Titanium Dioxide
Lactose monohydrate is known as Coating agent, opacifier and pigment. This product is available in Arvin Kala’s diverse product portfolio.
Description
White, amorphous, odorless, and tasteless nonhygroscopic powder. Although the average particle size of titanium dioxide powder is less than 1 mm, commercial titanium dioxide generally occurs as aggregated particles of approximately 100 mm diameter.
Titanium dioxide may occur in several different crystalline forms: rutile; anatase; and brookite. Of these, rutile and anatase are the only forms of commercial importance. Rutile is the more thermodynamically stable crystalline form, but anatase is the form most commonly used in pharmaceutical applications.
Applications in Pharmaceutical Formulation or Technology
Titanium dioxide is widely used in confectionery, cosmetics, and foods, in the plastics industry, and in topical and oral pharmaceutical formulations as a white pigment.
Owing to its high refractive index, titanium dioxide has lightscattering properties that may be exploited in its use as a white pigment and opacifier. The range of light that is scattered can be altered by varying the particle size of the titanium dioxide powder. For example, titanium dioxide with an average particle size of 230 nm scatters visible light, while titanium dioxide with an average particle size of 60 nm scatters ultraviolet light and reflects visible light.
In pharmaceutical formulations, titanium dioxide is used as a white pigment in film-coating suspensions, sugar-coated tablets, and gelatin capsules. Titanium dioxide may also be admixed with other pigments.
Titanium dioxide is also used in dermatological preparations and cosmetics, such as sunscreens.
Stability and Storage Conditions
Titanium dioxide is extremely stable at high temperatures. This is due to the strong bond between the tetravalent titanium ion and the bivalent oxygen ions. However, titanium dioxide can lose small, unweighable amounts of oxygen by interaction with radiant energy. This oxygen can easily recombine again as a part of a reversible photochemical reaction, particularly if there is no oxidizable material available. These small oxygen losses are important because they can cause significant changes in the optical and electrical properties of the pigment.
Titanium dioxide should be stored in a well-closed container, protected from light, in a cool, dry place.
Method of Manufacture
Titanium dioxide occurs naturally as the minerals rutile (tetragonal structure), anatase (tetragonal structure), and brookite (orthorhombic structure).
Titanium dioxide may be prepared commercially by either the sulfate or chloride process. In the sulfate process a titanium containing ore, such as ilemenite, is digested in sulfuric acid. This step is followed by dissolving the sulfates in water, then precipitating the hydrous titanium dioxide using hydrolysis. Finally, the product is calcinated at high temperature. In the chloride process, the dry ore is chlorinated at high temperature to form titanium tetrachloride, which is subsequently oxidized to form titanium dioxide.
Safety
Titanium dioxide is widely used in foods and oral and topical pharmaceutical formulations. It is generally regarded as an essentially nonirritant and nontoxic excipient.
Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection, gloves, and a dust mask are recommended. Titanium dioxide is regarded as a relatively innocuous nuisance dust, that may be irritant to the respiratory tract. In the UK, the long-term (8-hour TWA) workplace exposure limit is 10 mg/m3 for total inhalable dust and 4 mg/m3 for respirable dust.
Titanium dioxide particles in the 500 nm range have been reported to translocate to all major body organs after oral administration in the rat.
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
White,amorphous, odorless,and tasteless nonhygroscopiec Powder |
|
Assay — Dried Basis |
% |
Min 99.0 &
Max 100.5
|
|
Loss on Drying(105°C) |
% |
Max 0.5 |
|
Loss on Ignition(800°C) |
% |
Max 0.5 |
|
Water Soluble substances |
% |
Max 0.25 |
| Test Item | Unit | Specification |
|---|---|---|
|
Acid Soluble substances |
% |
Max 0.5 |
|
Lead |
Mg/kg |
Max 3 |
|
Iron |
Mg/kg |
Max 200 |
|
Arsenic |
Mg/kg |
Max 1 |
|
Antimony |
Mg/kg |
Max 100 |
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