion of Kollicoat IR White.

On account of its much lower viscosity, Kollicoat IR White can be processed

in spray suspensions of much higher concentration than other ready-to-use
instant-release formulations. This greatly shortens the spraying and processing
time in the manufacture of film-coated tablets. Suspensions with a solids
concentration of 15 – 30% can be processed without problem.

The high elasticity of Kollicoat IR White ensures that it does not crack on the
tablets when they are exposed to varying humidity during storage.

The coating system can be applied on all the usual coaters, e.g. horizontal drum
coaters, fluidized bed coaters, immersion sword coaters, and coating pans,
under the usual conditions for aqueous solutions.

The following conditions have produced good results in numerous trials:

Inlet air temperature: 50-80°C
Outlet air temperature: 30-50°C
Atomizing pressure: 2-4 bar
Temperature of spray suspension: 20-70°C

Cleaning The product can very easily be cleaned off equipment with warm or cold water.
EMP 040901e-08 January 2008 Page 8 of 12 Kollicoat IR White

4. Typical formulations
4.1 Aspirin instant-release Formulation No. P053/01
film-coated tablets

Composition of tablets 100 mg acetylsalicylic acid, 148.5 mg Ludipress® LCE, 50 mg Avicel® PH 102,
1.5 mg magnesium stearate

Composition of spray suspension The formulation is designed for 6 kg of tablets (tablet weight 300 mg, diameter
9 mm)

Weight [g] Proportion [%]

Spray suspension
Kollicoat IR White 209 20
Water 836 80
1 045 100

Preparation of spray suspension Spray suspension:

Stir the Kollicoat IR White into the specified quantity of water. After 15 min the
spray suspension is ready for further processing.

Machine parameters Coating machine Accela-Cota drum coater

(24 inch)
Batch size 6 kg
Inlet air temperature 60°C
Outlet air temperature 36°C
Product temperature 35°C
Outlet air flow 410 m3/h
Atomizing pressure 2 bar
Forming air pressure 1 bar
Number of spray nozzles 1
Spraying rate 30 g/min
Spraying time 35 min
Final drying 60°C / 4 min
Quantity applied 5 mg/cm2 solids

Tablet properties Core Film-coated tablet

Appearance white white
Hardness 67 N 75 N
Friability 0% 0%
Disintegration time 3:17 [min:s] 3:29 [min:s]
EMP 040901e-08 January 2008 Page 9 of 12 Kollicoat IR White

4.2 Propranolol instant-release Formulation No. P053/02

film tablets

Composition of tablets
40 mg propranolol-HCl, 97.5 mg Ludipress, 12.5 mg Kollidon VA 64, 2.5 mg
magnesium stearate, 97.5 mg Avicel PH 102

Composition of spray suspension The formulation is designed for 250 kg of tablets (tablet weight 250 mg,
diameter 9 mm)

Weight [g] Proportion [%]

Polymer suspension
Kollicoat IR White 7 755 18.80
Water 25 000 60.61

Pigment suspension
Indigotin lake, E 132 495 1.20
Water 8 000 19.39
41 250 100.00

Preparation of spray suspension Polymer suspension:

Stir the Kollicoat IR White into the specified quantity of water.

Pigment suspension:
Add the indigotin lake to the specified quantity of water and homogenize with a
high-shear mixer, e.g. Ultra-Turrax.

Spray suspension:
Stir the pigment suspension into the polymer suspension.

Machine parameters Coating machine Driacoater drum

coater,Type 900
Batch size 250 kg
Inlet air temperature 70°C
Outlet air temperature 45°C
Product temperature 47°C
Air flow 4 600 m3/h
Atomizing pressure 4 bar
Number of spray nozzles 6
Spraying rate 700 g/min
Spraying time 60 min.
Final drying 60°C / 5 min
Quantity applied 3.0%

Tablet properties Core Film-coated tablet

Appearance white blue
Hardness 94 N 112 N
Friability 0% 0%
Disintegration time 5:51 [min:s] 6:02 [min:s]
Drug release 10 min: 51% 10 min: 53%
20 min: 99% 20 min: 99%
EMP 040901e-08 January 2008 Page 10 of 12 Kollicoat IR White

4.3 Vitamin C instant-release Formulation No. P053/03

film tablets

Composition of tablets 103.1 mg Vitamin C 97, 180.0 mg Ludipress,

14.4 mg Kollidon VA 64, 5.0 mg Kollidon CL,
2.5 mg magnesium stearate

Composition of spray suspension The formulation is designed for 1 kg of tablets (tablet weight 300 mg, diameter
8.5 mm)

Weight [g] Proportion [%]

Polymer suspension
Kollicoat IR White 25.872 18.48
Water 105.000 75.00

Pigment suspension

Kollicoat IR White 1.764 1.26

Sicovit Red 30 1.764 1.26

Water 5.600 4.00

140.000 100.00

Preparation of spray suspension Polymer suspension:

Stir the Kollicoat IR White into the specified quantity of water.

Pigment suspension:

Stir the Kollicoat IR White into the specified quantity of water. Then stir in the color
pigment and homogenize with a high-shear mixer, e.g. Ultra-Turrax.

Spray suspension:

Stir the pigment suspension into the polymer suspension.

Machine parameters Coating machine Hi-Coater

(Freund Industrial Co.)
Batch size 1 kg
Inlet air temperature 54 – 57°C
Outlet air temperature 34 – 35°C
Atomizing pressure 1.5 bar
Number of spray nozzles 1
Spraying rate 5.2 – 5.4 g/min
Spraying time 28 min
Final drying 8 min
(outlet air temp. 34 –
40°C)
Quantity applied 3.15%

Tablet properties Core Film-coated tablet

Appearance white red
Hardness 150 N 180 N
Friability 0% 0%
Disintegration time 5:18 [min:s] 5:06 [min:s]
EMP 040901e-08 January 2008 Page 11 of 12 Kollicoat IR White

5. Storage conditions Store at room temperature.

6. Shelf life At least 3 years in the original sealed containers at room temperature.

7. Toxicology A complete toxicological characterization of Kollicoat IR White for application as

a pharmaceutical adjuvant has been carried out.

A summary of the available data is available on request under Secrecy Agreement.

8. PBG, PRD Nos. PBG: 10 581 609, PRD: 30235578

9. Packaging 120 l plastic drum with PE liner, 30 kg capacity.

10. Note This document, or any answers or information provided herein by BASF, does
not 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.

January 2008
EMP 040901e-08 January 2008 Page 12 of 12 Kollicoat IR White

BASF SE - Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com