GLOBALLY HARMONISED STARCH EXCIPIENTS FOR SOLID ORAL DOSAGE FORMULATIONS
UNI-PURE
F
/
UNI-PURE
FL
Speciality Starches
®
®
Premium pharmaceutical excipients for use in drug delivery
Ingredion offers two reliable pharmaceutical-grade corn/maize starch products – UNI-PURE® F and UNI-PURE® FL – that
pharmaceutical manufacturers have confidently formulated into their solid oral dosages for years and meet global standards.
UNI-PURE® F is an extra-white, free-flowing corn/maize starch for use in pharmaceutical products that meets requirements
of USP-NF, Ph. Eur, and JP monographs. When cooked in an aqueous system, it develops viscosity and sets to a firm gel upon
cooling. UNI-PURE® FL is corn/maize starch NF that has been carefully dried under controlled conditions to meet a moisture
specification that is lower than that found in conventional starches. This also meets USP-NF, Ph. Eur, and JP monographs. These
starches can be used as filler/diluents for both capsule and tablet dosage forms. Additionally, the starches can also be used as
disintegrants in tablet systems.
UNI-PURE® F is used as a binder, filler and disintegrant in a wide variety of pharmaceutical applications. The superior colour of
UNI-PURE® F is particularly desirable for the manufacture of tablets and capsules. This product is recommended whenever a
starch with a high degree of whiteness and free-flowing properties is desired.
UNI-PURE® FL is a corn starch with an unusually low moisture content that is desirable for use with moisture sensitive
ingredients and as a filler in capsule dosage forms. It will also inhibit caking of hygroscopic materials. When a product containing
UNI-PURE® FL is added to water and cooked, it will have a slightly higher viscosity than regular corn starch. It will have a smooth,
short texture when hot and set to a firm gel upon cooling.
PRODUCT PROFILE
DISINTEGRATION PROFILE
WET GRANULATION BINDER
UNI-PURE® F can be used as a disintegrant in pharmaceutical
applications. A 2-10% usage level is recommended for its
disintegrant effect in tablet formulations. The disintegrant profile
at 2% level as a function of tablet compression force is shown in
the figure below.
When UNI-PURE® F is used as a wet granulation binder, the
optimum concentration depends on the level of solvent, shear
conditions of the granulator, and the temperature of the
granulation. Furthermore, the binding properties of
UNI-PURE® F are retained after conventional, fluid-bed, and
high-shear granulations.
IMPROVES COMPRESSIBILITY
Hydrochlorothiazide (25mg) tablets
10
Hydrochlorothiazide (25mg) tablets
300
200
100
0
8
1000
1800
2600
3400
4200
Compression force (lbs)
5000
6
100
4
2
0
1000
2000 3000 4000 5000
Compression force (lbs)
6000
BINDER SELECTION PROCESS
The optimum performance of UNI-PURE® F depends on
various factors including the physicochemical properties of
the drug, type of filler and the process used to make granules
and tablet. In a given formulation, tablet performance is
determined by the processing conditions.
Process
(UNI-PURE F)
Wet Granulation
Binder Addition
Solution/Paste
2-5%
% Hydrochlorothiazide release
Crushing Strength (kP)
12
400
Disintegration time (seconds)
UNI-PURE F provides excellent binding properties in wet
granulation applications. UNI-PURE® F, when cooked in an
aqueous system, develops viscosity and sets to a firm gel upon
cooling and provides strong binding or adhesive properties.
®
80
60
40
1000 lbs compression force
3000 lbs compression force
5000 lbs compression force
20
0
0
10
20
30
40
Time (min)
50
60
FILLER/DILUENT
UNI-PURE® FL is recommended for use in tableting and
pharmaceutical dry mix applications where its low moisture
protects moisture sensitive ingredients while reducing any
tendency for caking. UNI-PURE® FL will absorb moisture
from the atmosphere and hence, it should be added to the
formulation just prior to tablet compression or capsule filling
for maximum performance.
PRODUCT SPECIFICATIONS
STORAGE AND HANDLING
PHYSICAL AND CHEMICAL CHARACTERSTICS
COLOURWhitish
FORMFine powder
MOISTURE (PACKED)
UNI-PURE F
14% maximum
UNI-PURE FL
4% maximum
GRANULATION
THRU USSS # 100
95%
THRU USSS # 200
85%
FOREIGN MATTER
Passes test*
IDENTIFICATIONPasses test
SULFATED ASH
0.5% maximum
PH 4.5 - 7.0
OXIDISING SUBSTANCES Passes test
SULFUR DIOXIDE
0.001% maximum
ORGANIC VOLATILE IMPURITIES Complies to standards
UNI-PURE® FL is packaged in drums with poly liners
inside with a net weight of 200 lbs. It is recommended
that UNI-PURE® FL be stored in a clean, dry area at
ambient temperature and away from aromatic material.
The retest date for UNI-PURE® FL is 24 months from the
date of manufacture.
* Ph. Eur requirement
MICROBIOLOGICAL SPECIFICATIONS
E. ColiNegative
SalmonellaNegative
KlebsiellaNegative
S. AureusNegative
P. AeurginosaNegative
LABEL DECLARATION
UNI-PURE® F and FL - Maize Starch Ph.Eur. / Corn Starch NF /
Corn Starch JP
CHEMICAL DESCRIPTION
CAS Registry Number: CAS Registry Name: 9005-25-8
Starch
TO FIND OUT MORE CONTACT US
Ingredion Germany GmbH | +49 40 239 150
Ingredion UK Ltd | +44 (0) 161 435 3308
ingredion.com/emea
Ingredion Germany GmbH
Gruener Deich 110,
20097 Hamburg
Germany
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