Oral Solid Dose
SuperTab® 21AN
Controlled, efficient processing
SuperTab® and Lactopress® are DFE Pharma’s brand names for
direct compression lactose. SuperTab® 21AN is a highly consistent,
anhydrous lactose. The characteristic structure contains clusters of
microcrystals of predominantly anhydrous β-lactose. Due to being
an anhydrous lactose it has a low moisture content. This property
makes SuperTab® 21AN a popular choice in formulating with moisture
sensitive API’s. The unique, low levels of crystalline water makes the
use of SuperTab® 21AN with PAT technologies efficient.
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SuperTab® 21AN
Benefits
Allows excellent compaction and r­ e-compaction
Tablet crushing strength remains high after recompactability. Therefore
Part of a portfolio offering
­enhanced ­functionality
­SuperTab® 21AN is the preferred choice for dry granulation processes.
DFE Pharma offers more anhydrous grades with different particle sizes and morphology to enable a best
fit with your formulation ­requirements.
6
5
Flowdex (mm)
Tensile strength (MPa)
7
4
3
Dry Granulation Pressure (kN/cm)
4.2
2.1
6.3
SuperTab® 21AN
2
1
0
4
6
8
10
12
14
16
18
Flowability
30
20
Good flow
20
Excellent flow
10
Compaction Force (kN)
0
Suitable for moisture sensitive API
SuperTab® 21AN
Supertab® 22AN
Supertab® 24AN
The unique, low levels of crystalline water makes the use of SuperTab® 21AN with PAT
Amount of Beta-lactose (%w/w)
technologies e
­ fficient. Typically SuperTab® 21AN contains about 80% of the β-isomer
100
90
80
70
60
Tablet Tensile Strength (N)
Exceptional low crystalline water amount
Compressability
400
Dry Granulation pressure (kN/cm)
SuperTab® 21AN
SuperTab® 22AN
SuperTab® 24AN
300
200
100
50
40
30
0
20
8
10
10
0
12
14
16
Compaction force (kN)
1
5
10
Number of batches in 2018
Facts
Cumulative undersize %
Typical product data
Complies with Ph. Eur., USP-NF, JP
Kosher & Halal certified
Particle size distribution
Method: by Airjet sieve
100
SuperTab® 21AN
90
80
70
60
50
40
Sieve %w/w < 45 µm
≤ 20
Poured density
0.72 g/ml
Sieve %w/w < 150 µm
40 - 65
Tapped density
0.91 g/ml
Sieve %w/w < 250 µm
≥ 80
Karl Fischer (moisture)
< 0.5% w/w
30
20
10
0
1
10
100
1000
Particle size /µm
Packaging
Bag
Drum
Capacity
25 kg
50 kg
Shelf life
2 years
2 years
In pursuit of excipient excellence