Kollicoat® IR White

Instant white for instant release coating.

2 The Preface
Coating tablets is now
standard practice for
solid dosage forms in
pharmaceuticals and Not only can tablet coating en-
dietary supplements. hance shelf life, but research
studies show that consumers
prefer to swallow a coated tablet
rather than an uncoated one. The
coating color also enables strong
product and brand identity to be
achieved and helps patients to
Trademarks are owned ■ Protection of active ingre-
by BASF Aktiengesellschaft dients against light and
moisture
■ The possibility of printing a
logo, dosage etc. on the tablet
for easier identification
identify the right medication. OTC
coated tablets are perceived by
consumers to be more effective
than uncoated tablets because
their appearance is similar to that
of prescription drugs. There are
also other reasons for applying a
film coating:
■ Reduction of friability, which
reduces dust formation during
packaging
■ Increased mechanical stability
during manufacture, packa-
ging and transportation
■ Attractive coatings improve
the appearance of tablets and
increase patient compliance

In most cases coating polymers
cannot be used alone in solid oral
dosage forms such as tablets,
pellets or granules, but have to
be used together with further
additives. As it is much easier
to handle just one mixture of
polymers and additives, there is
a clear trend toward so-called
coating systems. These coating
systems comprise polymers, plas-
ticizers, coloring agents and other
necessary excipients; these can
be stirred into water or an organic
solvent using a low-shear mixer
to produce a suspension for film
coating of tablets.
Kollicoat® IR White now combi-
nes the advantages of Kollicoat®
IR with an innovative method of
manufacture. Kollicoat® IR White
is a rapid dispersible coating sys-
tem which produces a coating
suspension within 10 to 15 minu-
tes. Compared with hydroxypro-
pyl methylcellulose (HPMC), Kolli-
coat® IR has several advantages:
The Preface 3
■ Higher pigment loading capa-
city facilitates coloring of the
dosage form
■ Low viscosity allows for higher
concentrations of solids and
significantly reduces the
processing time
■ High solubility in water results
in easier cleaning of the
equipment
■ High flexibility of the polymers
allows engraved tablets to be
coated with high quality results
Based on
Kollicoat® IR
expertise
4 The Product

Product form:

The basis of Kollicoat® IR White

is Kollicoat® IR, which is a graft
copolymer consisting of 75 %
polyvinyl alcohol units and 25 %
polyethylene glycol units with a
molecular weight of approxima-
tely 45,000 Daltons. Further addi-
tives in Kollicoat® IR White include
copovidone, titanium dioxide,
kaolin, silicon dioxide and sodium
lauryl sulfate.

Pharmacopoeia:

To date, no monographs for

Kollicoat® IR have been published
in any of the major pharmacopo-
eias; however, several products
have been submitted for approval
to the authorities e. g. in Europe,
USA and Japan. The other ingre-
dients comply with the respective
monographs in the European
Pharmacopoeia, United States
Pharmacopoeia and the Japa-
nese Pharmaceutical Excipients.

Faster dispersions
with Kollicoat® IR White
While Kollicoat® IR can be applied
as a ready-to-use clear coat,
Kollicoat® IR White is a white
coating system which can be
sprayed from aqueous suspen-
sions to produce white tablets.
Further to this it may also be used
together with a color premix (e. g.
Sepisperse™ Dry) to produce
colored tablets.
The Application 5
In its function as an
instant release film coating,
Kollicoat® IR White:
■ Protects against unpleasant
taste or odor
■ Covers ingredients’ colors
■ Improves the appearance
of the dosage form
■ Makes tablets easier to
swallow and increases
patient compliance
■ Provides an excellent Trademark not owned by BASF:
basis for printing tablets Sepisperse™
■ Protects light-sensitive
active ingredients
■ Produces a distinctive
appearance (coloring)
6 The Formulation

Kollicoat® IR White can Due to the low viscosity of poly-

be dispersed much
quicker than HPMC-
based coating systems.
The processing of Kollicoat® IR
White is an easy two-step
procedure:
1. Weighing of the necessary
amount of coating system
and water
2. Stirring of the coating
suspension for 10 to 15
minutes with a low-shear
mixer
mer solutions, concentrations
of solids of up to 30 % can be
prepared and sprayed easily.
The coating can be applied in
all usual coaters, e. g. horizontal
drum coaters, fluidized bed coat-
ers, immersion sword coaters
and coating pans under normal
conditions for aqueous solutions.

