Neusilin® US2 is a synthetic, amorphous form of magnesium aluminometasilicate. It is a multifunctional excipient that can be used in both direct compression and wet granulation of solid dosage forms. Neusilin® is widely used for improvement of the quality of tablets, powder, granules and capsules. Neusilin® does not develop gel with aqueous solutions unlike other magnesium aluminum silicates. The different grades of Neusilin® have been highly evaluated at home and abroad. It has a market presence of over 60 years in Japan.

Chemical Name: Magnesium Aluminosilicate

CAS Number: 71205-22-6

Functions: Antacid, Binder, Disintegrant

Dosage Form: Orally Disintegrating Tablets (ODTs)

Synonyms: Almasilate, Malinal, SC 306

Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
71205-22-6
Chemical Structure Description

Neusilin® is amorphous and contains either tetrahedron or octahedron of Al, octahedron of Mg and tetrahedron of Si which are randomly attached to form a complex three dimensional structure. Neusilin® does not possess repeating units of a defined monomer.

Features & Benefits

Characteristics
  1. Neusilin® is Magnesium Aluminometasilicate in either fine powder or granule form.
  2. Neusilin® is represented by an empirical formula Al2O3·MgO·1.7SiO2·xH2O.
  3. Neusilin® is amorphous, possesses very large specific surface area and has high oil and water adsorption capacity.
  4. Neusilin® is superior in compressibility which enables to make hard tablets at low compression force. It can also improve hardness of other fillers and binders of low concentration.
  5. Compounding with Neusilin® helps stabilize moisture sensitive as well as lipophilic APIs.
  6. Neusilin® is stable against heat and has a long shelf life.
  7. Neusilin® is available in various grades. The grades differ in their bulk density, water content, particle size and pH.
  8. Neusilin® is an excellent carrier for solid dispersion via self-micro emulsifying drug delivery system (SMEDDS) and Hot-Melt Extrusion.

Applications & Uses

Applications
  • Flow Improvement
  • Hardness Improvement
  • Oil to powder conversion
  • Drug protection
Dosage and Safety

Neusilin® is safe with no reports of adverse reactions and is an accepted ingredient by the USP/NF and JPC. Based on the usage as an excipient in various formulations in Japan, Neusilin® up to 1.05 g can be used for oral uptake per day.* There are no established maximum oral intake limits specified by US-FDA.

Properties

Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
Degree of Whitenessmin. 95%
Loss on Drying at 110 °C for 7 hrsmax. 7
Loose Bulk Density0.13-0.18g/ml
Tapped Bulk Density0.16-0.22g/ml
True Specific Gravity2.2
Specific Surface Area300m2/gBET
Mean Particle Size Distribution106μm
Angle of Repose30°
Oil Adsorbing Capacity2.7-3.4ml/gJIS K5101
Water Adsorbing Capacity2.4-3.1ml/g
Acid Consuming Capacitymax. 210ml/g
pH of 4% Slurry6.0-8.0

Regulatory & Compliance

Pharmacopoeia and Regulatory Information

Neusilin® meets all the requirements of the current USP/NF and JPC. An US DMF type IV filed in 1998.

Technical Details & Test Data

Conclusions

Neusilin® is a totally synthetic magnesium aluminometasilicate with exceptional excipient properties to improve API delivery and quality of oral solid-dosage form pharmaceuticals. Neusilin® is available in four grades and the two different pH options make it a versatile excipient for a wide-variety of applications.

With over 500 pharmaceutical preparations and a market presence of over 60 years in Japan, Neusilin® is well accepted by the formulators world-wide as an aid for formulations containing antibiotics, oily actives, poorly water soluble APIs, herbal mixtures, vitamins, etc. Neusilin® is also used as carrier for preparation of solid dispersion and self-micro emulsifying drug development systems.

Neusilin® has been demonstrated as an excellent adsorbent carrier for solid dispersion preparation via hot melt granulation, Self MicroEmulsifying Drug Delivery Systems (SMEDDS) for BCS class II drugs such as meloxicam, naproxen, ketoprofen, glyburide and other highly permeable but poorly water soluble drugs. The most exciting use of Neusilin® is in Hot Melt Extrusion (HME). Neusilin® allows preparation of stable amorphous drug complex without any addition of polymers, waxes or plasticizers normally associated with HME. The samples can be recovered as amorphous powder and converted to highly stable tablets through direct compression.

Packaging & Availability

Packaging

Package size 10 Kg

Storage & Handling

Stability

Neusilin® is a stable inorganic compound and meets JPC and NF specifications. The shelf life of Neusilin® is 3 years from the date of manufacture.