GRANFILLER-DExcipient for Orally Disintegrating Tablet

Application Data

Contents

Performance of placebo tablets

GRANFILLER-D GNF-D211 / GNF-D215 are compatible with “100N tablet hardness” and “20 sec oral disintegration time” in 250mg φ8mm.
GRANFILLER-D can realize excellent disintegration even under high compression force.

Basic Performance ( 250mg, Φ8mm, Flat Beveled Edge )

GNF-D211 GNF-D215
Compression Force ( kN ) 4 6 8 4 6 8
Tablet Hardness ( N ) 50 80 110 52 83 108
Disintegration Time [Pharmacopoeia] ( s ) 12 15 21 11 15 18
Oral Disintegration Time [in vivo] ( s ) 13 14 22 11 11 14
Oral Disintegration [in vitro] ( s ) 12 16 25 9 12 18
Friability ( % ) 0.30 0.12 0.06 0.23 0.05 0.05
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Components of ODT :
GNF-D211/GNF-D215 ( 99.5% ) + Mg Stearate ( 0.5% )
Tablet Hardness :
Measured by electronic hardness teaser ( 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 )
( in vivo ) Measured by Tricorptester ( Okada Seiko Co., Ltd. Tokyo, Japan )
Friability :
Measured by JP general test method
Tableting Condition :
Rotary-Press, 6 stations, 20 rpm, 250mg, Φ8mm, Flat Beveled Edge

Contribution of unique Granulation to compaction property

Applying unique wet granulation method, GRANFILLER-D improves compaction property compared to simple mixture of individual ingredients.

graf03 graf03
Components of ODT:
GNF-D211( 99.5% ) +Mg Stearate ( 0.5% )
Tablet Hardness :
Measured by electronic hardness tester ( Ave. of n=10 )
Disintegration Time :
Measured by JP general test method ( Ave. of n=6 )
Tableting Conditions :
Hand-press tableting, 250mg, φ8mm, Flat Face Bevel Edge

Example application – High dose API

GRANFILLER-D makes high-dose formulation possible.

1. High-Dose Ethenzamide ( ETZ ) ODT

API Ethenzamide
API Content [ % ] 0 30 50 70
Compression Force ( kN ) 6 7 9 5 7 5
Tablet Hardness ( N ) 80 69 94 57 91 80
Disintegration Time ( s ) 15 16 19 15 18 18
Oral Disintegration Time ( s ) 16 16 21 16 25 -
Friability ( s ) 0.12 0.18 0.13 0.31 0.15 0.30
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( 06/2017 )