Colloidal Silicon Dioxide(aerosil)

1. Nonproprietary Names
 BP: Colloidal anhydrous silica
 PhEur: Silica colloidalis anhydrica
 USPNF: Colloidal silicon dioxide

2. Synonyms

Aerosil; Cab-O-Sil; Cab-O-Sil M-5P; colloidal silica; fumed silica; light anhydrous silicic acid; silicic anhydride;
silicon dioxide fumed; Wacker HDK.

3. Chemical Name and CAS Registry Number

Silica [7631-86-9]

4. Empirical Formula and Molecular Weight

SiO2 60.08

5. Structural Formula

SiO2

6. Functional Category

Adsorbent; anticaking agent; emulsion stabilizer; glidant; suspending agent; tablet disintegrant; thermal stabilizer;
viscosity-increasing agent.

7. Applications in Pharmaceutical Formulation or Technology

Colloidal silicon dioxide is widely used in pharmaceuticals, cosmetics, and food products; see Table I. Its small
particle size and large specific surface area give it desirable flow characteristics that are exploited to improve the
flow properties of dry powders in a number of processes such as tableting.1–3

Table I
Table I: Uses of colloidal silicon dioxide.

Use Concentration (%)

Aerosols 0.5–2.0

Emulsion stabilizer 1.0–5.0

Glidant 0.1–0.5

Suspending and thickening 2.0–10.0

agent
Colloidal silicon dioxide is also used to stabilize emulsions and as a thixotropic thickening and suspending agent
in gels and semisolid preparations.4 With other ingredients of similar refractive index, transparent gels may be
formed. The degree of viscosity increase depends on the polarity of the liquid (polar liquids generally require a
greater concentration of colloidal silicon dioxide than nonpolar liquids). Viscosity is largely independent of
temperature. However, changes to the pH of a system may affect the viscosity; see Section 11.

In aerosols, other than those for inhalation, colloidal silicon dioxide is used to promote particulate suspension,
eliminate hard settling, and minimize the clogging of spray nozzles. Colloidal silicon dioxide is also used as a
tablet disintegrant and as an adsorbent dispersing agent for liquids in powders.5 Colloidal silicon dioxide is
frequently added to suppository formulations containing lipophilic excipients to increase viscosity, prevent
sedimentation during molding, and decrease the release rate.6,7 Colloidal silicone dioxide is also used as an
adsorbent during the preparation of wax microspheres;8 as a thickening agent for topical preparations;9 and has
been used to aid the freeze-drying of nanocapsules and nanosphere suspensions.10

8. Description

Colloidal silicon dioxide is a submicroscopic fumed silica with a particle size of about 15 nm. It is a light, loose,
bluish-white-colored, odorless, tasteless, nongritty amorphous powder.

9. Pharmacopeial Specifications
Table II: Pharmacopeial specifications for colloidal silicon dioxide.

Test PhEur 2005 USPNF 23

Identification + +

Characters + —

pH (4% w/v dispersion) 3.5–5.5 3.5–5.5

Arsenic — ≤8 μg/g

Chloride ≤250 ppm —

Heavy metals ≤25 ppm —

Loss on drying — ≤2.5%

Loss on ignition ≤5.0% ≤2.0%

Organic volatile — +
impurities

Assay (on ignited sample) 99.0–100.5% 99.0–100.5%

10. Typical Properties

Acidity/alkalinity:

 
pH = 3.5–4.4 (4% w/v aqueous dispersion)
Density (bulk):

 
0.029–0.042 g/cm3

Density (tapped):

 
See Tables III, IV and V.

Table III
Table III: Physical properties of Aerosil.

Grad
Specific surface areaa (m2/g) Density (tapped) (g/cm3)
e

130 130 ± 25 0.05

130vs 130 ± 25 0.12

200 200 ± 25 0.05

200vs 200 ± 25 0.12

300 300 ± 30 0.05

380 380 ± 30 0.05

(a)
BET method.

Flowability:

 
35.52% (Carr compressibility index)

Moisture content:

 
See Figure 1.11,12

Figure 1
 Figure 1: Sorption–desorption isotherm for colloidal silicon dioxide.
○: Sorption
■: Desorption

Particle size distribution:

 
7–16 nm. See also Figure 2.

Figure 2

Figure 2: Particle size distribution of colloidal silicon dioxide ( Aerosil A-200).

Refractive index:
 
1.46

Solubility:

 
practically insoluble in organic solvents, water, and acids, except hydrofluoric acid; soluble in hot solutions of
alkali hydroxide. Forms a colloidal dispersion with water.

Specific gravity:

 
2.2

Specific surface area:

 
200–400 m2/g (Stroehlein apparatus, single point); 50–380 m2/g (BET method). See also Tables III, IV and V.

Several grades of colloidal silicon dioxide are commercially available, which are produced by modifying the
manufacturing process. The modifications do not affect the silica content, specific gravity, refractive index, color,
or amorphous form. However, particle size, surface areas, and densities are affected. The physical properties of
three commercially available colloidal silicon dioxides, Aerosil (Degussa), Cab-O-Sil (Cabot Corporation), and
Wacker HDK (Wacker-Chemie GmbH) are shown in Tables III, IV and V, respectively.

11. Stability and Storage Conditions

Colloidal silicon dioxide is hygroscopic but adsorbs large quantities of water without liquefying. When used in
aqueous systems at a pH 0–7.5, colloidal silicon dioxide is effective in increasing the viscosity of a system.
However, at a pH greater than 7.5 the viscosity-increasing properties of colloidal silicon dioxide are reduced; and
at a pH greater than 10.7 this ability is lost entirely since the silicon dioxide dissolves to form silicates.13 Colloidal
silicon dioxide powder should be stored in a well-closed container.

Some grades of colloidal silicon dioxide have hydrophobic surface treatments that greatly minimize their
hygroscopicity.

12. Incompatibilities

Incompatible with diethylstilbestrol preparations.15

13. Method of Manufacture

Colloidal silicon dioxide is prepared by the vapor hydrolysis of chlorosilanes, such as silicon tetrachloride, at
1800°C using a hydrogen–oxygen flame.

14. Safety

Colloidal silicon dioxide is widely used in oral and topical pharmaceutical products and is generally regarded as
an essentially nontoxic and nonirritant excipient. However, intraperitoneal and subcutaneous injection may
produce local tissue reactions and/or granulomas. Colloidal silicon dioxide should therefore not be administered
parenterally.

LD50 (rat, IV): 15 mg/kg16

LD50 (rat, oral): 3.16 g/kg
15. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection
and gloves are recommended. Precautions should be taken to avoid inhalation of colloidal silicon dioxide. In the
absence of suitable containment facilities, a dust mask should be worn when handling small quantities of material.
For larger quantities, a dust respirator is recommended.

Inhalation of colloidal silicon dioxide dust may cause irritation to the respiratory tract but it is not associated with
fibrosis of the lungs (silicosis), which can occur upon exposure to crystalline silica.

16. Regulatory Acceptance

GRAS listed. Included in the FDA Inactive Ingredients Guide (oral capsules, suspensions, and tablets;
transdermal and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the
Canadian List of Acceptable Non-medicinal Ingredients.