0 min
 The Formulation 7

The product can be very easi- Kollicoat® IR White shows

ly cleaned off equipment with superior mechanical properties
The following conditions have warm or cold water. compared to competitive
been used successfully in products.
numerous trials:

■ Inlet air temperature:

50–80 °C (122–176 °F) Elongation at break 23 °C/58 % r. h.
■ Outlet air temperature:
30–50 °C (86–122 °F)
■ Atomizing pressure: 45 41.4
2–4 bar
40
elongation at break [%]

35
30
25
20
15
10
5 2.6
0.9
0

Kollicoat® IR Main compe- Main compe-

White titor A titor B

10 min
8 The Example

Propranolol HCl film-coated tablets with a 3.4 % coating level

Composition of the spray suspension:

The formulation is designed for a batch size of 7 kg of tablets
(tablet weight 300 mg; diameter 9 mm).

Kollicoat® IR White 231 g 17.6 %

Sepisperse™ Dry 5520 Red 30 g 2.4 %
Water 1,044 g 80.0 %

Machine parameters:

Coating machine Accela Cota 24-inch, perforated drum coater

Batch size 7 kg
Inlet air temperature 60 °C/140 °F
Outlet air temperature 38–43 °C/100–110 °F
Product temperature 39–41 °C/102–106 °F
Airflow 220 m3/h
Atomizing pressure 2 bar
Pattern air pressure 1 bar
Number of spray nozzles 1
Spraying rate 35 g/min
Spraying time 37 min
Final drying 60 °C/140 °F/5 min
Quantity applied 3.4 %

Tablet properties:

Core Film-coated tablet

Appearance White Pink

Hardness 89 N 106 N
Friability 0% 0%
 The Example 9

Preparation of the spray As shown in the figure below,

suspension: Kollicoat® IR White shows
excellent properties in coating
Kollicoat® IR White is stirred into engraved tablets. No bridging can
the specified amount of water in be observed.
which Sepisperse™ Dry had been
dispersed. In order to prevent
foam formation, a stirrer with
good mixing properties at low/
medium rotation speed should
be used. The spray suspension
should be stirred during the
spraying process to avoid
sedimentation of the pigments.

500 µm

SEM of a film-coated tablet

(letter A)

Examples for colorants approved worldwide.

Color Name E-Number CAS Color index

The following colorants have

been successfully tested together Blue FD&C No. 1 132 860-22-0 73015
with Kollicoat® IR White as a Red Sicovit® Red 172 1309-37-1 77491
basis: Alura red/ 129 25956-17-6 16035
FD & C red 40
Carmin 120 – 75470
Yellow Sicovit® Yellow 172 51274-00-1 77492
Sunset yellow/ 110 2783-94-0 15985
FD & C yellow No. 6
Brown Sicovit® Brown 172 12227-89-3+ 77491+77499
(yellow and black) 12227-89-3
Green Fast Green/ – 2353-45-0 42053
Trademark not owned by BASF: FD & C green No. 3
Sepisperse™ Green S 142 – 44090
10 The Overview
So far, the polymer ■ Aqueous HPMC solutions have
most frequently used in a high viscosity. Thus, HPMC
instant release coating needs to be processed in low
systems is HPMC. concentrated aqueous
However, the use solutions. This gives rise to
of HPMC for instant long spraying processes and
release film coating high energy consumption for
has certain drawbacks. the evaporation of water.
These are primarily: ■ HPMC is a brittle polymer that
does not form flexible films
without high amounts of plasti-
cizer. The use of plasticizers
can cause a number of
problems.
■ The spreading behavior of
HPMC is poor, which makes it
very difficult to coat engraved
tablets.
Based on these weaknesses,
that also apply to other polymers
currently used for film coating,
there is a strong demand for a
new excipient in this application
field: Kollicoat® IR White.

The processing of Kollicoat® IR
White is an easy two-step
procedure:
1. Weighing of the necessary
amount of coating system
and water
2. Stirring of the coating
suspension for 10 to 15
minutes with a low-shear
mixer
The major advantages of the
product are:
■ Very quickly dispersible in
water
■ Due to the special method of
production used, films are very
homogeneous and smooth
■ As the pigments are embedded
in the polymer, no segregation
can occur
■ The system is miscible with
colorants such as iron oxides
or lakes to give colored
coatings
Please write Please
Title/Name
apply
in block letters.
postage
Thank you. Department stamp.
The Summary 11
Company
Address
Town Reply card
All the benefits of Kollicoat® IR Country BASF
in comparison with HPMC also Aktiengesellschaft
apply to Kollicoat® IR White:
Telephone G-MEP/ME – Li 554
■ High solids concentration can Attn: Dr. Hubertus Folttmann
be sprayed, which shortens Fax Carl-Bosch-Straße 64
production time D-67117 Limburgerhof
■ High flexibility of the films e-Mail Germany
■ Easily printable films
■ Easy-to-clean equipment
with either cold or warm
water
■ Engraved tablets can be
coated with excellent
results
Fax Reply
Local contact:
or Headquarters Germany:
+49-621-60-2 86 40
Please complete, copy and fax to us,
or detach the postcard and send it to us.
Please send the ■ Technical information
following information: on Kollicoat® Protect.
■ Technical information on ■ Technical information
Kollicoat® IR White. on Kollicoat® IR.
■ Sample of ■ Technical information on
Kollicoat® IR White 0.5 kg. Kollicoat® MAE grades.
■ Please contact me, I would ■ Newsletter “ExAct”
like to know more about (Excipients & Actives for Pharma).
Kollicoat® IR White.

