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

Solubilisationrequired

ElementaryOsmoticTablet

Function

Partially Pregelatinized Maize Starch STARCH 1500 ®

Starch 1500 Starch 1500 StarCap 1500

The shape and size of StarCap 1500 results in improved �ow over similarly sized MCC.Consistency of shape and particle size distribution means good �owability 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 SodiumDemonstrating 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

Hard

ness

(kp)

0

10

20

30

40

50

60

70

80

90

100

0 5 10 15 20 25 30 35 40 45 50

% D

issol

ution

Starch 1500® Formulation

Povidone/ Croscarmellose Formulation

StarCap 1500

Starch 1500® FormulationPovidone / Croscarmellose Formulation

Har

dnes

s (k

p)

% D

isso

lutio

n

Starch 1500® partially pregelatinized maize starch results in partial solubility, increased particle size, improved �ow properties and good compactibility compared to native starch.Functions as binder and disintegrant. Provides excellent stability for moisture sensitive drugs and cost e�ective 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 �owing, processed to provide good compactibility, especially for dry processes.

Wei

ght

(g)

Time (s)

Starch 1500® FormulationPovidone / 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)

Carr’s 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 Pacific 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 di�erences 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 39.9Starch 1500 81.1

39.981.1

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 Dicalcium PhosphateDihydrate

MicrocrystallineCellulose

Starch 1500® StarCap 1500®

Wat

er A

ctivi

ty

LOD

LOD

Wat

er A

ctivi

ty Vs

LOD

0

20

40

60

80

100

0 2 4 6 8 10 12

% H

CTZ

dis

solv

ed

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 anexcellent 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

Wat

er A

ctiv

ity

LOD

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 toMETHOCEL™ 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

Dru

g C

once

ntra

tion

(%)

Sample18

Dru

g C

once

ntra

tion

(%)

120

18Sample

Dru

g C

once

ntra

tion

(%)

Sample18

120

MCC

RSD = 4.26%RSD = 4.75% RSD = 3.00%UCL UCLUCL

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%

Asp

irin

rele

ased

Time (mins)