PARTIALLY PREGELATINISED

MAIZE STARCHES
FOR ORAL SOLID DOSAGE FORMS

LYCATAB® C
Partially pregelatinised maize starch

LYCATAB® C - LM
Low Moisture
partially pregelatinised maize starch

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 LYCATAB C
Partially pregelatinised maize starches
®

. . . . . . . . . . . . . . . . . . . . . .
for oral solid dosage forms
LYCATAB C-LM ®

C O N T E N T S

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2

Description, monographs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 4

Powder properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 6

Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 9
• Capsule filling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 10
• Direct Compression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 15
• Wet Granulation.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 17

Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 19

Literature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 21

P A G E 1
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 I n t r o d u c t i o n

. . . . . . . . . . . . . .
Native starch is a common excipient for tablet and
capsule manufacture. Due to its limited flow properties,
native starch often requires the use of additional
excipients and production steps, such as granulation.
Pregelatinised starches, obtained by a simple physical
modification of starch, are also well established
excipients.

LYCATAB® C, pregelatinised maize starch,

is designed for pharmaceutical use in oral solid dosage
forms.* LYCATAB® C-LM is our low moisture grade.

LYCATAB® C has all the properties of a versatile

excipient. It has been developed as filler for two-piece
hard gelatin capsules, but also as diluent binder for
direct compression and binder for wet granulation.

LYCATAB® C is a free-flowing and self-disintegrating

powder, suitable for many applications.
Excellent flow properties and an adapted bulk density

Introduction
allow homogenous filling of capsules.
It also contains native starch which ensures a rapid
disintegration and drug release.

LYCATAB® C-LM is designed as a specific capsule

filler for moisture sensitive APIs, improving the
stability of the formulation.
Once again, like LYCATAB® C it demonstrates well
adapted properties for capsule filling.

* ROQUETTE patents (EP 964 000 / US 6184213)

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 I n t r o d u c t i o n

. . . . . . . . . . . . . .
Native starch is a common excipient for tablet and
capsule manufacture. Due to its limited flow properties,
native starch often requires the use of additional
excipients and production steps, such as granulation.
Pregelatinised starches, obtained by a simple physical
modification of starch, are also well established
excipients.

LYCATAB® C, pregelatinised maize starch,

is designed for pharmaceutical use in oral solid dosage
forms.* LYCATAB® C-LM is our low moisture grade.

LYCATAB® C has all the properties of a versatile

excipient. It has been developed as filler for two-piece
hard gelatin capsules, but also as diluent binder for
direct compression and binder for wet granulation.

LYCATAB® C is a free-flowing and self-disintegrating

powder, suitable for many applications.
Excellent flow properties and an adapted bulk density

Introduction
allow homogenous filling of capsules.
It also contains native starch which ensures a rapid
disintegration and drug release.

LYCATAB® C-LM is designed as a specific capsule

filler for moisture sensitive APIs, improving the
stability of the formulation.
Once again, like LYCATAB® C it demonstrates well
adapted properties for capsule filling.

* ROQUETTE patents (EP 964 000 / US 6184213)

P A G E 2 P A G E 3
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 D e s c r i p t i o n , m o n o g r a p h s

. . . . . . . . . . . . . .
LYCATAB® C and LYCATAB® C-LM are obtained
by a physical modification of native maize starch
through a unique production process.
LYCATAB® C-LM is additionally dried.

LYCATAB® C and LYCATAB® C-LM consist

of both native and pregelatinised starch. They form
a stable and non-friable matrix. This specific
combination allows for rapid disintegration and
therefore fast drug release from oral pharmaceutical
preparations.
Figure 1: SEM of Lycatab® C,
magnification approx. x 50
LYCATAB® C and LYCATAB® C-LM meet all
the requirements of the EP monograph
“Starch, Pregelatinised”, the USP NF monograph
“Pregelatinized Starch” and the IP monograph
“Pregelatinised Starch”.

LYCATAB® C and LYCATAB® C-LM are natural

excipients of vegetable origin. They are compatible

Description, monographs
with most active substances.

Figure 2: SEM of Lycatab® C-LM,

magnification approx. x 200

P A G E 4 P A G E 5
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 D e s c r i p t i o n , m o n o g r a p h s

. . . . . . . . . . . . . .
LYCATAB® C and LYCATAB® C-LM are obtained
by a physical modification of native maize starch
through a unique production process.
LYCATAB® C-LM is additionally dried.

LYCATAB® C and LYCATAB® C-LM consist

of both native and pregelatinised starch. They form
a stable and non-friable matrix. This specific
combination allows for rapid disintegration and
therefore fast drug release from oral pharmaceutical
preparations.
Figure 1: SEM of Lycatab® C,
magnification approx. x 50
LYCATAB® C and LYCATAB® C-LM meet all
the requirements of the EP monograph
“Starch, Pregelatinised”, the USP NF monograph
“Pregelatinized Starch” and the IP monograph
“Pregelatinised Starch”.

