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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.
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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.
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
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
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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