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Neusilin® US2
Neusilin® US2 is a pH-neutral, specialty excipient with low water content. This multifunctional, amorphous form of magnesium aluminometasilicate has good oil adsorption capacity to convert pharmaceutical API oils and extracts to powders.
- Manufacturer: Fuji Chemical Industries USA, Inc
- Product Line: Neusilin®
- Product: Neusilin® Neutral Grades
- Industries: Food & Beverage | Pharmaceuticals
- Authorized Countries: United States
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Overview
CAS # 12511-31-8
Neusilin® US2 has shown to be an exceptional adsorbent carrier for solid dispersion preparation via hot melt extrusion (HME) and Self Micro-Emulsifying Drug Delivery Systems (SMEDDS). Neusilin® US2 allows preparation of a stable amorphous drug complex without any addition of polymers, waxes, or plasticizers normally associated with hot-melt extrusion.
Compression with Neusilin® US2 generally gives harder tablets compared to compression with colloidal silica.
Specifications
Appearance: White granules
Degree of whiteness: > 95%
Physical form: Amorphous
True specific gravity: 2.2
Solubility: Practically insoluble in water and ethanol
Composition on dried basis:
Al2O3: 29.1% - 35.5%
MgO: 11.4% - 14.0%
SiO2: 29.2% - 35.6%
Loss on drying (110°C, 7 hours): < 7%
Loose bulk density (g/mL): 0.13 - 0.18
Tapped bulk density (g/mL): 0.16 - 0.22
Specific surface area (m²/g): 300
Average particle size (μm): 106
Angle of repose: 30°
Oil adsorbing capacity (mL/g): 2.7 - 3.4
Water adsorbing capacity (mL/g): 2.4 - 3.1
Acid consuming capacity (mL/g): ≥ 210
pH (4% slurry): 6.0 - 8.0
EINECS number: 235-682-0
Chemical formula: Al2O3·MgO·1.7SiO2·xH2O
Features & Benefits
- Superior compressibility; hard tablets can be made at low compression force
- Improves hardness of other fillers and binders at low concentration
- Helps stabilize moisture-sensitive and lipophilic APIs
- Excellent carrier for solid dispersion via self-micro emulsifying drug delivery system (SMEDDS) and hot-melt extrusion
- Very large specific surface area
- High oil and water adsorption capacity
- Higher API load
- Restricts reversion of amorphous form to crystalline state
- Inert core material
- Heat stable
- Long shelf life (3 years)
- Meets all the requirements of the current USP/NF and JPC
Applications
Neusilin® US2 can be used as an excipient in a variety of applications. It stabilizes deliquescent drugs and solidifies liquid APIs when its necessary to convert them from an oil to a powder, for example. It is also used to bind, increase hardness, and aid in disintegration for tablets. Neusilin® US2 can be used to prepare high quality tablets with a load of up to 30% Vitamin E. Additionally, it can be a diluent in solid dosage forms.
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