LYCATAB® C and LYCATAB® C-LM are natural

excipients of vegetable origin. They are compatible

Description, monographs
with most active substances.

Figure 2: SEM of Lycatab® C-LM,

magnification approx. x 200

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 P o w d e r p r o p e r t i e s

. . . . . . . . . . . . . .
Particle Size/Flowability/Density
LYCATAB® C and LYCATAB® C-LM have a mean
particle size of about 100µm, as is typically required
in pharmaceutical production. Typical particle size
distributions are shown in Figure 3.
Both products are dust free (see table 1), resulting in
a good powder flow. Dust is also a source of problems
in pharmaceutical development and production.
The density and powder flow of these pregelatinised
starches are well adapted to its use as pharmaceutical
excipient.

Figure 3: Typical particle size distribution of LYCATAB® C and LYCATAB® C-LM

6
LYCATAB® C
5
LYCATAB® C-LM
4

Volume (%)
3

Powder properties 2

0
0.4 1 2 4 6 10 20 40 60 100 200 400 1000 2000

Particle diameter (µm)

LYCATAB® C and LYCATAB® C-LM

are white to off-white odourless powders
Table 1: Typical particle size distribution of LYCATAB® C and LYCATAB® C-LM
with enhanced flow properties.
LYCATAB® C and LYCATAB® C-LM LYCATAB® C LYCATAB® C-LM Native maize starch
are dispersible and partially soluble Dust Content (<30μm) ≤ 10% ≤ 10% 80%
in cold water.

Table 2: powder properties of LYCATAB® C and LYCATAB® C-LM

LYCATAB® C LYCATAB® C-LM

Bulk density 0.63 0.62
Tapped density 0.81 0.76
Flowability Free flowing Free flowing

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 P o w d e r p r o p e r t i e s

. . . . . . . . . . . . . .
Particle Size/Flowability/Density
LYCATAB® C and LYCATAB® C-LM have a mean
particle size of about 100µm, as is typically required
in pharmaceutical production. Typical particle size
distributions are shown in Figure 3.
Both products are dust free (see table 1), resulting in
a good powder flow. Dust is also a source of problems
in pharmaceutical development and production.
The density and powder flow of these pregelatinised
starches are well adapted to its use as pharmaceutical
excipient.

Figure 3: Typical particle size distribution of LYCATAB® C and LYCATAB® C-LM

6
LYCATAB® C
5
LYCATAB® C-LM
4

Volume (%)
3

Powder properties 2

0
0.4 1 2 4 6 10 20 40 60 100 200 400 1000 2000

Particle diameter (µm)

LYCATAB® C and LYCATAB® C-LM

are white to off-white odourless powders
Table 1: Typical particle size distribution of LYCATAB® C and LYCATAB® C-LM
with enhanced flow properties.
LYCATAB® C and LYCATAB® C-LM LYCATAB® C LYCATAB® C-LM Native maize starch
are dispersible and partially soluble Dust Content (<30μm) ≤ 10% ≤ 10% 80%
in cold water.

Table 2: powder properties of LYCATAB® C and LYCATAB® C-LM

LYCATAB® C LYCATAB® C-LM

Bulk density 0.63 0.62
Tapped density 0.81 0.76
Flowability Free flowing Free flowing

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 P o w d e r p r o p e r t i e s P o w d e r p r o p e r t i e s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Water content and sorption/
desorption Isotherms
Pregelatinised starches are moderately hygroscopic The low water content in LYCATAB® C-LM helps
substances, exhibiting the typical sigmoidal sorption preserve the chemical stability of moisture sensitive
isotherms of starch. API’s. Free water, potentially affecting the stability
The water content of LYCATAB® C is in equilibrium of formulations, might be bound by the low moisture
with the air humidity under moderate climatic grade of starch.
conditions. LYCATAB® C-LM is additionally dried
and therefore more hygroscopic. Specific storage Table 3: powder properties of LYCATAB® C and LYCATAB® C-LM
conditions such as keeping it in the original and
unopened packaging are requested in order to LYCATAB® C LYCATAB® C-LM
guarantee this low water content. Water content 14% max 7% max
Water activity (typical values) 0.25 0.08
Figure 4: Sorption and desorption isotherms
of LYCATAB® C and LYCATAB® C-LM
20
18
Water content at equilibrium (%)

16
14
12
10
8 LYCATAB® C Sorption
6 LYCATAB® C Desorption
4 LYCATAB® C-LM Sorption
2 LYCATAB® C-LM Desorption
0
0 20 40 60 80 100
Relative humidity (%)

