0

50
100
150
0 10 20 30 40 50 60 70 80 90 100
StarCap 1500
MCC 90 micron
Starch 1500
MCC 50 micron
Typical Properties Flow Properties
Solubilisation
required
Elementary
Osmotic
Tablet

Function
Partially Pregelatinized Maize Starch
STARCH 1500

Starch 1500
Starch 1500 StarCap 1500
The shape and size of StarCap 1500 results in improved fow over similarly sized MCC.
Consistency of shape and particle size distribution means good fowability and less need for additional glidant.

Amylopectin ~ 73% water soluble polymer providing binding properties when released from starch grain (gelatinization)
Amylose ~ 27% insoluble polymer swells when wetted providing disintegrant properties in the ungelatinized starch grains
Corn Starch Starch 1500
StarCap 1500






Composition
x StarCap 1500
MCC 90 micron
Starch 1500
MCC 50 micron
Comparison of Starch 1500 to PVP and Croscarmellose Sodium
Demonstrating improvements in binding and disintegration properties, while reducing cost of excipient by 60% (guaifenesin study)
2
4
6
8
10
12
14
16
4 6 8 10 12 14 16 18 20 22 24 26
H
a
r
d
n
e
s
s
(
k
p
)


0
10
20
30
40
50
60
70
80
90
100
0 5 10 15 20 25 30 35 40 45 50
%
D
is
s
o
lu
t
o
n


Starch 1500 Formulaton
Povidone/ Croscarmellose Formulaton
StarCap 1500
Starch 1500 Formulation
Povidone / Croscarmellose Formulation
H
a
r
d
n
e
s
s

(
k
p
)
%

D
i
s
s
o
l
u
t
i
o
n
Starch 1500 partially pregelatinized maize starch results in partial solubility, increased particle size,
improved fow properties and good compactibility compared to native starch.
Functions as binder and disintegrant. Provides excellent stability for moisture sensitive drugs and cost efective content
uniformity as a carrier for low dose APIs.
StarCap 1500 co-processed starch excipient is a mix of globally accepted excipients (corn starch and
pregelatinized starch) designed for use in capsules and tablets.
Functions as a diluent with excellent disintegration and dissolution properties independent of media pH. Inert and free
fowing, processed to provide good compactibility, especially for dry processes.

W
e
i
g
h
t

(
g
)
Time (s)
Starch 1500 Formulation
Povidone / Croscarmellose Formulation
Compression Force (kN) Time (mins)
200
250
300
~20
~65
0.61
0.82
26
3.3
7.2
0.33
5-20%
(range 1-50%)
~2
~90
0.42
0.58
28
5.7
9.1
0.41
1-99%
Gelatinization Level (%)

Particle Size (micron)
Bulk Density (g/ cc)
Tapped Density (g/ cc)
Carrs Comp. Index (%)
Flow Rate (g/ sec)
Moisture (%)
Water Activity

Typical Use Levels

Technical Bulletin
For more information, contact your Colorcon representative or call:
North America Europe/Middle East/Africa Asia Pacifc Latin America
+1-215-699-7733 +44-(0)-1322-293000 +65-6438-0318 +54-11-5556-7700
You can also visit our website at www.colorcon.com
BPSI Holdings LLC, 2012. The information contained in this document is
proprietary to Colorcon and may not be used or disseminated inappropriatly.
All trademarks, except where noted, are property of BPSI Holdings LLC.
METHOCEL is the Trademark of the Dow Chemical Company.
FRS_Starch1500_V2_0712
Dose Uniformity
Starch 1500 as diluent in matrix formulations can minimize diferences in drug release (f 2 >50) despite variations in properties of hypromellose
(METHOCEL K100LV). Replacing lactose with Starch 1500 as diluent, results in more robust formulations. Recent studies have highlighted that
similar combinations can be used to reduce the variability that may be associated with hydrophilic matrices through Quality by Design (QbD).
Filler f
2
Lactose 39.9
Starch 1500 81.1
39.9
81.1
Starch 1500 Low Dose Uniformity
0.25
0.30
0.35
0.40
0.45
0.50
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
Lactose Anhydrous Lactose Monohydrate DicalciumPhosphate
Dihydrate
Microcrystalline
Cellulose
Starch 1500 StarCap 1500
W
a
te
r A
c
t
v
ity

L
O
D

LOD
W
a
t
e
r

A
c
t
i
v
i
t
y

V
s

L
O
D
0
20
40
60
80
100
0 2 4 6 8 10 12
%

H
C
T
Z

d
i
s
s
o
l
v
e
d

Time (hours)
Effect of particle size and diluent (30% polymer level)
Low %thru 230 mesh (Starch 1500)
High %thru 230 mesh (Starch 1500)
Low %thru 230 mesh (Lactose)
High %thru 230 mesh (Lactose)
High polymer level,
Low viscosity,
Medium %HP
Reference, CRS 2011 Poster : Deng H, Use of
Starch 1500 to minimize variability on drug
release from hydrophilic matrices.
Reduction in cost and complexity
Eliminates wet granulation step
Improves content uniformity
Moisture scavenging properties of Starch 1500 makes it an
excellent diluent to enhance stability of moisture sensitive drugs.
While Starch 1500 has a high moisture content, it has low water
activity, this gives better stability to moisture sensitive actives.
Moisture is bound compared to free, as in other excipients.
10.0

W
a
t
e
r

A
c
t
i
v
i
t
y
L
O
D
Lactose Lactose DCP MCC Starch StarCap
Improved Stability for Moisture Sensistive Actives Comparison of Water Activity vs Loss on Drying (LOD)
Reference: Hashim Ahmed, Ph.D. and Navnit Shah, Ph.D. Formulation of Low Dose Medicine-
Theory and Practice. Amer Pharm Review, Vol 3, Issue 3 (2000).
80
85
90
95
100
105
115
0 2 4 6 8 12 14 16
110
10
Lactose
Sample
80
85
90
95
100
105
110
115
0 2 4 6 8 10 12 14 16

80
85
90
100
105
110
115
0 2 4 6 8 10 12 14 16
95
Starch 1500
Colorcon has negotiated exclusive rights for customers using pregelatinized starch and hydrophilic polymers (including, but not limited to
METHOCEL premium cellulose ethers), covered under patent by Janssen (US Patent No 6,667,060).
Lactose as the Carrier

Starch 1500 as the Carrier
Monohydrate 1500 1500
LOD
Water Activity
120
D
r
u
g

C
o
n
c
e
n
t
r
a
t
i
o
n

(
%
)
Sample
18
D
r
u
g

C
o
n
c
e
n
t
r
a
t
i
o
n

(
%
)
120
18
Sample
D
r
u
g

C
o
n
c
e
n
t
r
a
t
i
o
n

(
%
)
Sample
18
120
MCC
RSD = 4.26% RSD = 4.75% RSD = 3.00%
UCL UCL UCL
Mean
LCL
Mean
LCL
Mean
LCL
MCC as the Carrier
10.0
0
20
40
60
80
100
0 10 20 30


MCC/CCS Initial MCC/CCS 3 month MCC/CCS 6 month
MCC/ST1500/CCS Initial MCC/ST1500/CCS 3 month MCC/ST1500/CCS 6 month
Impact of Starch 1500 on stability of aspirin
%

A
s
p
i
r
i
n

r
e
l
e
a
s
e
d
Time (mins)