Ethyl Cellulose
Ethyl Cellulose is known as coating agent, microencapsulating agent, tablet and capsule binder, tablet and capsule diluent, taste-masking agent, viscosity-increasing agent. This product is available in Arvin Kala’s diverse product portfolio.
Description

Ethylcellulose is a flavorless, free-flowing powder that ranges in color from white to light tan. This substance is known by the chemical formula C_12 H_23 O_6 (C_12 H_22 O_5 )_n C_12 H_23 O_5, where n can vary, providing a range of molecular weights. Ethylcellulose, an ethyl ether of cellulose, is a long-chain polymer of ββ-anhydroglucose units linked together by acetal bonds. The structural formula of this substance is as follows:

Applications in Pharmaceutical Formulation or Technology
Ethylcellulose is extensively utilized in both oral and topical pharmaceutical formulations. In oral formulations, ethylcellulose primarily serves as a hydrophobic coating agent for tablets and granules. These coatings are employed to modify drug release, mask unpleasant tastes, or enhance formulation stability, such as by preventing oxidation in coated granules. Additionally, ethylcellulose can be used as a matrix former in modified-release tablet formulations. When dissolved in an organic solvent or solvent mixture, ethylcellulose can independently form water-insoluble films. Higher-viscosity grades of ethylcellulose typically produce stronger and more durable films. The solubility of these films can be adjusted by adding hypromellose or a plasticizer. Aqueous polymer dispersions (or latex) of ethylcellulose, like Aquacoat ECD or Surelease, can also be used to create films without organic solvents. Drug release from ethylcellulose-coated dosage forms is controlled by diffusion through the film coating, which can be slow unless a large surface area, such as pellets or granules, is used. Aqueous ethylcellulose dispersions are commonly used to coat granules or pellets, which can absorb pressure and protect the coating during compression. High-viscosity grades of ethylcellulose are also used in drug microencapsulation. The release of a drug from an ethylcellulose microcapsule depends on the wall thickness and surface area of the microcapsule. In tablet formulations, ethylcellulose can act as a binder, either blended dry or wet-granulated with a solvent like ethanol (95%). It produces hard tablets with low friability, though they may have poor dissolution. Ethylcellulose has also been used to deliver therapeutic agents from oral appliances, such as dental devices. In topical formulations, ethylcellulose functions as a thickening agent in creams, lotions, or gels, provided an appropriate solvent is used. It has been studied as a stabilizer for emulsions. Additionally, ethylcellulose is used in cosmetics and food products.
Stability and Storage Conditions
Ethylcellulose is a stable, mildly hygroscopic substance. It exhibits chemical resistance to both dilute and concentrated alkalis, as well as to salt solutions. However, it is more susceptible to acidic materials compared to cellulose esters. Exposure to sunlight or UV light at high temperatures can cause oxidative degradation of ethylcellulose. This can be mitigated by incorporating antioxidants and chemical additives that absorb light in the 230-340 nm range.
Method of Manufacture

Ethylcellulose is produced by treating purified cellulose, derived from chemical-grade cotton linters and wood pulp, with an alkaline solution. This is followed by the ethylation of the alkali cellulose using chloroethane, as illustrated below, where R denotes the cellulose radical:

RONa+C2H5Cl→ROC2H5+NaClRONa+C2H5Cl→ROC2H5+NaCl

The addition of ethyl groups to cellulose is characterized by the degree of substitution (DS). DS indicates the average number of hydroxyl positions on the anhydroglucose unit that have reacted with ethyl chloride. Each anhydroglucose unit in the cellulose molecule has three hydroxyl groups, so the maximum DS value is three.

Safety

Ethylcellulose is extensively utilized in both oral and topical pharmaceutical formulations, as well as in food products. Since it is not metabolized after oral consumption, it is considered a noncalorific substance. However, due to its lack of metabolism, ethylcellulose is not recommended for parenteral products, as it may pose a risk to the kidneys.
Generally, ethylcellulose is regarded as a nontoxic, nonallergenic, and nonirritating material.
Given that ethylcellulose is not considered a health hazard, the WHO has not specified an acceptable daily intake. The highest reported amount used in an oral product is 308.8 mg in a sustained-release tablet.

LD_50 (rabbit, skin): >5 g/kg
LD_50 (rat, oral): >5 g/kg

Handling Precautions
It’s crucial to prevent fine dust clouds of ethylcellulose from accumulating to potentially explosive levels in the air. Ethylcellulose is a combustible material. Additionally, ethylcellulose powder can irritate the eyes, so wearing eye protection is recommended.

Chemical-physical values

Test Item Unit Specification
APPEARANCE
WHITE POWDER OR GRANULES
ETHOXYL CONTENT
%wt
NLT 47.5 & NMT 49.5
VISCOSITY
cp
NLT 9.0 & NMT 11.0
LOSS ON DRYING
%wt
NMT 3.0
RESIDUE ON IGNITION
%wt
NMT 0.4
CHLORIDES
%wt
CONFORMS
HEAVE METALS
ppm
NMT 20

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