P A G E 8 P A G E 9
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 P o w d e r p r o p e r t i e s P o w d e r p r o p e r t i e s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Water content and sorption/
desorption Isotherms
Pregelatinised starches are moderately hygroscopic The low water content in LYCATAB® C-LM helps
substances, exhibiting the typical sigmoidal sorption preserve the chemical stability of moisture sensitive
isotherms of starch. API’s. Free water, potentially affecting the stability
The water content of LYCATAB® C is in equilibrium of formulations, might be bound by the low moisture
with the air humidity under moderate climatic grade of starch.
conditions. LYCATAB® C-LM is additionally dried
and therefore more hygroscopic. Specific storage Table 3: powder properties of LYCATAB® C and LYCATAB® C-LM
conditions such as keeping it in the original and
unopened packaging are requested in order to LYCATAB® C LYCATAB® C-LM
guarantee this low water content. Water content 14% max 7% max
Water activity (typical values) 0.25 0.08
Figure 4: Sorption and desorption isotherms
of LYCATAB® C and LYCATAB® C-LM
20
18
Water content at equilibrium (%)

16
14
12
10
8 LYCATAB® C Sorption
6 LYCATAB® C Desorption
4 LYCATAB® C-LM Sorption
2 LYCATAB® C-LM Desorption
0
0 20 40 60 80 100
Relative humidity (%)

P A G E 8 P A G E 9
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 A p p l i c a t i o n s

. . . . . . . . . . . . . .
Capsule filling
LYCATAB® C and LYCATAB® C-LM have been
developed as cost-effective fillers and disintegration
aids for hard gelatin capsules.
Their physicochemical properties are therefore well
suited to the requirements of ideal capsule fillers.
Their powder physical properties are designed to obtain
best results in industrial process using all types of
equipment.

Adapted Density and Particle Size

Appropriate density is a necessary characteristic for
good filler for solid dosage forms.
The LYCATAB® C and LYCATAB® C-LM
production process results in an adequate density for
this application.

Applications
Compared to native maize starch, LYCATAB® C
and LYCATAB® C-LM have a lower bulk volume,
allowing a more effective filling of capsules.
Therefore the capsule size could even be reduced.
The particle size distribution of LYCATAB® C and
LYCATAB® C-LM aids mixing with the drug and easy
“plug-forming” of the powder mixture.
LYCATAB® C and LYCATAB® C-LM are multifunctional
The low dust content of LYCATAB® C
excipients, suited to the majority of solid oral preparations.
and LYCATAB® C-LM reduces powder losses and
Due to their specific properties, these pregelatinised starches
“fall-out” when transferring the plug.
contribute to a simple production process and assure a rapid
disintegration of the final formulation.
Both could be used as a flow aid for powder blends, Volume consistency
compounded for direct compression of tablets and as
A particular advantage of LYCATAB® C
a binder for wet granulation. They are excellent and fully
and LYCATAB® C-LM is that they exhibit low
integrated excipients for hard gelatin capsules, adapted
volume reduction under tamping, resulting in a
for a large range of drug substance concentrations.
consistent processing performance.

P A G E 10 P A G E 11
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 A p p l i c a t i o n s

. . . . . . . . . . . . . .
Capsule filling
LYCATAB® C and LYCATAB® C-LM have been
developed as cost-effective fillers and disintegration
aids for hard gelatin capsules.
Their physicochemical properties are therefore well
suited to the requirements of ideal capsule fillers.
Their powder physical properties are designed to obtain
best results in industrial process using all types of
equipment.

Adapted Density and Particle Size

Appropriate density is a necessary characteristic for
good filler for solid dosage forms.
The LYCATAB® C and LYCATAB® C-LM
production process results in an adequate density for
this application.

Applications
Compared to native maize starch, LYCATAB® C
and LYCATAB® C-LM have a lower bulk volume,
allowing a more effective filling of capsules.
Therefore the capsule size could even be reduced.
The particle size distribution of LYCATAB® C and
LYCATAB® C-LM aids mixing with the drug and easy
“plug-forming” of the powder mixture.
LYCATAB® C and LYCATAB® C-LM are multifunctional
The low dust content of LYCATAB® C
excipients, suited to the majority of solid oral preparations.
and LYCATAB® C-LM reduces powder losses and
Due to their specific properties, these pregelatinised starches
“fall-out” when transferring the plug.
contribute to a simple production process and assure a rapid
disintegration of the final formulation.
Both could be used as a flow aid for powder blends, Volume consistency
compounded for direct compression of tablets and as
A particular advantage of LYCATAB® C
a binder for wet granulation. They are excellent and fully
and LYCATAB® C-LM is that they exhibit low
integrated excipients for hard gelatin capsules, adapted
volume reduction under tamping, resulting in a
for a large range of drug substance concentrations.
consistent processing performance.

