DiSPERZiSTADispersible Filler for Supplement Tablet

Application Data

Contents

Performance of placebo tablets

DiSPERZiSTA is compatible with "100 N tablet hardness" and "10 seconds oral disintegration time" in a 250mg φ 8mm tablet size.
It can achieve excellent disintegration even under high compression force.

Shape of tablet 250mg, φ 8mm, Flat shape
Compression Force ( kN ) 4 6 8 10
Tablet Hardness ( N ) 46 78 114 148
Disintegration Time ( s ) 18 16 21 28
Oral Disintegration Time ( in vivo ) ( s ) 13 12 14 19
Oral Disintegration Time ( in vivo ) ( s ) 6 8 12 18
Friability ( % ) 0.16 0.09 0.09 0.07
Compression Force CV ( % ) 1.3 1.6 1.6 1.7
Tablet Weight CV( % ) 0.25 0.21 0.19 0.20
graf
Components of ODT:
DPZ-501 ( 99.5% ) + Ca Stearate ( 0.5% )
Tablet Hardness:
Measured by electronic hardness tester ( Avg. n=10 )
Disintegration time:
Measured by JP general test method ( Avg. n=6 )
Oral disintegration time ( in vivo ) :
3 times at a time measured by 3 adults ( Avg. n=9 )
Oral disintegration time ( in vitro ) :
Measured by Tricorptester ( Avg. n=6 ) ( Okada Seiko Co., Ltd. Tokyo, Japan )

Friability:
Measured by JP general test method
Tablet Weight CV:
By random sampling ( Avg. n=10 )
Tableting Conditions:
Rotary-Press, 6 stations, 20 rpm, 250mg, φ 8mm, Flat shape, open feeder.

Contribution of unique granulation to compaction property

Applying a unique wet granulation method, DiSPERZiSTA improves compaction property compared to a simple mixture of individual ingredients.

graf graf
Components of ODT:
DPZ-501 ( 99.5% ) +Ca Stearate ( 0.5% )
Tablet Hardness:
Measured by electronic hardness tester ( Avg. n=6 )
Disintegration time:
Measured by JP general test method ( Avg. n=6 )
Tableting Conditions:
Hand-press tableting, 250mg, φ 8mm, Flat Shape

Application example - Formulation with typical Nutraceutical ingredients

Example
1

100mg/tablet
Vitamin C

500mg, φ 12mm
Flat shape

Components Ratio
DPZ-501 78.5%
Vitamin C 20.0%
Sucralose 1.0%
Calcium Stearate 0.5%

Compression force: 13kN
Tablet hardness: 73N
Disintegration time: 24sec.

Example
2

250mg/tablet
N-Acetylglucosamine

500mg, φ 12mm,
Radius edge

Components Ratio
DPZ-501 49.9%
N-Acetylglucosamine 49.9%
Sucrose fatty acid ester 0.2%

Compression force: 22kN
Tablet hardness: 151N
Disintegration time: 30sec.

Example
3

16μg/tablet
Vitamin D

250mg, φ 8mm
Flat shape

Components Ratio
DPZ-501 91.9%
Vitamin D Compound 5.1%
LPA Compound 0.5%
Orange Flavor 2.0%
Calcium Stearate 0.5%

Compression force: 6kN
Tablet hardness: 76N
Disintegration time: 22sec.

Tableting conditions:
Rotary-Press, Open feeder
Tablet Hardness:
Measured by electronic hardness tester ( Avg. n=10 )
Disintegration time:
Measured by JP general test method ( Avg. n=6 )
Oral disintegration time ( in vivo ) :
Each 2 times by 3 adults ( Avg. n=6 )

Compatibility with Lubricants

DiSPERZiSTA is hard to be effected by lubricants.

Lubricants Calcium stearate Sucrose fatty acid ester
Amount of Lubricant ( % ) 0.5 1.0 1.0 2.0 3.0
Tablet Hardness ( N ) 63 71 74 67 65
Disintegration time ( s ) 18 17 13 17 19
Orally disintegration time ( s ) 7 8 8 9 10
Components of ODT:
DPZ-501 ( 97.0-99.5% ) +each lubricant ( 0.5-3.0%)
Mixing method:
By hand shake, 30 times
Tablet Shape:
250mg, φ 8mm, Flat shape
Tableting Conditions:
Rotary-Press, 12 stations, open feeder
Tablet Hardness:
Measured by electronic hardness tester ( Avg. n=10 )
Disintegration time:
Measured by JP general test method ( Avg. n=6 )
Orally disintegration time ( in vitro ):
Measured by Tricorptester ( Avg. n=6 ) ( Okada Seiko Co., Ltd. Tokyo, Japan )

High content Nutraceutical ingredient per tablet

DiSPERZiSTA shows excellent formability and disintegration in ODT with high-content nutraceutical ingredients.

( 1 ) Vitamin C ( 250mg, φ 8mm )

Vitamin C ( % ) 0 40 50
Compression Force ( kN ) 6 12 14 12 14
Tablet Hardness ( N ) 75 49 56 38 41
Disintegration Time ( s ) 18 26 30 26 24

Disclaimer

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( 06/2017 )