GRANFILLER-D™ is a co-processed excipient for orally disintegrating tablets, ODTs.
A ODT with GRANFILLER-D™ is quickly disintegrated by touch with water.
GRANFILLER-D™ Features
GRANFILLER-D™ is a co-processed excipient for direct compression ODTs, jointly developed by NICHIRIN Chemical Industries, Ltd. and DAICEL Group. It was originally designed to achieve compatibility between high tablet hardness and rapid disintegration in the direct compression method of tablet production. GRANFILLER-D™ consists of D-mannitol, Crospovidone, Carmellose, and Microcrystalline cellulose. The characteristic non-spherical particle shape contributes to good content uniformity. Furthermore, it is compatible with a wide range of excipients, maintaining good disintegratability. GRANFILLER-D™ contributes to the simplification and efficiency of ODT formulation design.
- Well-balanced tablet property between OD time and hardness
- High API loading capacity
- Excellent content uniformity
- Compatible with various excipients
Regulation
- All components of GRANFILLER-D™ are included in JP, USP and EP.
- Both GNF-D211 and GNF-D215 are included in JPE2018 (Japanese pharmaceutical excipients 2018).
- Both US-DMF and China-DMF are available for GNF-D211.
Powder properties
The particles of GRANFILLER-D™ has non-spherical shape since it is processed by our unique granulation method. This special shape contributes to good content uniformity.
SEM photographs of GRANFILLER-D™
GNF-D211
GNF-D215
Powder Properties
| Items | GNF-D211 | GNF-D215 |
|---|---|---|
| Mean particle size※1 | (Median) 100 μm | (Median) 140 μm |
| Density (Loose) | 0.30 g/cm3 | 0.31 g/cm3 |
| Density (Tapping) | 0.44 g/cm3 | 0.43 g/cm3 |
| Angle of repose | 40 ° | 39 ° |
| Orifice diameter | 6.3 mm | 4.0 mm |
| Water content | 3.8 wt% | 3.7 wt% |
※1 Measured by dry laser diffraction/scattering instrument
Particle size distribution
Placebo tablet performance
Placebo ODTs with GRANFILLER-D™ have well-balanced tablet property between sufficient tablet hardness and rapid disintegration. Tablets with GRANFILLER-D™ achieve “100 N tablet hardness” and “20 seconds OD time”. Rapid disintegration is maintained even with the high tablet hardness under the higher compression force.
Tablet performance of placebo ODTs
GRANFILLER-D™ enables good tablet performance even with high dose API.
Other applications
- GRANFiLLER-D™-Water absorption behavior and disintegration mechanism-
- Preparetion of bitterness masking ODTs
- Preparetion of bilayer ODTs
- Preparetion of mini ODTs
GRANFILLER-D™ contributes to the simplification and efficiency of ODT formulation design.
Leaflet on GRANFILLER-D™ is available.