P A G E 10 P A G E 11
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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Figure 5 : Powder compressibility, measured
with 100g samples in EP 2.9.34.-3 settling device
Good machinability
70 The powder properties of LYCATAB® C and
60
LYCATAB® C-LM are well adapted for easy machining.
Industrial and pilot scale trials have proven the main

Volume reduction (ml)

50
advantages of LYCATAB® C and LYCATAB® C-LM:
40
z Good plug forming
30 z Fill weight uniformity of the capsules
20 z Short disintegration time of filled capsules
LYCATAB® C Native maize starch
z Self-lubricating properties
10
LYCATAB® C-LM Fully pregelatinised starch
0 Trials were performed on two types of capsule
0 200 400 600 800 1000 1200 filling machines:
Taps z LYCATAB® C with a Bosch GKF 120 dosing disc
machine, filling empty # 1 capsules (analysis after
15 min, under stabilised conditions)
z LYCATAB® C-LM with a Bonapace IN CAP
High compatibility with gelatine
dosing disc machine, filling empty #2 capsules.
LYCATAB® C and LYCATAB® C-LM are fully
LYCATAB® C and LYCATAB® C-LM are fully
compatible with gelatin. Capsule formulation with
integrated excipients for capsule filling. The standard
LYCATAB® C and LYCATAB® C-LM helps
deviation of the weight of filled capsules is low and the
guarantee the quality and consistency of pharmaceutical
disintegration time is short.
capsules over their complete shelf live.
LYCATAB® C and LYCATAB® C-LM are self-lubricated
• Brittleness Resistance powders and could be used without any addition of
Storage tests of capsules filled with LYCATAB® C a lubricant under pilot and industrial scale conditions.
at different humidities have indicated no drying Nevertheless, the recommended lubrication level for pure
of the capsule shell; the origin of the brittleness of LYCATAB® C is 0.2% Magnesium stearate. Lubrication
capsules. The mechanical properties of filled capsules helps achieve a better powder consolidation and improves
were not reduced when stored at relative humidity weight uniformity. It does not impair the disintegration time
of 10% or more over two weeks. of filled capsules. Due to the improved powder density, the
disintegration potential of the starch particles is better used.
• No Interaction with Gelatin
LYCATAB® C and by extension LYCATAB® C-LM
Table 4: Results of placebo capsule filling trials
do not cause any chemical interaction or “cross-linking”
with gelatin. These chemical interactions are known LYCATAB® C
LYCATAB® C LYCATAB® C-LM
to occur in the presence of some excipients which have with 0.2% Mg stereate
a detrimental effect on the dissolution of capsules. Equipment Bosch GKF 120 Bosch GKF 120 Bonapace IN CAP
The storage of filled capsules at 40°C and 75% relative Capsule size #1 #1 #2
humidity over three months had no effect on the
Mean filling weight (mg) 319.5 340.8 251
dissolution of capsules, or impair drug release.
Standard deviation (%) 0.38 0.20 1.09
Disintegration time 5 min 00 s 3 min 40 s 3 min 32 s

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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Figure 5 : Powder compressibility, measured
with 100g samples in EP 2.9.34.-3 settling device
Good machinability
70 The powder properties of LYCATAB® C and
60
LYCATAB® C-LM are well adapted for easy machining.
Industrial and pilot scale trials have proven the main

Volume reduction (ml)

50
advantages of LYCATAB® C and LYCATAB® C-LM:
40
z Good plug forming
30 z Fill weight uniformity of the capsules
20 z Short disintegration time of filled capsules
LYCATAB® C Native maize starch
z Self-lubricating properties
10
LYCATAB® C-LM Fully pregelatinised starch
0 Trials were performed on two types of capsule
0 200 400 600 800 1000 1200 filling machines:
Taps z LYCATAB® C with a Bosch GKF 120 dosing disc
machine, filling empty # 1 capsules (analysis after
15 min, under stabilised conditions)
z LYCATAB® C-LM with a Bonapace IN CAP
High compatibility with gelatine
dosing disc machine, filling empty #2 capsules.
LYCATAB® C and LYCATAB® C-LM are fully
LYCATAB® C and LYCATAB® C-LM are fully
compatible with gelatin. Capsule formulation with
integrated excipients for capsule filling. The standard
LYCATAB® C and LYCATAB® C-LM helps
deviation of the weight of filled capsules is low and the
guarantee the quality and consistency of pharmaceutical
disintegration time is short.
capsules over their complete shelf live.
LYCATAB® C and LYCATAB® C-LM are self-lubricated
• Brittleness Resistance powders and could be used without any addition of
Storage tests of capsules filled with LYCATAB® C a lubricant under pilot and industrial scale conditions.
at different humidities have indicated no drying Nevertheless, the recommended lubrication level for pure
of the capsule shell; the origin of the brittleness of LYCATAB® C is 0.2% Magnesium stearate. Lubrication
capsules. The mechanical properties of filled capsules helps achieve a better powder consolidation and improves
were not reduced when stored at relative humidity weight uniformity. It does not impair the disintegration time
of 10% or more over two weeks. of filled capsules. Due to the improved powder density, the
disintegration potential of the starch particles is better used.
• No Interaction with Gelatin
LYCATAB® C and by extension LYCATAB® C-LM
Table 4: Results of placebo capsule filling trials
do not cause any chemical interaction or “cross-linking”
with gelatin. These chemical interactions are known LYCATAB® C
LYCATAB® C LYCATAB® C-LM
to occur in the presence of some excipients which have with 0.2% Mg stereate
a detrimental effect on the dissolution of capsules. Equipment Bosch GKF 120 Bosch GKF 120 Bonapace IN CAP
The storage of filled capsules at 40°C and 75% relative Capsule size #1 #1 #2
humidity over three months had no effect on the
Mean filling weight (mg) 319.5 340.8 251
dissolution of capsules, or impair drug release.
Standard deviation (%) 0.38 0.20 1.09
Disintegration time 5 min 00 s 3 min 40 s 3 min 32 s

