Colloidal Silicon Dioxide

Colloidal silicon dioxide is known as an absorbent, anti-caking agent, emulsion stabilizer, slip agent, suspension agent, tablet disintegrator, thermal stabilizer and viscosity increasing agent. Silicon dioxide is one of the ingredients in Arvin Kala’s diverse product portfolio.

Description

Colloidal silicon dioxide is a submicroscopic fumed silica with particles approximately 15 nm in size. It appears as a light, loose, bluish-white, odorless, tasteless, and amorphous powder.

Applications in Pharmaceutical Formulation or Technology

Colloidal silicon dioxide is extensively utilized in pharmaceuticals, cosmetics, and food products. Its tiny particle size and large specific surface area provide excellent flow characteristics, which are beneficial for enhancing the flow properties of dry powders in various processes like tableting and capsule filling.

Colloidal silicon dioxide is also employed to stabilize emulsions and acts as a thixotropic thickening and suspending agent in gels and semisolid preparations. When combined with other ingredients of similar refractive index, it can form transparent gels. The extent of viscosity increase depends on the liquid’s polarity, with polar liquids generally requiring a higher concentration of colloidal silicon dioxide than nonpolar ones. Viscosity is largely unaffected by temperature, but changes in the system’s pH can influence it.

In aerosols, excluding those for inhalation, colloidal silicon dioxide is utilized to enhance particulate suspension, prevent hard settling, and reduce spray nozzle clogging. It also serves as a tablet disintegrant and an adsorbent dispersing agent for liquids in powders. In suppository formulations with lipophilic excipients, it is frequently added to increase viscosity, prevent sedimentation during molding, and slow the release rate. Additionally, colloidal silicon dioxide is used as an adsorbent in the preparation of wax microspheres, as a thickening agent for topical preparations, and to assist in the freeze-drying of nanocapsules and nanosphere suspensions.

Stability and Storage Conditions

Colloidal silicon dioxide is hygroscopic, meaning it can absorb large amounts of water without liquefying. In aqueous systems with a pH of 0 to 7.5, it effectively increases viscosity. However, its viscosity-enhancing properties diminish at pH levels above 7.5 and are completely lost at pH levels above 10.7, as the silicon dioxide dissolves to form silicates. Colloidal silicon dioxide powder should be stored in a well-sealed container.

Method of Manufacture

Colloidal silicon dioxide is produced through the flame hydrolysis of chlorosilanes, such as silicon tetrachloride, at 1800°C using a hydrogen–oxygen flame. Rapid cooling from the molten state during the manufacturing process ensures that the product remains amorphous.

Safety

Colloidal silicon dioxide is commonly used in oral and topical pharmaceutical products and is generally considered a nontoxic and nonirritant excipient. However, intraperitoneal and subcutaneous injections can cause local tissue reactions and/or granulomas. Therefore, colloidal silicon dioxide should not be administered parenterally.

LD50 (rat, IV): 0.015 g/kg

LD50 (rat, oral): 3.16 g/kg

Handling Precautions

Follow standard precautions based on the circumstances and amount of material being handled. It is recommended to use eye protection and gloves. As colloidal silicon dioxide is considered a nuisance dust, measures should be taken to avoid inhalation. If proper containment facilities are not available, a dust mask should be worn when handling small quantities. For larger quantities, a dust respirator is advised.

Inhaling colloidal silicon dioxide dust may irritate the respiratory tract, but it is not linked to lung fibrosis (silicosis), which can result from exposure to crystalline silica.

Chemical-physical values

TEST ITEM Unit Specification
Appearance
/
White or almost white, light, fine, amorphous powder, with a particle size of about 15 nm
Solubility
/
Practically insoluble in water and mineral acids except hydrofluoric acid. It dissolves slowly in hot solution of alkali hydroxides.
pH
/
between 3.5 5.5
Loss on Ignition
WT%
Max 2.0
Arsenic
ppm
Max 8
Loss on Drying
WT%
Max 2.5
TEST ITEM Unit Specification
Chlorides
ppm
Max 250
Assay
WT%
Min 99 & Max 100.5
Specific Surface Are
m2/g
about 200
Tap Densit
g/L
Min 40 & Max 60
heavy Metal
ppm
Max 25
The total aerobic microbial
Cfu/g
Max 1000
The total combined molds and yeasts count
Cfu/g
Max 100
Escherichia col
/
Can not be detected

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