Kollicoat IR
Kollicoat IR
Kollicoat IR
March 2008
Supersedes issue dated March 2007
EMP 030724e-05/Page 1 of 12
®=R
egistered trademark of BASF SE olyvinyl alcohol-polyethylene glycol graft copolymer for
P
instant-release coatings and quick-dissolving formulations
Pharma
Ingredients
& Services
EMP 030724e-05 March 2008 Page 2 of 12 Kollicoat IR
Contents
Page
1. Introduction 3
1.1 General 3
3.1 Applications 7
4. Typical formulations 8
5. Storage conditions 12
6. Stability 12
7. Toxicology 12
8. PBG-No. 12
9. PRD-No. 12
10. Packaging 12
EMP 030724e-05 March 2008 Page 3 of 12 Kollicoat IR
1. Introduction
1.1 General Kollicoat IR is a polyvinyl alcohol-polyethylene glycol graft copolymer that is
freely soluble in water. It is used mainly for the production of instant-release
coatings for tablets.
2.2 Physicochemical properties As a result of its structure, the polymer dissolves very readily in acidic, neutral
and alkaline aqueous media. Such aqueous solutions have a comparatively low
viscosity.
Solubility As a result of its structure, the polymer dissolves very readily in acidic, neutral
and alkaline aqueous media. Such aqueous solutions have a comparatively
low viscosity. Solutions of Kollicoat IR with concentrations of up to 40% can be
prepared in water and aqueous systems, e.g. weak acids or alkalis. Solutions
of up to 25% can be prepared in a 1:1 ethanol-water mixture. Due to colloidal
silica, aqueous solutions of Kollicoat IR are slightly turbid. Its solubility in non-
polar solvents is low, and it can only be dispersed in these..
Film formation An aqueous solution of Kollicoat IR is cast on a smooth surface. When the water
has evaporated, a clear colourless flexible film remains (see 2.4, Film properties).
Specification See separate document: “Standard Specification (not for regulatory purposes)”
available via BASF’s WorldAccount: https://worldaccount.basf.com (registered
access).
Pharmacopoeias A draft Ph.Eur. monograph with the title „Macrogol Poly(Vinyl Alcohol) Grafted
Copolymer“ will be published in PharmEuropa 20/3.
EMP 030724e-05 March 2008 Page 5 of 12 Kollicoat IR
Viscosity Though the viscosity of aqueous solutions of Kollicoat IR increases with the
polymer concentration, it remains much lower than that of equivalent solutions
of, for instance, cellulose derivatives.
Surface activity Kollicoat IR reduces the surface tension of water. This makes aqueous solutions
easy to spray, and the spray droplets exhibit good wetting behaviour on the tab
let surface.
2.4 Film properties Kollicoat IR forms clear colourless films that are enormously flexible and dissolve
very rapidly in water. Kollicoat IR films are not tacky, have a high pigment binding
capacity and can readily be printed.
Kollicoat IR solutions for spraying onto tablets can be applied with a high
solids content, which greatly reduces the coating time and minimises costs.
3.2 Processing notes Because of the high flexibility of Kollicoat IR films, it is not necessary to add a
plasticizer.
Since Kollicoat IR has surfactant properties and can act as a protective colloid, it
prevents the aggregation of the pigment particles and ensures that the pigment is
evenly distributed over the tablet core.
The great elasticity of Kollicoat IR ensures that it does not crack on the tablets when
they are exposed to different humidity conditions in storage, even when the cores
contain high amounts of disintegrants or powerful swelling agents such as HPMC,
xanthan or alginate which are frequently used in sustained release tablets.
The coating can be applied in all the usual coaters, e.g. horiz ontal drum coaters,
fluidised bed coaters, immersion sword coaters, and coating pans under the usual
conditions for aqueous solutions.
The product can very easily be cleaned off equipment with warm or cold water.
EMP 030724e-05 March 2008 Page 8 of 12 Kollicoat IR
4. Typical formulations
4.1 Propranolol instant-release film-coated tablets
Composition of the tablets 40 mg propranolol HCl; 97.5 mg Ludipress®; 12.5 mg Kollidon® VA 64;
97.5 mg Avicel PH 102; 2.5 mg magnesium stearate
Composition of the spray The formulation is designed for 250 kg of tablets (tablet weight 250 mg;
suspension diameter 9 mm)
Polymer solution
Kollicoat IR 6,080 16.0
Water 24,320 64.0
Pigment suspension
Talc 1,710 4.5
Titanium dioxide 1,140 3.0
Sicovit® Red 30 570 1.5
Water 4,180 11.0
38,000 100
Pigment suspension:
Vigorously stir talc, Sicovit Red 30 and titanium dioxide into the specified quantity
of water and homogenise in a corundum disk mill.
Spray suspension:
Stir the pigment suspension into the polymer solution. To avoid sedimentation
during the spraying process, the mixture must be continuously stirred.
Additional glass coating If a certain appearance of the tablet is needed 5 wt% polyethylene glycol 6 000
should be dissolved in water and sprayed after the spray suspension.
The achieved weight gain should be between 0.3-0.6 mg/cm2.
EMP 030724e-05 March 2008 Page 9 of 12 Kollicoat IR
Machine parameters
Tablet properties
Composition of the spray solution The formulation is designed for 5 kg of tablets (weight 330 mg; diameter 9 mm)
Polymer solution
Kollicoat IR 100 19.2
Water 264 50.8
Pigment suspension
Talc 37.4 7.2
Titanium dioxide 18.6 3.6
Water 10.0 19.2
430 100
Pigment suspension:
Vigorously stir talc and titanium dioxide into the specified quantity of water and
homogenise in a co-rundum disk mill.
Spray suspension:
Stir the pigment suspension into the polymer solution. To avoid sedimentation
during the spraying process, the mixture must be continuously stirred.
Additional glass coating If a certain appearance of the tablet is needed 5 wt% polyethylene glycol 6 000
should be dissolved in water and sprayed after the spray suspension. The
achieved weight gain should be between 0.3-0.6 mg/cm2.
Machine parameters
Tablet properties
Composition of the 49% acetaminophen, fine powder; 49% sorbitol; 2% aspartame; 0,06% aroma
powder mixture
Granulation solution
Kollicoat IR 27.0 15.0
Water 153.0 85.0
180 100
Preparation of the Stir the Kollicoat IR into the specified quantity of water until it has dissolved.
binder solution
Manufacture of the granules Mix the components of the powder mixture for 10 min
(Stephan mixer Type UMC 5 Electronic).
Apply the Kollicoat IR solution in a fine spray, keeping the mixture in motion.
Force the moist mass first through a 3-mm sieve, then a 1-mm sieve.
Dry the moist granules and force them through a 1-mm sieve.
6. Stability At least 2 years in the original sealed containers at room temperature.
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.
March 2008
BASF SE - Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com