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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Superior disintegration properties Figure 7 : Dissolution of Acetaminophen capsules
at different pH values
and faster drug release
100

Acetaminophen dissolution rate (%)

LYCATAB® C and LYCATAB® C-LM have unique 90
80
and optimised disintegrating properties, contributing 70
to a high quality of pharmaceutical capsules. 60
The nongelatinized starch granules of LYCATAB® C 50
40
and LYCATAB® C-LM start to swell immediately LYCATAB® C pH 1,3
30
XX pH 1,3
in contact with water, leading to a rapid disintegration 20
LYCATAB® C pH 5,8
of the preparation. 10 XX pH 5,8
0
Furthermore, the low level of the cold-water soluble 0 5 10 15 20 25 30
fraction (cold water solubility around 7% only) and
Time (min)
the resulting low viscosity of LYCATAB® C and
LYCATAB® C-LM contributes to a very fast
penetration of water into the capsules and hence Not all partially pregelatinised starches are equivalent
an accelerated disintegration. with regards to drug dissolution rate.
Dissolution studies of LYCATAB® C in comparison with Compared to competitors, LYCATAB® C exhibits
competitor’s XX (partially pregelatinised starch - PPS) a faster and higher dissolution rate for soluble drugs
were conducted, using # 0 gelatin capsules filled with (example propranolol) and sparingly soluble drugs
a blend of 75% of partially pregelatinised starch and (example acetaminophen) over a wide pH range.
25% drug substance. These higher dissolution rates obtained with
LYCATAB® C are due to faster disintegration
Two different drugs, having different solubilities, have
of the capsules.
been selected as models:
• Propranolol chlorhydrate: soluble in water
• Acetaminophen: sparingly soluble in water

Figure 6: Dissolution of Propranolol capsules

at different pH values

100
Propranolol dissolution rate (%)

80

60
LYCATAB® C pH 1,3
40 XX pH 1,3
LYCATAB® C pH 4,7
20 XX pH 4,7
LYCATAB® C pH 6,8
XX pH 6,8
0
0 10 20 30

Time (min)

P A G E 14 P A G E 15
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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Superior disintegration properties Figure 7 : Dissolution of Acetaminophen capsules
at different pH values
and faster drug release
100

Acetaminophen dissolution rate (%)

LYCATAB® C and LYCATAB® C-LM have unique 90
80
and optimised disintegrating properties, contributing 70
to a high quality of pharmaceutical capsules. 60
The nongelatinized starch granules of LYCATAB® C 50
40
and LYCATAB® C-LM start to swell immediately LYCATAB® C pH 1,3
30
XX pH 1,3
in contact with water, leading to a rapid disintegration 20
LYCATAB® C pH 5,8
of the preparation. 10 XX pH 5,8
0
Furthermore, the low level of the cold-water soluble 0 5 10 15 20 25 30
fraction (cold water solubility around 7% only) and
Time (min)
the resulting low viscosity of LYCATAB® C and
LYCATAB® C-LM contributes to a very fast
penetration of water into the capsules and hence Not all partially pregelatinised starches are equivalent
an accelerated disintegration. with regards to drug dissolution rate.
Dissolution studies of LYCATAB® C in comparison with Compared to competitors, LYCATAB® C exhibits
competitor’s XX (partially pregelatinised starch - PPS) a faster and higher dissolution rate for soluble drugs
were conducted, using # 0 gelatin capsules filled with (example propranolol) and sparingly soluble drugs
a blend of 75% of partially pregelatinised starch and (example acetaminophen) over a wide pH range.
25% drug substance. These higher dissolution rates obtained with
LYCATAB® C are due to faster disintegration
Two different drugs, having different solubilities, have
of the capsules.
been selected as models:
• Propranolol chlorhydrate: soluble in water
• Acetaminophen: sparingly soluble in water

Figure 6: Dissolution of Propranolol capsules

at different pH values

100
Propranolol dissolution rate (%)

80

60
LYCATAB® C pH 1,3
40 XX pH 1,3
LYCATAB® C pH 4,7
20 XX pH 4,7
LYCATAB® C pH 6,8
XX pH 6,8
0
0 10 20 30

Time (min)

P A G E 14 P A G E 15
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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Direct compression Figure 8 : Compression profile of LYCATAB®C
and tablet disintegration compared to competitor’s
partially pregelatinised starch xx

LYCATAB® C fulfils all critical functions required 100

from direct compression excipients.
80

Tablet hardness (N)

