Cellulose acetate phthalate Property

solubility 

Practically insoluble in water, freely soluble in acetone, soluble in diethylene glycol, practically insoluble in ethanol (96 per cent) and in methylene chloride. It dissolves in dilute solutions of alkali hydroxides

EPA Substance Registry System

Cellulose, acetate hydrogen 1,2-benzenedicarboxylate (9004-38-0)

Safety

Hazard Codes 

Xn

Risk Statements 

20/21/22-36/37/38

Safety Statements 

24/25-36-26

WGK Germany 

3

RTECS 

FJ5692000

HS Code 

39129010

Hazard and Precautionary Statements (GHS)

Symbol(GHS)

Signal word

Warning

Hazard statements

H252Self-heating in large quantities; may catch fire

H315Causes skin irritation

H319Causes serious eye irritation

H335May cause respiratory irritation

Precautionary statements

P235+P410Keep cool. Protect from sunlight.

P264Wash hands thoroughly after handling.

P264Wash skin thouroughly after handling.

P280Wear protective gloves/protective clothing/eye protection/face protection.

P302+P352IF ON SKIN: wash with plenty of soap and water.

P305+P351+P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continuerinsing.

P321Specific treatment (see … on this label).

P332+P313IF SKIN irritation occurs: Get medical advice/attention.

P362Take off contaminated clothing and wash before reuse.

P407Maintain air gap between stacks/pallets.

P413Store bulk masses greater than … kg/…lbs at temperatures not exceeding … oC/…oF.

P420Store away from other materials.

Cellulose acetate phthalate Chemical Properties,Usage,Production

Chemical Properties

white granular powder

Chemical Properties

Cellulose acetate phthalate is a hygroscopic, white to off-white, freeflowing powder, granule, or flake. It is tasteless and odorless, or might have a slight odor of acetic acid.

Uses

Enteric coating in pharmaceutical products.

Production Methods

Cellulose acetate phthalate is produced by reacting the partial acetate ester of cellulose with phthalic anhydride in the presence of a tertiary organic base such as pyridine, or a strong acid such as sulfuric acid.

Pharmaceutical Applications

Cellulose acetate phthalate (CAP) is used as an enteric film coating material, or as a matrix binder for tablets and capsules. Such coatings resist prolonged contact with the strongly acidic gastric fluid, but dissolve in the mildly acidic or neutral intestinal environment.
Cellulose acetate phthalate is commonly applied to solid-dosage forms either by coating from organic or aqueous solvent systems, or by direct compression. Concentrations generally used are 0.5–9.0% of the core weight. The addition of plasticizers improves the water resistance of this coating material, and formulations using such plasticizers are more effective than when cellulose acetate phthalate is used alone.
Cellulose acetate phthalate is compatible with many plasticizers, including acetylated monoglyceride; butyl phthalybutyl glycolate; dibutyl tartrate; diethyl phthalate; dimethyl phthalate; ethyl phthalylethyl glycolate; glycerin; propylene glycol; triacetin; triacetin citrate; and tripropionin. It is also used in combination with other coating agents such as ethyl cellulose, in drug controlledrelease preparations.
Therapeutically, cellulose acetate phthalate has recently been reported to exhibit experimental microbicidal activity against sexually transmitted disease pathogens, such as the HIV-1 retrovirus.

Safety Profile

An experimental teratogen. When heated to decomposition it emits acrid smoke and irritating fumes.

Safety

Cellulose acetate phthalate is widely used in oral pharmaceutical products and is generally regarded as a nontoxic material, free of adverse effects. Results of long-term feeding in rats and dogs have indicated a low oral toxicity. Rats survived daily feedings of up to 30% in the diet for up to 1 year without showing a depression in growth. Dogs fed 16 g daily in the diet for 1 year remained normal.

storage

Slow hydrolysis of cellulose acetate phthalate will occur under prolonged adverse conditions such as high temperatures and high humidity, with a resultant increase in free acid content, viscosity, and odor of acetic acid. However, cellulose acetate phthalate is stable if stored in a well-closed container in a cool, dry place.

Incompatibilities

Cellulose acetate phthalate is incompatible with ferrous sulfate, ferric chloride, silver nitrate, sodium citrate, aluminum sulfate, calcium chloride, mercuric chloride, barium nitrate, basic lead acetate, and strong oxidizing agents such as strong alkalis and acids.

Regulatory Status

Included in the FDA Inactive Ingredients Database (oral tablets). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.