The processing of Kollicoat® IR
White is an easy two-step
procedure:
1. Weighing of the necessary
amount of coating system
and water
2. Stirring of the coating
suspension for 10 to 15
minutes with a low-shear
mixer
The major advantages of the
product are:
■ Very quickly dispersible in
water
■ Due to the special method of
production used, films are very
homogeneous and smooth
■ As the pigments are embedded
in the polymer, no segregation
can occur
■ The system is miscible with
colorants such as iron oxides
or lakes to give colored
coatings
Please write Please
Title/Name
apply
in block letters.
postage
Thank you. Department stamp.
The Summary 11
Company
Address
Town Reply card
All the benefits of Kollicoat® IR Country BASF
in comparison with HPMC also Aktiengesellschaft
apply to Kollicoat® IR White:
Telephone G-MEP/ME – Li 554
■ High solids concentration can Attn: Dr. Hubertus Folttmann
be sprayed, which shortens Fax Carl-Bosch-Straße 64
production time D-67117 Limburgerhof
■ High flexibility of the films e-Mail Germany
■ Easily printable films
■ Easy-to-clean equipment
with either cold or warm
water
■ Engraved tablets can be
coated with excellent
results
Fax Reply
Local contact:
or Headquarters Germany:
+49-621-60-2 86 40
Please complete, copy and fax to us,
or detach the postcard and send it to us.
Please send the ■ Technical information
following information: on Kollicoat® Protect.
■ Technical information on ■ Technical information
Kollicoat® IR White. on Kollicoat® IR.
■ Sample of ■ Technical information on
Kollicoat® IR White 0.5 kg. Kollicoat® MAE grades.
■ Please contact me, I would ■ Newsletter “ExAct”
like to know more about (Excipients & Actives for Pharma).
Kollicoat® IR White.
Please send the ■ Technical information ■ Excipients ■ Actives
following information: on Kollicoat® Protect. Kollidon® grades Cremophor ® Analgesics
Group of povidone grades and Anesthetics
■ Technical information on ■ Technical information and copovidone Solutol® HS 15 Anti-Malarial Agents
Kollicoat® IR White. on Kollicoat® IR. products suitable Range of different Anti-Viral Agents
mainly as tablet ethoxylated Appetite Suppressant
■ Sample of ■ Technical information on binders, emulsifiers and Central Nervous System
Kollicoat® IR White 0.5 kg. Kollicoat® MAE grades. crospovidone as solubilizers Choloretic Agents
tablet disintegrant suitable for topical, Dermatica
■ Please contact me, I would ■ Newsletter “ExAct” and dissolution oral and parenteral Desinfectant
like to know more about (Excipients & Actives for Pharma). enhancer. formulations. Gastrointestinal System
Kollicoat® IR White. Kollidon® SR Soluphor ® P Respiratory System
Matrix sustained 2-pyrrolidone. Stimulants
release polymer. Lutrol® grades Sympathicomimetica
Ludipress® grades Range of PEGs Urinary System
Direct tabletting (Lutrol® E range) Vaso-Constrictors
aids for faster and poloxamers Intermediate
product develop- (Lutrol® F range)
ment and speedier for a wide variety Vitamins
processing. of pharmaceutical
Kollicoat ® grades dosage forms. ■ Custom
Range of aqueous Synthesis
based film formers,
We look forward to answering any questions you may have. Please cost efficient and ■ Value Added
fill in the postcard, detach it and return it to the address overleaf. ecological.

Pharma Solutions by BASF

BASF offers more than BASF Aktiengesellschaft

cGMP quality and supply Fine Chemicals Division
safety: technical expertise. Pharma Solutions
Our technical service is 67056 Ludwigshafen
always at your side. Germany

BASF wishes to create ■ Fax +49-621-60-2 86 40

a prosperous and sustain- ■ pharma.solutions@basf.com
Please contact your local BASF company or able future with you as our ■ www.pharma-solutions.basf.com
one of the following regional centers: customer – and partner.