LYCATAB® C’s unique composition of native and
60
pregelatinised starch gives it dual functionality:
40
disintegrant and binder.
LYCATAB® C
20
LYCATAB C’s superior flow properties and its
®
XX from competitor
binding properties allow its use in tablet production 0
0 1 2 3 4 5 6 7 8 9 10 11 12
as second DC filler. It could also improve the Compression force (kN)
powder flow of the blends. Therefore it contributes
to the weight uniformity and stable API content at
industrial production speed. 360

Tablet disintegration time (s)

LYCATAB® C
LYCATAB C only needs a low level of lubricant
® 300
XX from competitor
in direct compression. It also contributes to a reduction 240
in ejection forces during tableting. 180
It should be noted that the compactability of 120
pregelatinised starch excipients (such as LYCATAB® C 60
when used as a sole DC binder) could be reduced by 0
high ratios of Magnesium stearate, by too long mixing 0 10 20 30 40 50 60 70 80 90
Tablet hardness (N)
time, or non appropriate production conditions.
A film layer of Mg- stearate could form on the powder
surface, limiting its binding properties.
A careful determination of production parameters and LYCATAB® C with an adapted compactability ensures
the appropriate choice of lubricant is recommended. high tablet hardness at low compression forces, and a
low friability. It is valuable second filler – binder in DC
A comparative study was performed on a rotary press formulations.
(30 punches, 7 mm diameter, target tablet weight
100,0 mg) using following formula: LYCATAB® C’s superior disintegration properties
allow simple formulations without the addition of
Component Amount/tablet another disintegrant.
Active pharmaceutical ingredient (API) 3.0%
Partially pregelatinised starch
(Lycatab® C or XX from competitor) 48.5%

Microcristalline Cellulose (DC grade) 48.0%

Sodium Stearyl Fumarate 0.5%

The trials demonstrate the value of LYCATAB® C in

tablet formulations.

P A G E 16 P A G E 17
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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Direct compression Figure 8 : Compression profile of LYCATAB®C
and tablet disintegration compared to competitor’s
partially pregelatinised starch xx

LYCATAB® C fulfils all critical functions required 100

from direct compression excipients.
80

Tablet hardness (N)

LYCATAB® C’s unique composition of native and
60
pregelatinised starch gives it dual functionality:
40
disintegrant and binder.
LYCATAB® C
20
LYCATAB C’s superior flow properties and its
®
XX from competitor
binding properties allow its use in tablet production 0
0 1 2 3 4 5 6 7 8 9 10 11 12
as second DC filler. It could also improve the Compression force (kN)
powder flow of the blends. Therefore it contributes
to the weight uniformity and stable API content at
industrial production speed. 360

Tablet disintegration time (s)

LYCATAB® C
LYCATAB C only needs a low level of lubricant
® 300
XX from competitor
in direct compression. It also contributes to a reduction 240
in ejection forces during tableting. 180
It should be noted that the compactability of 120
pregelatinised starch excipients (such as LYCATAB® C 60
when used as a sole DC binder) could be reduced by 0
high ratios of Magnesium stearate, by too long mixing 0 10 20 30 40 50 60 70 80 90
Tablet hardness (N)
time, or non appropriate production conditions.
A film layer of Mg- stearate could form on the powder
surface, limiting its binding properties.
A careful determination of production parameters and LYCATAB® C with an adapted compactability ensures
the appropriate choice of lubricant is recommended. high tablet hardness at low compression forces, and a
low friability. It is valuable second filler – binder in DC
A comparative study was performed on a rotary press formulations.
(30 punches, 7 mm diameter, target tablet weight
100,0 mg) using following formula: LYCATAB® C’s superior disintegration properties
allow simple formulations without the addition of
Component Amount/tablet another disintegrant.
Active pharmaceutical ingredient (API) 3.0%
Partially pregelatinised starch
(Lycatab® C or XX from competitor) 48.5%

Microcristalline Cellulose (DC grade) 48.0%

Sodium Stearyl Fumarate 0.5%

The trials demonstrate the value of LYCATAB® C in

tablet formulations.

P A G E 16 P A G E 17
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 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Wet granulation Any fluctuations in the cold water solubility and
gelatinization level of pregelatinised starches have
LYCATAB® C, like all other pregelatinised starches, a direct impact of the needed water quantities for
is partially soluble in cold water. It can therefore be granulation.
employed as a binder-disintegrant in wet granulation, The granulates obtained from trials 1, 2 and 3, were
improving hardness and disintegration of tablets. lubricated with 0.3% Mg- stearate and then compressed
The recommended application level is about 15% in on a single punch machine using concave 13mm punches.
the total formulation.
Figure 9 : Compression profiles of granulates obtained
A comparative study was performed with a DIOSNA with LYCATAB® C or with the partially pregelatinised starch xx
high shear granulator using following formula: and tablet disintegration times
220
a- monohydrate lactose 75% 200
Microcrystalline cellulose (DC grade) 10% 180
160

