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 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 | 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 ( ％ ) | 0.12 | 0.18 | 0.13 | 0.31 | 0.15 | 0.30 |
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( 06/2017 )