Asia Europe North America South America

BASF Asia Pacific BASF Aktiengesellschaft BASF Corporation BASF S.A.
Regional HQ MEE/HP – J 550 Pharma Solutions Human Fine Chemicals BASF – the world’s leading chemical company – can look
Pharma Solutions Mr. Peter Hoffmann Mr. Javier Beeck Ms. Vanessa Occhipinti back on well over 140 years of success and has attained an
Dr. Danilo Mercado D-67056 Ludwigshafen 100 Campus Drive Estrada Samuel outstanding position as a reliable partner.
BASF East Asia Regional Germany Florham Park, NJ 07932 Aizemberg, 1707
Headquarters Ltd. Phone: +49-621-60-7 69 28 USA 09851-550 São Bernardo Our portfolio for the pharmaceutical industry comprises
45th Floor, Jardine House, Fax: +49-621-60-7 69 40 Phone: +1-973-245-6381 do Campo – SP a comprehensive range of major active ingredients and
No.1 Connaught Place, peter.wolfgang.hoffmann@ Fax: +1-973-245-6763 Brazil excipient brands as well as exclusive synthesis services.
Central, Hong Kong basf.com javier.beeck@ Phone: +55-11-4343-3341
Phone: +852-27311-588 basf.com Fax: +55-11-4343-2255
Fax.: +852-27349-638 vanessa.occhipinti@
mercadd@ basf.com
basf-east-asia.com.hk

MEMP 040902e-00
www.pharma-solutions.basf.com
Please send the ■ Technical information ■ Excipients ■ Actives
following information: on Kollicoat® Protect. Kollidon® grades Cremophor ® Analgesics
Group of povidone grades and Anesthetics
■ Technical information on ■ Technical information and copovidone Solutol® HS 15 Anti-Malarial Agents
Kollicoat® IR White. on Kollicoat® IR. products suitable Range of different Anti-Viral Agents
mainly as tablet ethoxylated Appetite Suppressant
■ Sample of ■ Technical information on binders, emulsifiers and Central Nervous System
Kollicoat® IR White 0.5 kg. Kollicoat® MAE grades. crospovidone as solubilizers Choloretic Agents
tablet disintegrant suitable for topical, Dermatica
■ Please contact me, I would ■ Newsletter “ExAct” and dissolution oral and parenteral Desinfectant
like to know more about (Excipients & Actives for Pharma). enhancer. formulations. Gastrointestinal System
Kollicoat® IR White. Kollidon® SR Soluphor ® P Respiratory System
Matrix sustained 2-pyrrolidone. Stimulants
release polymer. Lutrol® grades Sympathicomimetica
Ludipress® grades Range of PEGs Urinary System
Direct tabletting (Lutrol® E range) Vaso-Constrictors
aids for faster and poloxamers Intermediate
product develop- (Lutrol® F range)
ment and speedier for a wide variety Vitamins
processing. of pharmaceutical
Kollicoat ® grades dosage forms. ■ Custom
Range of aqueous Synthesis
based film formers,
We look forward to answering any questions you may have. Please cost efficient and ■ Value Added
fill in the postcard, detach it and return it to the address overleaf. ecological.

Pharma Solutions by BASF

BASF offers more than BASF Aktiengesellschaft

cGMP quality and supply Fine Chemicals Division
safety: technical expertise. Pharma Solutions
Our technical service is 67056 Ludwigshafen
always at your side. Germany

BASF wishes to create ■ Fax +49-621-60-2 86 40

a prosperous and sustain- ■ pharma.solutions@basf.com
Please contact your local BASF company or able future with you as our ■ www.pharma-solutions.basf.com
one of the following regional centers: customer – and partner.

Asia Europe North America South America

BASF Asia Pacific BASF Aktiengesellschaft BASF Corporation BASF S.A.
Regional HQ MEE/HP – J 550 Pharma Solutions Human Fine Chemicals BASF – the world’s leading chemical company – can look
Pharma Solutions Mr. Peter Hoffmann Mr. Javier Beeck Ms. Vanessa Occhipinti back on well over 140 years of success and has attained an
Dr. Danilo Mercado D-67056 Ludwigshafen 100 Campus Drive Estrada Samuel outstanding position as a reliable partner.
BASF East Asia Regional Germany Florham Park, NJ 07932 Aizemberg, 1707
Headquarters Ltd. Phone: +49-621-60-7 69 28 USA 09851-550 São Bernardo Our portfolio for the pharmaceutical industry comprises
45th Floor, Jardine House, Fax: +49-621-60-7 69 40 Phone: +1-973-245-6381 do Campo – SP a comprehensive range of major active ingredients and
No.1 Connaught Place, peter.wolfgang.hoffmann@ Fax: +1-973-245-6763 Brazil excipient brands as well as exclusive synthesis services.
Central, Hong Kong basf.com javier.beeck@ Phone: +55-11-4343-3341
Phone: +852-27311-588 basf.com Fax: +55-11-4343-2255
Fax.: +852-27349-638 vanessa.occhipinti@
mercadd@ basf.com
basf-east-asia.com.hk

MEMP 040902e-00
www.pharma-solutions.basf.com