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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.
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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