Tablet hardness (N)

Partially pregelatinised starch 140
(LYCATAB® C or competitor’s XX ) 15%
120
100
Water q.s.
80
Trial n°1
60
40 Trial n°2
Granulation Studies: 20 Trial n°3
0
Trial 1 Trial 2 Trial 3 0 10 20 30 40 50
Trial 1 competitor’s xx
Compression force (kN)
Competitor’s XX LYCATAB® C LYCATAB® C Trial 2 LYCATAB® C, identical
granulation conditions as with XX
25% water quantity
increase Trial 3 LYCATAB® C, more water 70
Same water quantity and granulation Same granulation
procedure were applied

Tablet disintegration time (s)

procedure as for 60
trials 1&2
50

40
To obtain granulates with a similar particle size,
more water is required when granulating with 30 Trial n°1
Trial n°2
LYCATAB® C in comparison to XX from competitor. 20
Trial n°3
As a result, the drying step for the granulate is
10
prolonged. 0 20 40 60 80 100 120 140 160 180 200 220
These differences are due to their different production Tablet hardness (N)
processes, resulting in different ratios of the cold water
soluble fraction and the percentage of pregelatinised
Tablets obtained from granulates with LYCATAB® C
starch. LYCATAB® C has a rather low, but very stable
and with competitor’s XX as binder & disintegrant have
content of soluble fractions. LYCATAB® C consists of
similar hardness and cohesion. However tablets made of
controlled ratios of native and pregelatinised starch,
LYCATAB® C disintegrate much faster (~40% faster),
resulting from a unique process.
demonstrating the excellent disintegration properties
of LYCATAB® C.

P A G E 18 P A G E 19
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13748BroLYCATABrange.indd 20-21 23/09/14 11:19

 A p p l i c a t i o n s A p p l i c a t i o n s

. . . . . . . . . . . . . .

. . . . . . . . . . . . . .
Wet granulation Any fluctuations in the cold water solubility and
gelatinization level of pregelatinised starches have
LYCATAB® C, like all other pregelatinised starches, a direct impact of the needed water quantities for
is partially soluble in cold water. It can therefore be granulation.
employed as a binder-disintegrant in wet granulation, The granulates obtained from trials 1, 2 and 3, were
improving hardness and disintegration of tablets. lubricated with 0.3% Mg- stearate and then compressed
The recommended application level is about 15% in on a single punch machine using concave 13mm punches.
the total formulation.
Figure 9 : Compression profiles of granulates obtained
A comparative study was performed with a DIOSNA with LYCATAB® C or with the partially pregelatinised starch xx
high shear granulator using following formula: and tablet disintegration times
220
a- monohydrate lactose 75% 200
Microcrystalline cellulose (DC grade) 10% 180
160

Tablet hardness (N)

Partially pregelatinised starch 140
(LYCATAB® C or competitor’s XX ) 15%
120
100
Water q.s.
80
Trial n°1
60
40 Trial n°2
Granulation Studies: 20 Trial n°3
0
Trial 1 Trial 2 Trial 3 0 10 20 30 40 50
Trial 1 competitor’s xx
Compression force (kN)
Competitor’s XX LYCATAB® C LYCATAB® C Trial 2 LYCATAB® C, identical
granulation conditions as with XX
25% water quantity
increase Trial 3 LYCATAB® C, more water 70
Same water quantity and granulation Same granulation
procedure were applied

Tablet disintegration time (s)

procedure as for 60
trials 1&2
50

40
To obtain granulates with a similar particle size,
more water is required when granulating with 30 Trial n°1
Trial n°2
LYCATAB® C in comparison to XX from competitor. 20
Trial n°3
As a result, the drying step for the granulate is
10
prolonged. 0 20 40 60 80 100 120 140 160 180 200 220
These differences are due to their different production Tablet hardness (N)
processes, resulting in different ratios of the cold water
soluble fraction and the percentage of pregelatinised
Tablets obtained from granulates with LYCATAB® C
starch. LYCATAB® C has a rather low, but very stable
and with competitor’s XX as binder & disintegrant have
content of soluble fractions. LYCATAB® C consists of
similar hardness and cohesion. However tablets made of
controlled ratios of native and pregelatinised starch,
LYCATAB® C disintegrate much faster (~40% faster),
resulting from a unique process.
demonstrating the excellent disintegration properties
of LYCATAB® C.

P A G E 18 P A G E 19
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 C o n c l u s i o n

. . . . . . . . . . . . . .
LYCATAB® C and LYCATAB® C-LM are partially
pregelatinised maize starches complying with major
pharmacopeial monographs.
LYCATAB® C and LYCATAB® C-LM consist of
both native and pregelatinised starch, and therefore act
as both a binder and as an effective disintegrant. Good
disintegration properties and low lubricant requirements
make LYCATAB® C the filler of choice for hard gelatin
capsules, especially when using moisture sensitive API
with the use of LYCATAB® C-LM.

