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 )
|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 Time [in vitro] ( s )||12||16||25||9||12||18|
|Friability ( % )||0.30||0.12||0.06||0.23||0.05||0.05|
- Components of ODT :
- GNF-D211/GNF-D215 ( 99.5% ) + Mg 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 )
( in vitro ) 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 shape
Contribution of unique Granulation to compaction property
Applying unique wet granulation method, GRANFILLER-D improves compaction property compared to simple mixture of individual ingredients.
- Components of ODT：
- GNF-D211( 99.5% ) ＋Mg Stearate ( 0.5% )
- Tablet Hardness ：
- Measured by electronic hardness tester ( Avg. of n＝10 )
- Disintegration Time ：
- Measured by JP general test method ( Avg. of n＝6 )
- Tableting Conditions ：
- Hand-press tableting, 250mg, φ8mm, Flat beveled edge shape
Example application – High dose API
GRANFILLER-D makes high-dose formulation possible.
1. High-Dose Ethenzamide ( ETZ ) ODT
|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 ( ％ )||0.12||0.18||0.13||0.31||0.15||0.30|
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( 06/2017 )