LYCATAB® C is also a highly effective binder-

disintegrant in direct compression and wet granulation.

LYCATAB® C is a natural excipient with high

versatility in the formulation of pharmaceutical
products.

Conclusion

P A G E 20 P A G E 21
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 C o n c l u s i o n

. . . . . . . . . . . . . .
LYCATAB® C and LYCATAB® C-LM are partially
pregelatinised maize starches complying with major
pharmacopeial monographs.
LYCATAB® C and LYCATAB® C-LM consist of
both native and pregelatinised starch, and therefore act
as both a binder and as an effective disintegrant. Good
disintegration properties and low lubricant requirements
make LYCATAB® C the filler of choice for hard gelatin
capsules, especially when using moisture sensitive API
with the use of LYCATAB® C-LM.

LYCATAB® C is also a highly effective binder-

disintegrant in direct compression and wet granulation.

LYCATAB® C is a natural excipient with high

versatility in the formulation of pharmaceutical
products.

Conclusion

P A G E 20 P A G E 21
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 L i t e r a t u r e

. . . . . . . . . . . . . .
1.) Handbook of Pharm. Excipients, 7th edition, Pharm. Press, London
2.) Häusler, O, Lefevre, Ph., Use of partially pregelatinised corn starch as filler for two piece
hard gelatin capsules, Poster, 4th World meeting on Pharmaceutics and Biopharm., 2002,
http://www.roquette-pharma.com/media/deliacms/media/5/511- c7d0fe.pdf
3.) Deepak, G. et al. Formulation and evaluation of Irbesartan immediate Release Tablets,
International Research Journal of Pharmacy 2012, 3 (4), 410- 415
4.) Jahn, T., Steffens, K.-J. , Press chamber coating as external lubrication for high speed
rotary press…, Drug Dev. and Ind. Pharm. , 2005, 31, 951-957
5.) Fechner, P.M. et al., Influence of water on Molecular and Morphological Structure of
various Starches and Starch Derivatives, Starch, 2005, 57, 605-615

Literature

P A G E 22 P A G E 23
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 L i t e r a t u r e

. . . . . . . . . . . . . .
1.) Handbook of Pharm. Excipients, 7th edition, Pharm. Press, London
2.) Häusler, O, Lefevre, Ph., Use of partially pregelatinised corn starch as filler for two piece
hard gelatin capsules, Poster, 4th World meeting on Pharmaceutics and Biopharm., 2002,
http://www.roquette-pharma.com/media/deliacms/media/5/511- c7d0fe.pdf
3.) Deepak, G. et al. Formulation and evaluation of Irbesartan immediate Release Tablets,
International Research Journal of Pharmacy 2012, 3 (4), 410- 415
4.) Jahn, T., Steffens, K.-J. , Press chamber coating as external lubrication for high speed
rotary press…, Drug Dev. and Ind. Pharm. , 2005, 31, 951-957
5.) Fechner, P.M. et al., Influence of water on Molecular and Morphological Structure of
various Starches and Starch Derivatives, Starch, 2005, 57, 605-615

Literature

P A G E 22 P A G E 23
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 International technical support
Roquette, one of the leading manufacturers
offering starch derivatives and polyols, has
developed a wide range of products and services
especially dedicated to the pharmaceutical and
cosmetic industries.
Based on this experience, Roquette has been
extending its range of starch excipients through
technical innovation, while combining quality
with performance.
At Roquette, a team of pharmacists and
development scientists, supported by a dedicated
Application Development Center, are at your
disposal for further information and assistance
regarding the use of LYCATAB® or other
excipients from Roquette.

Roquette Frères
62080 Lestrem cedex France
Fax 33 (0)3 21 63 9464 - Telephone 33 (0)3 21 63 36 00
The information contained in this document is, to the best of our knowledge, true and accurate
but all instructions, recommendations or suggestions are made without guarantee. Since the conditions
of use are beyond our control, we disclaim any liability for loss and/or damage suffered from use
of these data or suggestions. Furthermore, no liability is accepted if use of any product in accordance
with these data or suggestions infringes any patent.
No part of this document may be reproduced by any process without our prior written permission.

® Registered trademark of ROQUETTE Frères - © Roquette Frères S.A./D3C - 09/2014

P A G E 24
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 R O Q UE T T E W ORL D W I D E

www.roquette.com
EURO PE TURKEY
Roquette Tarım ve Gıda
FRANCE San. ve Tic. Ltd. Sti.
Roquette Frères Büyükdere Cad. Harman Sok.
Corporate Headquarters Duran I·ş merkezi No:4 K:3
1 rue de la Haute Loge 34394 Levent I·stanbul - Turkey
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Telephone: + 49 69 60 91 050 Zhong Road, Shanghai 200031, China
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109147; Moscow - Russia #14-02/03 Central Plaza,
Telephone: +7 (495) 775-75-87 Singapore 168730 - Singapore
Fax: +7 (495) 775-75-88 Telephone: + 65 6416 3377

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